Open call

17 January - 20 February 2024

Grant for clinical study in therapy research

The purpose of the grant is to provide support for clinical therapy studies that are justified by the needs of health and medical care and are expected to lead to patient and societal benefit within a relatively short period of time. A clinical study in therapy research includes both intervention and observation studies, and areas such as prevention, diagnostics, follow-up, implementation, care, and rehabilitation are also included. The grant aims to enable a grouping of researchers within regions and academia to collaborate with a common research goal.

Subject area: Clinical Therapy Research

Support form: Research environment and collaboration support

Grant form: Research environment grant

Focus: Clinical therapy research

Applicant: Individual researcher

Participating researchers:
In Step 1 (outline application), participating researchers shall be listed in the text but cannot be invited to join the application.
In Step 2 (full application), a minimum of 3 and maximum of 10 other researchers shall be invited to join the application.

Grant period: 4 years

Grant amount: Minimum 1 000 000 SEK per year, maximum 20 000 000 SEK over the entire 4-year period

Start of grant period: January 2025

Application period: 17 January 2024 (14.00/2 pm) – 20 February 2024 (14.00/2 pm)

Publication of grant award: No later than the beginning of December 2024

Please note:

  • The former “Publication list” is now known as “Publications and other research outputs” and has a changed structure.
  • There is now a separate field in the application where you are asked to describe how your stated merits confirm your ability to implement the proposed research.
  • Please note that the application is made using a two-step procedure, and this text also includes instructions for Step 2. Only a small number of applicants will be included in Step 2. If you are included in Step2, your full application must justify any changes you have made compared to Step 1.
  • This call requires national collaboration between a minimum of 4 regions, unless there are special reasons, and also that the application shall include user participation.
  • The grant may not be applied for to continue research or a study that has already been awarded a grant for a clinical study in therapy research by the Swedish Research Council.
  • Read here for information on project collaboration with researchers in Russia and Belarus.

Specific instructions for the call

In addition to reading the call text, you also need to consult our Guide for applicants.

Contents:

Application procedure

Applications for a grant for clinical study in therapy research are made using a two-step procedure. In Step 1, you as applicant shall submit an outline application for assessment. If your application is selected for Step 2, you shall submit a full application.

Step 1 (outline application)

In the outline application, the emphasis shall be on the research question and the expected patient benefit and societal benefit. The study design, statistical method and materials shall be described briefly, but sufficiently clearly to allow the feasibility of the project idea to be assessed.

The Swedish Research Council will make a decision on the outline applications in May 2024. If your outline application is accepted, you will receive notice via email, including instructions for how to submit a full application in Step 2. Relevant information will automatically be transferred from the outline application to your draft for the full application.

Step 2 (full application)

The call for full applications will be open from 29 May to 20 August 2024.

Compared to the outline application, the full application must include the following:

  • a more comprehensive research plan and specific timed interim goals to be reported back and evaluated on an ongoing basis
  • a full budget description
  • CV details and publications of the participating researchers (minimum 3 and maximum 10)

The application in Step2 may also include more detailed information on ethical aspects, sex and gender perspectives, clinical benefit, user participation, feasibility, implementation and national collaboration, or other changes that you may justify as being necessary. It is important that you read the instructions for what must be included in the application in Step2 already when applying in Step 1. You cannot make changes in Step 2 that mean you no longer fulfil the requirements for the call.

Contrary to what applies to the outline application, the full application must also be signed by an authorised representative of the administrating organisation within 7 calendar days from the deadline for applications.

Information and support to make the planning ahead of your application easier

Clinical Studies Sweden – regional support for your work

The six regional nodes that together form Clinical Studies Sweden offer various types of support for work on a clinical study. Examples include help with study protocols, permit applications, data management and statistics, infrastructures for implementation, and training in clinical research methodology. The nodes also have a good supply of knowledge, and can provide contacts with relevant regional resources, such as research units, quality register centres, biobanks, and cancer centres. More information about Clinical Studies Sweden and what you need to consider when conducting a clinical study can be found at kliniskastudier.se. External link.

Registering and reporting clinical studies

There are guidelines for study registration and result reporting for the clinical studies funded by the Swedish Research Council, which means that information about the study shall be registered in a public study register, and that a summary of the results shall be published in the register. More information is available here.

Practical tips and advice relating to register-based studies

Registerforskning.se has practical information for those who are planning to use register data in their research projects, including a step-by-step guide. Here you can also find the metadata tool RUT (Register Utiliser Tool), which offers researchers detailed information at metadata level about the variables used in the Swedish registers and biobank sample collections linked to the tool. New registers are continually being added to RUT.

Open publication of data relevant to COVID-19

If you are awarded a grant, you are expected to publish your research data and research results of relevance to COVID-19 with open access as quickly as possible. Determining what data can be published with open access shall always be based on applicable legislation. Please use the national pathogen portal External link.to make your data accessible when possible. Here you can also get practical support with data management and data sharing. The data portal, which is operated by SciLifeLab in collaboration with the Swedish Research Council, is linked to the European COVID-19 data portal. External link.

Requirements for applicants

The following requirements must be fulfilled for you to be eligible to apply for the grant. We carry out checks and reject applications that do not fulfil the requirements.

Focus

The research must be clinical; that is, research in medicine and health sciences that assumes the structures and resources of healthcare, and has the goal of solving an ill-health problem, or identifying factors that lead to improved health. The research should aim to fill a knowledge gap. Projects that are relevant for this call are clinical studies in therapy research, aimed at producing reliable and implementable results that can be of benefit to patients and society within a relatively short period of time (within 5 years of the project’s implementation). National collaboration is a requirement, and the main part of the research in the application shall be conducted in Sweden. Please note that you cannot apply for a grant to continue research or a study that has previously been awarded a grant for a clinical study in therapy research by the Swedish Research Council.

Applicant

The applicant for a grant for a clinical study in therapy research must be an individual researcher together with their organisation (a Swedish Higher Education Institution (HEI) or another Swedish organisation that fulfils the criteria for administrating organisations for Swedish Research Council grants). The Swedish Research Council must have approved your organisation as an administrating organisation for you to apply.

You must hold a Swedish doctoral degree or an equivalent foreign degree, awarded no later than the deadline for this call. For applicants with Swedish doctoral degrees, the award date listed in Ladok applies.

You shall be the project leader and have scientific responsibility for the research activities described. The time you set aside for the project (your activity level, that is the percentage of a full-time equivalent) must be suited to the task and its implementation throughout the grant period. Your experience of implementing and leading clinical studies in therapy research is important, as is the participating researchers’ and the project organisation’s experience of this. This must be described in your application (see instructions under “Research plan” below).

At the time of application and throughout the grant period, you must hold a clinical position in Sweden, that is to say be employed and carry out clinical work as, for example, a physician, nurse, dentist or physiotherapist. The scope of this employment must correspond to a minimum of 20 per cent of a full-time equivalent. You must describe the clinical work in your application (see instructions under “Clinical position” below).

You do not have to be employed by the administrating organisation at the time of application, but you must be employed at the start of and throughout the grant period and any further additional availability period. The employment must equal at least 20 per cent of a full-time equivalent.

Number of applications and previous grants

The requirements described in this section only apply to you as applicant and project leader.

General information about overlaps between applications and grants

Your application must not cover costs for purposes that are already funded by the Swedish Research Council or any other funding body. Overlaps with other grants or applications may impact on the grant amount you are awarded, or be a reason for us to reject your application.

What grants may I apply for simultaneously from the Swedish Research Council?

Applications for grants for a clinical study in therapy research and project or career grants

You may apply for a grant for a clinical study in therapy research at the same time as you apply for a project grant or career grant, but if these applications form part of your application for a grant for a clinical study in therapy research, this will be considered during the overall weighted assessment of the resource requirement.

Number of applications for grants for a clinical study in therapy research

You may only submit, that is be the applicant for, one application for a grant for a clinical study in therapy research under this call. On the other hand, you may be included as a participating researcher in several applications under the call.

Please note that you can only apply for a grant under the Swedish Research Council’s separate call for planning of clinical study in therapy research if you are not selected or choose not to submit a full application in Step 2.

You may not apply for a grant under any other of the Swedish Research Council’s calls for grants to a research environment, but you may be included as a participating researcher in such applications.

Further information about the grants you may apply for during the same year are shown in on the page Several grants simultaneously.

What requirements apply if I already have a grant from the Swedish Research Council?

There are certain restrictions if you are the project leader of an ongoing grant, that is to say a grant with a grant period that overlaps the period of the grant the application relates to. Please note that the availability period, that is to say the time during which you have the right to use your grant, is normally longer than the grant period. You can find information about the requirements for your ongoing grant in the “Approval of terms and conditions” you received from the Swedish Research Council.

If you have already been awarded a career or project grant

You may apply for a grant for a clinical study in therapy research if you are the project leader for an ongoing career grant or other project grant (however not if this is a grant for planning a clinical study in therapy research). A precondition for the application to be successful is that the grant awarded is not part of an application for a grant for a clinical study in therapy research, but it may be complementary.

If you have already been awarded a research environment grant

You may not apply for this grant if you are the project leader for an ongoing research environment grant.

If you have already been awarded a grant within the distinguished professor programme, or are a researcher recruited under the Swedish Research Council’s call for international recruitment

If you have a distinguished professor grant with a grant period that overlaps the grant period for this call, or are a researcher recruited through the Swedish Research Council’s international recruitment call, you cannot apply for a grant for a clinical study in therapy research. On the other hand, you may participate in such an application.

If you already have an ongoing grant, then further information about the grants you may apply for are shown in on the page Several grants simultaneously.

Note: If you have been the project leader for previous grants from the Swedish Research Council that have ended, final financial reports for all of these must have been submitted within the permitted time frame in order for you to apply for a new grant. Please contact your administrating organisation if you are unsure whether all your final reports have been submitted.

What applies for applications to or grants from other funding bodies?

If your application to the Swedish Research Council relates to the same project concept as a grant you have already been awarded by, or are applying for to, another funding body, please describe this.

Participating researchers

Participating researchers are other researchers with a doctoral degree or equivalent competence (not doctoral students), whose competence will be crucial for implementing the planned research. They do not have to be employed by a Swedish HEI. In total, the application must include researchers from at least 4 regions (including you as applicant), unless the application relates to national highly specialised healthcare or diseases that are only relevant for a few regions.

In Step 1, you must describe your planned participating researchers and other collaborating partners and their roles in the research plan (see instructions under “Research plan” below). However, you cannot invite the participating researchers in PRISMA in this step.

In Step 2 (full application), you must include a minimum of 3 and maximum of 10 participating researchers in your application. They shall be invited and shall themselves provide the necessary information themselves in Prisma, and upload these to the application. Any doctoral students and other collaboration partners and their roles shall be described in the research plan (please see instructions under “Research plan” below).

Costs and grant amounts

You can apply for a grant for all types of project-related costs, such as

  • salaries (including your own salary), however no more than corresponding to the person’s activity level in the project
  • premises
  • running costs (such as consumables, travel including stays at research facilities, publication costs, and minor equipment)
  • depreciation costs.

The grant amount includes cover of indirect costs as a percentage of the direct costs, according to the model used by your administrating organisation. Grants must not be used for scholarships. If a doctoral student participates, project funds may not be paid out as salary during teaching or other departmental duties. Only additional costs in conjunction with this clinical study are covered by the grant, not other healthcare costs.

The minimum amount you may apply for is 1 000 000 SEK per year, including indirect costs. The maximum amount you may be awarded is 20 000 000 SEK in total for 4 years.

The Swedish Research Council assumes that the administrating organisation will be responsible for covering any costs for implementing the project over and above this grant for a clinical study in therapy research.

Grant period

The grant period is 4 years, starting in January 2025. The first payment will be made during January 2025 at the earliest.

National collaboration

National collaboration is important and a requirement for applications for this grant. The collaboration shall be based on an actual need, for example to ensure access to a sufficiently large patient sample. Other needs for collaboration may relate to access to high-quality data sources, equipment or specialist competency within several disciplines. Collaboration can also be important for ensuring the study and its results have an impact. The requirement for national collaboration is achieved through active patient recruitment and participating researchers in a minimum of 4 regions. In addition, collaboration can also include universities and collaboration with companies in the medical sector that are active in Sweden.

The requirement for collaboration between a minimum of 4 regions must be fulfilled, unless there are special circumstances. Such special reasons may be that the application relates to national highly specialised healthcare/ according to the National Board of Health and Welfare, or to diseases that are relevant to only a few regions. If so, this shall be stated in the application.

User participation

User participation is necessary to ensure that the selection of research problem, overall purpose, primary outcome variable, and other outcome variables for the study take into account users’ viewpoints, and also their expressed wishes and needs. For this reason, you must describe clearly how user participation is ensured.

In addition to patient groups, the concept of user participation shall include patient organisations, relatives and others who may benefit from the results of the research.

What must the application contain? (Step 1)

Please refer to the application form in Prisma in parallel with reading the instructions below, which describe the call-specific content of the application. More information on what to do in practical terms is available in our Guide for applicants.

International experts are involved in the scientific assessment of the applications. To ensure fair and equitable assessment and efficient processing, please therefore complete your application in English, apart from the popular science description, which you must write in Swedish.

The information we request under each tab in the application form is described below.

Descriptive information

Abstract

In the abstract, please describe in brief the following:

  • what is to be done: purpose and aim
  • how the research problem will be studied in a summary project design, including patient sample, choice of variables, primary and secondary outcome measures, data collection and analysis methods, and also time plan. You are encouraged to use PICO (population/intervention/control/outcome)
  • the expected direct patient benefit from the result of the planned research.

The abstract shall provide a summary picture of the purpose and implementation of the research. Please use wording to ensure persons with another subject specialisation can understand the information.

The description may cover a maximum of 1 500 characters including blank spaces. This is approximately one third of an A4 page in Arial, font size 11, single line spacing.

Popular science description

Describe the planned research in such a way that a person who is not a researcher can understand it. Do this by answering the following questions:

  • What is the research about?
  • Why is it important to research this?
  • In what way may the new knowledge be important?

The popular science description is important when we inform about the research funded by the Swedish Research Council.

The text must be in Swedish and may cover a maximum of 2 000 characters including blank spaces. This is approximately half an A4 page in Arial, font size 11, single line spacing.

Other applications or grants

Describe briefly the different projects and their relationship if

  • you are applying for or intend to apply for other grants from the Swedish Research Council
  • you are receiving an ongoing grant from the Swedish Research Council with a grant period that wholly or partly overlaps the grant you are now applying for
  • there are applications or grants relating to the same project concept/purpose with the Swedish Research Council or other funding bodies (from you or another researcher).

In all cases, you should also justify why you are submitting one or several further applications. If there are no other applications or grants, please state so.

The description may cover a maximum of 2 000 characters including blank spaces. This is approximately half an A4 page in Arial, font size 11, single line spacing.

Report on/description of previously awarded grants for a clinical study in therapy research

If you are or have been the project leader for a clinical study grant (not planning grant) in the field of therapy research from the Swedish Research Council, you must submit a report describing the progress of the project.

Please state the project name, case number, grant amount and grant period (that is the payment period from the Swedish Research Council; the remaining availability period shall not be included) for the previous project.

Please describe the following:

  • The result of the previously awarded grant. If possible, reference a scientific publication.
  • How does the current project differ from the previously awarded grant?

The description may cover a maximum of 4 000 characters including blank spaces. This is approximately one A4 page in Arial, font size 11, single line spacing.

Clinical position

Describe in what way you fulfil the requirement for clinical position in Sweden and what your clinical work involves. The description may cover a maximum of 750 characters including blank spaces in Arial, font size 11, single line spacing.

Research description

Ethical aspects

Legal and formal requirements

State whether the research covers the handling of personal data, experiments on animals and/or studies involving humans.

You must also describe/state all approvals and permits that your therapy research project requires (such as from the Swedish Ethical Review Authority and the Medical Products Agency), and how you plan to obtain these. Describe any other permits that affect your application, such as whether parts of the research will be done in a country other than Sweden.

The description may cover a maximum of 2 000 characters including blank spaces. This is approximately half an A4 page in Arial, font size 11, single line spacing.

More information is available on the page Conducting ethical research.

Ethical considerations

Reflect on the ethical issues that may arise for your project, and describe these. You must also describe how you plan to address ethical dilemmas that may arise. Please justify why the research should be carried out against the background of the ethical issues you have identified. Examples of issues to reflect on:

  • How do your research questions and expected results measure up in relation to the ethical issues?
  • What (direct) risks (physical, mental, or integrity) will research persons or animals be exposed to?
  • What long-term risks may arise from the research? Is there any risk that the research may be used in a way that is detrimental to animals, nature/the environment, or society (whole or parts of the same) in other respects?
  • Is the research expected to contribute to other values over and above the knowledge gain? If so, to whom?
  • How do you weigh up the risks (in particular short-term risks) against the value (which is often more long-term) of the research?

If no ethical issues are raised, please justify this. The description may cover a maximum of 2 000 characters including blank spaces. This is approximately half an A4 page in Arial, font size 11, single line spacing.

Sex and gender perspectives

Please state whether sex and gender perspectives are applicable in your planned research, and justify your decision. Please note that we are not asking for information about the composition of the research team (women/men). Read more about sex and gender perspectives in research content.

The following applies:

  • If you answer “Yes”: Please justify your answer, and describe also how you take account of sex and gender perspectives in the research plan. If you have stated that sex and gender perspectives are applicable, but still choose not to include them in your research plan, you will need to justify this here.
  • If you answer “No”: Please justify your answer.

The justification may cover a maximum of 2 000 characters including blank spaces. This is approximately half an A4 page in Arial, font size 11, single line spacing.

Research plan

The research plan in Step 1 shall be forward-looking and consist of a brief but sufficiently clear description that the feasibility of the planned clinical study can be assessed. It may cover a maximum of 4 page-numbered A4 pages in Arial, font size 11, single line spacing and 2.5 cm margins, including references and any images.

The research plan must include the following headings and information, listed in the following order:

Purpose and aims

State the overall purpose and specific aims of the research project, and provide background information and justification for the project. Clarify the primary research question and the primary outcome variable, which must be clinically relevant.

Survey of the field

Summarise the current clinical knowledge and clinical practice of the research field. This includes what is known, any identified knowledge gaps, and what is in progress (for example, describe any ongoing clinical studies). State in what way the planned study continues to build on already existing knowledge and research (such as a completed pilot study). For entirely new interventions, you should summarise the research that justifies this clinical study. The field survey shall cover maximum half an A4 page.

Study design

The application must show how the study design and the statistical analysis enable answers to the study’s primary question.

The study design must include the following information under separate headings, listed in the following order:

  • Research questions: Structure the purpose of the research into questions. What is to be studied, and in whom? This should include a summary description of the research population, the method to be studied, controls, and outcomes. The research question should be described according to PICO (Population/Intervention/Control/Outcome). If PICO cannot be used, you must justify this. Specify the primary outcome and any important secondary outcomes of each research question.
  • Variables and measures: Describe in the first instance the variables that are relevant for the description and analysis of the primary outcome (main, background, explanatory variables). Describe the scale type and unit, and the way in which these will be measured/registered. Variables relating to secondary outcomes can be described in less detail.
  • Material: Patient selection – population, sample: Define the population the study result will be generalised to, including its size. Describe how patients will be selected from the underlying population. State the inclusion and exclusion criteria for patient selection in the study/sub-studies, the randomising procedure where relevant, and any other important design aspects, such as blinding.
  • Estimated sample size and power: If the study size is based on an assumption about treatment effect, you must justify this assumption. If not, state the smallest detectable treatment effect for the study’s primary outcome for the chosen study size, and the clinical relevance of this treatment effect. State and compensate for the expected drop-out rate. State the method of power calculation or alternatively effect calculation (reference to software or website), and also all assumptions and parameters the calculation is based on. The description shall be at such a level of detail that the calculation can be reproduced.
  • Statistical methods: The primary question shall be linked to a statistical analysis plan that is directly related to the study design and research question. Describe in detail the model that will be used in the primary analysis. Please note that this should be the same statistical model as the one used to calculate the study size. If there is any discrepancy, this must be clearly justified, and the differences and their consequences be described. Describe variables included, their type, and methods for managing dependent observations. Describe the methods for handling missing data, confoundingcontrol, and other relevant aspects of the primary analysis (such as the analysis set). Describe the primary approximation from the model. For secondary/other analyses, describe the statistical methods in general. Specify the responsible statistician in the project.
  • Feasibility:
    • Describe the competences and roles of yourself and the other researchers, and how these contribute to the execution of the project and your allocation of responsibilities. Describe your prior experience of conducting and leading clinical studies in therapy research, as well as the participating researchers’ experience of this. Explain in particular how the time allocated by you (that is, your activity level) as project leader is suitable for the task, including the relationship with your other clinical work and research undertakings.
    • Describe other key competences in the project organisation (for example study coordinator, statistician, data manager, quality controller/monitor) and their previous experience of conducting clinical studies, in particular studies of the type relevant for the current application.
    • Describe your formal competence concerning regulatory frameworks (GCP, GDPR, and so on) and support for legal and contract management for the planned project.
    • Describe the data sources used in the project, how data collection will be performed, and how protection of sensitive personal data is safeguarded.
    • State the prevalence for the population the study results will be generalised for (and the source of this information), as well as the size of the population you intend to study (based on inclusion and exclusion criteria) and any expected drop-out. For intervention studies, state specifically how large a proportion of the available population (that fulfil the inclusion and exclusion criteria) are expected to be included in the study.
    • For intervention studies, describe whether the study intervention is already available or planned for production, such as study drug and/or placebo, or medical devices.
  • Time plan: Describe the time plan for the study during the grant period (from start to conclusion). The level of detail shall be such that the feasibility of the study is clearly shown and can easily be assessed. Critical elements, milestones and similar shall be included. The time plan shall also describe the recruitment basis per year for prospective studies.
  • Risk mitigation: Identify and describe risks or obstacles that may affect the start-up and execution of the project (for example relating to permits and/or approvals, access to study medicines, or recruitment of patients) and your plan for managing them.
  • References: State references, but limit them to maximum half an A4 page.

Provide the following information also. If a heading is not relevant to your application, please state this under the heading.

Equipment:

Describe the basic equipment you and your team have at your disposal for the project.

Need for research infrastructure:

Specify the project’s need for international and national research infrastructure. In the first instance, you should use the research infrastructures supported by the Swedish Research Council, which are open to all. If you choose to use other infrastructure instead, please justify this need (also applies for local research infrastructure).

Call-specific information

Clinical benefit and health economic considerations

Describe how the project results – in terms of direct patient benefit – are expected to come into practical clinical use within a relatively short period of time (within 5 years of the completion of the project). Specify and explain in which way the results are being requested by patients and other stakeholders. Factors such as prevalence, the severity of the disease, and the cost to society shall be weighed into the description of clinical benefit.

Describe how the project results may contribute to better use of resources within health and medical care, and any potential gain for society as a whole. Discuss the possible health economic considerations that the project results may lead to.

The description may cover a maximum of 2 000 characters including blank spaces. This is approximately half an A4 page in Arial, font size 11, single line spacing.

User participation

Describe how user participation is ensured at the concept stage, in the planning and execution of the study, and in the implementation of the study result. If you or anyone else has prioritised among existing gaps in knowledge within the area with the help of user participation, on the basis that the knowledge gaps are important and relevant to users, please describe this process and its result.

The description may cover a maximum of 2 000 characters including blank spaces. This is approximately half an A4 page in Arial, font size 11, single line spacing.

Implementation

Describe how the result of the proposed research may be utilised by being implemented in health and medical care. Include a clear level structure and a time plan for implementation. State also the clinical effect goals that may be used to measure implementation.

The description may cover a maximum of 2 000 characters including blank spaces. This is approximately half an A4 page in Arial, font size 11, single line spacing.

National collaboration

Describe the positive effects the collaboration may lead to. They may, for example, be specialist competences in several disciplines, safeguarding a sufficiently large patient sample, or access to data or other equipment. Describe the regions, participating researchers or other key persons, and any companies that will be collaborating in the project. Describe also any collaboration with foreign equivalents. If there are special reasons why the requirement for collaboration including a minimum of 4 regions, i e your application only relating to national highly specialised care, or diseases that only are relevant for a few regions, you must state these.

The description may cover a maximum of 2 000 characters including blank spaces. This is approximately half an A4 page in Arial, font size 11, single line spacing.

State the number of Swedish regions that are contributing to patient recruitment and the names of the participating regions in the separate text fields in the application form. Please make sure the number of regions corresponds to the number of names selected for participating regions.

Description of merits

Describe how the merits you state in your CV and list of publications and other research outputs confirm your competence as project leader and scientifically responsible for implementing the proposed study in clinical therapy research. The description may cover a maximum of 2 000 characters including blank spaces. This is approximately half an A4 page in Arial, font size 11, single line spacing.

Publications and other research outputs

The applicant’s publications and other research outputs

Please attach your list drawn up according to the headings and information below. The list may cover a maximum of 5 page-numbered A4 pages in Arial, font size 11, single line spacing and 2.5 cm margins.

Sort the outputs under each heading in reverse chronological order, so that the latest publication is at the top of the list. Please only include articles or equivalent that are published or accepted for publication at the time of applying. The author name order shall be identical to that of the published work. You cannot supplement the application with outputs after the deadline for the call.

1. Selection of research outputs

List the 10 publications or other outputs that are the most important for confirming your competence as project leader and scientifically responsible for implementing the proposed clinical study in therapy research Describe how you contributed to each output, and its relevance to the research project described (maximum 4 lines per output). Highlight your name in bold in the author list/corresponding.

2. Relevant peer-reviewed research outputs from 2016–2024

In this part, the outputs listed under Item 1 shall also be included if they were published during the period in question. Sort them with your name highlighted in bold in the author list/corresponding under headings (type of output) in the following order:

  • Original articles
  • Conference contributions, the results of which are not included in other publications
  • Edited volumes
  • Research review articles
  • Books and book chapters
  • Other outputs that do not fit under any of the headings above. Please note that intellectual property rights shall be shown in the CV section of the application.
3. Relevant non peer-reviewed research outputs from 2016–2024

In this part, the outputs listed under Item 1 shall also be included if they were published during the period in question. Sort them with your name highlighted in bold in the author list/corresponding under the respective headings (type of output) in the following order:

  • Publications including popular science books/presentations
  • Preprints
  • Other outputs that do not fit under any of the headings above Please note that intellectual property rights shall be shown in the CV section of the application.

Budget and research resources

Amount applied for

Please state the amount per year applied for. The amount applied for will be shown under “Operating costs” in the table summarising the overall cost of the project.

Justification of the budget applied for

Justify briefly each cost applied for in your budget. You must clearly show the costs for which you are applying for funding from the Swedish Research Council, and the costs that may be covered via other grants awarded. Only additional costs in conjunction with clinical studies are covered by the grant, not other medical care costs. If the study drug/intervention to be trialled in the study is patented by a company, please state why the company is not financing the study.

The description may cover a maximum of 4 000 characters including blank spaces. This is approximately one A4 page in Arial, font size 11, single line spacing.

Other funding

Please state your or any other researcher’s funding for the project over and above what is applied for in this application. Please state the amounts in Swedish krona, rounded to the nearest 1 000 SEK.

Administrating organisation

Please state the administrating organisation and project site.

Review panels

Please request the review panel or panels (in priority order) that you wish to carry out the scientific assessment of your application.

The final allocation of applications is determined by the Swedish Research Council.

Review panels

Participants

Here you may invite participating administrators to your application. Please note that participating researchers cannot be invited to the application in Step 1.

CV

Under this tab, please upload your relevant CV information from your personal account in Prisma. The information/merits shall confirm your competence as project leader and scientifically responsible for implementing the proposed study in clinical therapy research.

The following information (where available) must always be included in your CV:

Education:

First, second and third cycle higher education and specialist degrees.

Work

  • Current employment (including information on employment format)
  • Longer relevant employment
  • Post-doctoral visits (state also as employing if applicable)
  • Researcher exchanges of relevance to the research described
  • Any longer interruptions in the research that have impacted on your opportunity to gain merit as a researcher.

Merits and awards

  • Docentship/associate professorship
  • Persons you have supervised (postdoctoral and doctoral students; state the number of persons in each category and list the names of the maximum 10 most relevant)
  • Relevant grants you have received in competition (list maximum 10)
  • Your most relevant prizes and awards (list maximum 10)
  • Any other merits of relevance to the application, such as experience of leading clinical studies/trials in clinical therapy research, invitations to lecture, leadership assignments, representative assignments, membership of scientific associations, and similar.

Intellectual property rights:

For example, patents and open access computer programs developed by you; state up to 10 of your most relevant.

What must the application contain? (Step 2)

Please refer to the application form in Prisma in parallel with reading the instructions below, which describe the call-specific content of the application. More information on what to do in practical terms is available in our Guide for applicants.

International experts are involved in the scientific assessment of the applications. To ensure fair and equitable assessment and efficient processing, please therefore complete your application in English, apart from the popular science description, which you must write in Swedish.

The information we request under each tab in the application form is described below.

Descriptive information

Abstract

In the abstract, please describe in brief the following:

  • what is to be done: purpose and aim
  • how the research problem will be studied in a summary project design, including patient sample, choice of variables, primary and secondary outcome measures, data collection and analysis methods, and also time plan. You are encouraged to use PICO (population/intervention/control/outcome)
  • the direct patient benefit from the planned research.

The abstract shall provide a summary picture of the purpose and implementation of the research. Please use wording to ensure persons with another subject specialisation can understand the information.

The description may cover a maximum of 1 500 characters including blank spaces. This is approximately one third of an A4 page in Arial, font size 11, single line spacing.

Popular science description

Describe the planned research in such a way that a person who is not a researcher can understand it. Do this by answering the following questions:

  • What is the research about?
  • Why is it important to research this?
  • In what way may the new knowledge be important?

The popular science description is important when we inform about the research funded by the Swedish Research Council.

The text must be in Swedish and may cover a maximum of 2 000 characters including blank spaces. This is approximately half an A4 page in Arial, font size 11, single line spacing.

Other applications or grants

Describe briefly the different projects and their relationship if

  • you are applying for or intend to apply for other grants from the Swedish Research Council
  • you are receiving an ongoing grant from the Swedish Research Council with a grant period that wholly or partly overlaps the grant you are now applying for
  • there are applications or grants relating to the same project concept/purpose with the Swedish Research Council or other funding bodies (from you or another researcher).

In all cases, you should also justify why you are submitting one or several further applications. If there are no other applications or grants, please state so.

The description may cover a maximum of 2 000 characters including blank spaces. This is approximately half an A4 page in Arial, font size 11, single line spacing.

Research description

Ethical aspects

Legal and formal requirements

State whether the research covers the handling of personal data, experiments on animals and/or studies involving humans.

You must also describe/state all approvals and permits that your therapy research project requires (such as from the Swedish Ethical Review Authority and the Medical Products Agency), and how you plan to obtain these. Describe any other permits that affect your application, such as whether parts of the research will be done in a country other than Sweden.

The description may cover a maximum of 2 000 characters including blank spaces. This is approximately half an A4 page in Arial, font size 11, single line spacing.

Further information is available on the page Conducting ethical research.

Ethical considerations

Reflect on the ethical issues that may arise for your project, and describe these. You must also describe how you plan to address ethical dilemmas that may arise. Please justify why the research should be carried out against the background of the ethical issues you have identified. Examples of issues to reflect on:

  • How do your research questions and expected results measure up in relation to the ethical issues?
  • What (direct) risks (physical, mental, or integrity) will research persons or animals be exposed to?
  • What long-term risks may arise from the research? Is there any risk that the research may be used in a way that is detrimental to animals, nature/the environment, or society (whole or parts of the same) in other respects?
  • Is the research expected to contribute to other values over and above the knowledge gain? If so, to whom?
  • How do you weigh up the risks (in particular short-term risks) against the value (which is often more long-term) of the research?

If no ethical issues are raised, please justify this. The description may cover a maximum of 4 000 characters including blank spaces. This is approximately one A4 page in Arial, font size 11, single line spacing.

Sex and gender perspectives

Please state whether sex and gender perspectives are applicable in your planned research, and justify your decision. Please note that we are not asking for information about the composition of the research team (women/men). Read more about sex and gender perspectives in research content.

The following applies:

  • If you answer “Yes”: Please justify your answer, and describe also how your take account of sex and gender perspectives in the research plan. If you have stated that sex and gender perspectives are applicable, but still choose not to include them in your research plan, you will need to justify this here.
  • If you answer “No”: Please justify your answer.

The justification may cover a maximum of 4 000 characters including blank spaces. This is approximately one A4 page in Arial, font size 11, single line spacing.

Research plan

The research plan in Step 2 shall be forward-looking and consist of a brief but complete description of the research task. It may cover a maximum of 10 page-numbered A4 pages in Arial, font size 11, single line spacing and 2.5 cm margins, including references and any images.

The research plan must include the following headings and information, listed in the following order:

Purpose and aims

State the overall purpose and specific aims of the research project, and provide background information and justification for the project. Clarify the primary research question and the primary outcome variable, which must be clinically relevant.

Survey of the field

Summarise the current clinical knowledge and clinical practice of the research field. This includes what is known, any identified knowledge gaps, and what is in progress (for example, describe any ongoing clinical studies). State in what way the planned study continues to build on already existing knowledge and research (such as a completed pilot study). For entirely new interventions, you should summarise the research that justifies this clinical study. The field survey shall cover a maximum of one A4 page.

Study design

The application must show how the study design and the statistical analysis enable answers to the study’s primary question.

The study design must include the following information under separate headings, listed in the following order:

  • Research questions: Structure the purpose of the research into questions. What is to be studied, and in whom? This should include a summary description of the research population, the method to be studied, controls, and outcomes. The research question should be described according to PICO (Population/Intervention/Control/Outcome). If PICO cannot be used, you must justify this. Specify the primary outcome and any important secondary outcomes of each research question.
  • Variables and measures: Describe in the first instance the variables that are relevant for the description and analysis of the primary outcome (main, background, explanatory variables). Describe the scale type and unit, and the way in which these will be measured/registered. Variables relating to secondary outcomes can be described in less detail.
  • Material: Patient selection – population, sample: Define the population the study result will be generalised to, including its size. Describe how patients will be selected from the underlying population. State the inclusion and exclusion criteria for patient selection in the study/sub-studies, the randomising procedure where relevant, and any other important design aspects, such as blinding.
  • Estimated sample size and power: If the study size is based on an assumption about treatment effect, you must justify this assumption. If not, state the smallest detectable therapy effect for the study’s primary outcome for the chosen study size, and the clinical relevance of this treatment effect. State and compensate for the expected drop-out rate. State the method of power calculation or alternatively effect calculation (reference to software or website), and also all assumptions and parameters the calculation is based on. The description shall be at such a level of detail that the calculation can be reproduced.
  • Statistical methods: The primary question shall be linked to a statistical analysis plan that is directly related to the study design and research question. Describe in detail the model that will be used in the primary analysis. Please note that this should be the same statistical model as the one used to calculate the study size. If there is any discrepancy, this must be clearly justified, and the differences and their consequences be described. Describe variables included, their type, and methods for managing dependent observations. Describe the methods for handling missing data, confoundingcontrol, and other relevant aspects of the primary analysis (such as the analysis set). Describe the primary approximation from the model. For secondary/other analyses, describe the statistical methods in general. Specify the responsible statistician in the project.
  • Feasibility
    • Describe the competences and roles of yourself and the other researchers, and how these contribute to the execution of the project and your allocation of responsibility. Describe your prior experience of conducting and leading clinical studies in therapy research, as well as the participating researchers’ experience of this. Explain in particular how the time allocated by you (that is, your activity level) as project leader is suitable for the task, including the relationship with your other clinical work and research undertakings.
    • Describe other key competences in the project organisation (for example study coordinator, statistician, data manager, quality controller/monitor) and their previous experience of conducting clinical studies, in particular studies of the type relevant for the the current application.
    • Describe your formal competence concerning regulatory frameworks (GCP, GDPR,) and support for legal and contract management for the planned project.
    • Describe the data sources used in the project, how data collection will be performed, and how protection of sensitive personal data is safeguarded.
    • State the prevalence for the population the study results will be generalised for (and the source of this information), as well as the size of the population you intend to study (based on inclusion and exclusion criteria) and any expected drop-out. For intervention studies, state specifically how large a proportion of the available population (that fulfil the inclusion and exclusion criteria) are expected to be included in the study.
    • For intervention studies, describe whether the study intervention is already available or planned for production, such as study drug and/or placebo, or medical devices.
  • Time plan: Describe the time plan for the study during the grant period (from start to conclusion). The level of detail shall be such that the feasibility of the study is clearly shown and can easily be assessed. Critical elements, milestones and similar shall be included. The time plan shall also describe the recruitment basis per year for prospective studies.
  • Risk mitigation: Identify and describe risks or obstacles that may affect the start-up and execution of the project (for example relating to permits and/or approvals, access to study medicines, or recruitment of patients) and your plan for managing them.
  • References: State references, but limit them to maximum half an A4 page.

Provide the following information also. If a heading is not relevant to your application, please state this under the heading.

Equipment

Describe the basic equipment you and your team have at your disposal for the project.

Need for research infrastructure

Specify the project’s need for international and national research infrastructure. In the first instance, you should use the research infrastructures supported by the Swedish Research Council, which are open to all. If you choose to use other infrastructure instead, please justify this need (also applies for local research infrastructure).

Specific intermediary objectives

State any specific and relevant intermediate objectives to be reported back and evaluated 1, 2 and 3 years after the project start. The purpose of the evaluation is to ensure that the project is running as planned, for example that the time plan is kept to, that patients are recruited at the expected rate, and that the quality of the data material is sufficiently high. Examples of intermediate objectives can be the number of patients included and/or percentage of patients for whom complete base line data have been obtained (that is, actual sample size), and/or median follow-up time in the study.

The description may cover a maximum of 4 000 characters including blank spaces. This is approximately one A4 page in Arial, font size 11, single line spacing.

Justification for changing the outline application

State the changes you have made in Step 2, that is, to the full application, based on the feedback you received from the review panel in Step 1. If you have chosen not to make any suggested changes, please justify this. It is important that you as applicant respond to all feedback, even if this did not lead to any changes to the application. Describe also any other changes you have made, and explain why.

The description may cover a maximum of 4 000 characters including blank spaces. This is approximately one A4 page in Arial, font size 11, single line spacing.

Call-specific information

Clinical benefit and health economic considerations

Describe how the project results – in terms of direct patient benefit – are expected to come into practical clinical use within a relatively short period of time (within 5 years of the completion of the project). Specify and explain in which way the results are being requested by patients and other stakeholders. Factors such as prevalence, the severity of the disease, and the cost to society shall be weighed into the description of clinical benefit.

Describe how the project results may contribute to better use of resources within health and medical care, and any potential gain for society as a whole. Discuss the possible health economic considerations that the project results may lead to.

The description may cover a maximum of 4 000 characters including blank spaces. This is approximately one A4 page in Arial, font size 11, single line spacing.

User participation

Describe how user participation is ensured at the concept stage, in the planning and execution of the study, and in the implementation of the study result. If you or anyone else has prioritised among existing gaps in knowledge within the area with the help of user participation, on the basis that the knowledge gaps are important and relevant to users, please describe this process and its result.

The description may cover a maximum of 4 000 characters including blank spaces. This is approximately one A4 page in Arial, font size 11, single line spacing.

Implementation

Describe how the result of the proposed research may be utilised by being implemented in health and medical care. Include a clear level structure and a time plan for implementation. State also the clinical effect goals that may be used to measure implementation.

The description may cover a maximum of 4 000 characters including blank spaces. This is approximately one A4 page in Arial, font size 11, single line spacing.

National collaboration

Describe the positive effects the collaboration may lead to. They may, for example, be specialist competences in several disciplines, safeguarding a sufficiently large patient sample, or access to data or other equipment. Describe the regions, participating researchers or other key persons, and any companies that will be collaborating in the project. Describe also any collaboration with foreign equivalents. If there are special reasons why the requirement for collaboration including a minimum of 4 regions, such as your application only relating to national highly specialised care, or diseases that only are relevant for a few regions, you must state these.

The description may cover a maximum of 4 000 characters including blank spaces. This is approximately one A4 page in Arial, font size 11, single line spacing.

Please state the number of Swedish regions that are contributing to patient recruitment and the names of the participating regions in the separate text fields in the application form. Please make sure the number of regions corresponds to the number of names selected for participating regions.

Description of merits

Describe how the merits you state in your CV and list of publications and other research outputs confirm your competence as project leader and scientifically responsible for implementing the proposed study in clinical therapy research. The description may cover a maximum of 2 000 characters including blank spaces. This is approximately half an A4 page in Arial, font size 11, single line spacing.

Publications and other research outputs

The applicant’s publications and other research outputs

Please attach your list drawn up according to the headings and information below. The list may cover a maximum of 5 page-numbered A4 pages in Arial, font size 11, single line spacing and 2.5 cm margins.

Sort the outputs under each heading in reverse chronological order, so that the latest publication is at the top of the list. Please only include articles or equivalent that are published or accepted for publication at the time of applying. The author name order shall be identical to that of the published work. You cannot supplement the application with outputs after the deadline for the call.

1. Selection of research outputs

Lista de 10 publications or other outputs that are the most important for confirming your competence as project leader and scientifically responsible for implementing the proposed clinical study in therapy research. Describe how you contributed to each output, and its relevance to the research project described (maximum 4 lines per output). Highlight your name in bold in the author list/corresponding.

2. Relevant peer-reviewed research outputs from 2016–2024

In this part, the outputs listed under Item 1 shall also be included if they were published during the period in question. Sort them with your name highlighted in bold in the author list/corresponding under headings (type of output) in the following order:

  • Original articles
  • Conference contributions, the results of which are not included in other publications
  • Edited volumes
  • Research review articles
  • Books and book chapters
  • Other outputs that do not fit under any of the headings above Please note that intellectual property rights shall be shown in the CV section of the application.
3. Relevant non peer-reviewed research outputs from 2016–2024.

In this part, the outputs listed under Item 1 shall also be included if they were published during the period in question. Sort them with your name highlighted in bold in the author list/corresponding under the respective headings (type of output) in the following order:

  • Publications including popular science books/presentations
  • Preprints
  • Other outputs that do not fit under any of the headings above Please note that intellectual property rights shall be shown in the CV section of the application.

Participating researchers’ publications and other research outputs

Attach all participating researchers’ publication lists joined together into a single file.

The list for each researcher shall include the 10 publications or other research outputs that are the most relevant for the implementation of the research activities described, and shall cover a maximum of 1 A4 page in Arial, font size 11, single line spacing and 2.5 cm margins. The name of the researcher in question shall be highlighted in bold and also be included in the page header of each list.

The outputs may be of the following types and must be published or accepted for publication at the time of applying. The author name order shall be identical to that of the published work. The application cannot be supplemented with publications after the deadline for the call.

Peer-reviewed:

  • original articles
  • conference contributions
  • edited volumes
  • research review articles
  • books and book chapters
  • other outputs

and

Non peer-reviewed research outputs

Budget and research resources

Project personnel

State the activity level (per cent of a full-time equivalent) of all personnel active in the project, that is, you, any other researchers, doctoral students and other personnel. Please also state the salary you are applying for, for yourself and/or other personnel in the project, both as a percentage of a full-time salary and as actual annual amounts (including social security contributions). Please state the amounts in Swedish krona, rounded to the nearest 1 000 SEK. If there are major differences in the salary costs for different years, please explain this in the budget justification.

Other costs

Describe any other costs of the project (premises costs, operating costs including travel costs and depreciation costs). State annual amounts in Swedish krona, rounded to the nearest 1 000 SEK. You may include depreciation costs for equipment to be used in the project, provided that

  • the equipment has an economic life of at least three years
  • the equipment has an acquisition value above a certain amount
  • the need cannot be satisfied through use of national or international infrastructure supported by the Swedish Research Council and thereby open to all.

You may only include the proportion of depreciation costs that corresponds to the use of the equipment in the proposed project, and you may not include depreciation costs for equipment that is wholly funded by other grants. Please contact your administrating organisation for information about what is included in local research infrastructure, acquisition values or how to calculate depreciation costs.

Total cost of the project

Prisma will automatically add up your budget items in a table. The total amount you are applying for shall also include indirect costs. You will have to add these to the table yourself. Here you can also add any additional costs that the project entails (for which you are not seeking funding under this call).

Indirect costs follow the model that your administrating organisation uses. Please contact your administrating organisation if you have any questions about what constitutes indirect and direct costs.

Justification of the budget applied for

Justify briefly each cost applied for in your budget. Clarify, for example, how salary costs, indirect costs, and monitoring costs have been calculated (number of physical visits, number of hours, etc.),

You must clearly show the costs for which you are applying for funding from the Swedish Research Council, and the costs that may be covered via other grants awarded. Only additional costs in conjunction with clinical studies are covered by the grant, not other medical care costs. If the study drug/intervention to be trialled in the study is patented by a company, please state why the company is not financing the study.

The description may cover a maximum of 4 000 characters including blank spaces. This is approximately one A4 page in Arial, font size 11, single line spacing.

Other funding

Please state your or any other participating researcher’s funding for the project over and above what is applied for in this application. Please state the amounts in Swedish krona, rounded to the nearest 1 000 SEK.

Administrating organisation

Please state the administrating organisation and project site.

Participants

Under this tab, you shall invite the participating researchers and any participating administrators to your application.

CV

Under this tab, please upload your relevant CV information from your personal account in Prisma. The information/merits shall confirm your competence as project leader and scientifically responsible for implementing the proposed study in clinical therapy research. Participating researchers must upload their own CV information to the application.

The following information (where available) must always be included in each CV:

Education

First, second and third cycle higher education and specialist degrees.

Work

  • Current employment (including information on employment format)
  • Longer relevant employment
  • Post-doctoral visits (state also as employing if applicable)
  • Researcher exchanges of relevance to the research described
  • Any longer interruptions in the research that have impacted on your opportunity to gain merit as a researcher.

Merits and awards

  • Docentship/associate professorship
  • Persons you have supervised (postdoctoral and doctoral students; state the number of persons in each category and list the names of the maximum 10 most relevant)
  • Relevant grants you have received in competition (list maximum 10)
  • Your most relevant prizes and awards (list maximum 10)
  • Any other merits of relevance to the application, such as experience of leading clinical studies/trials in clinical therapy research, invitations to lecture, leadership assignments, representative assignments, membership of scientific associations, and similar.

Intellectual property rights:

For example, patents and open access computer programs developed by you; state up to 10 of your most relevant.

How your application is assessed

Scientific quality is the fundamental criterion when the Swedish Research Council allocates grants to research. Your application is evaluated in competition with the other applications on the basis of the following evaluation criteria.

Evaluation process

Your application for Grant for clinical study within therapy research is evaluated in one of the three review panels where the members are international researchers.

At least three members review and grade your application individually. If extra competence is needed, your application might also be evaluated by an additional, external, reviewer. The panels also include specific experts on statistics that contribute to the assessment of the statistical parts of the application. A representative from patient organisations complements the panel for appraisal on patient value and benefit for the society. The entire review panel (not including any external reviewers) then meets at a review panel meeting to discuss and prioritise the applications, and to make a proposal for a decision to the Committee for Clinical Therapy Research.

Review panels

For Grant for clinical study within therapy research, a two-step procedure is used. In the first step, you as applicant submit an outline application for evaluation. All applications in step 1 receive a final statement.

Applications recommended to proceed to step 2 will be invited to submit a full application.

Following the grant decision all applications in step 2 will receive an individual final statement containing the grades and a summary of the review panel’s discussion and overall assessment of the scientific quality of the application

Here you will find a more comprehensive description of the Swedish Research Council's assessment of applications.

Evaluation criteria and guiding questions

The evaluation of the scientific quality of your application is made based on four basic criteria (Scientific quality of the proposed research, Novelty and originality, Merits of the applicant, Feasibility). The purpose of using several components is to achieve a multi-faceted evaluation. The criteria are assessed on a seven-grade scale, except for feasibility, which is assessed on a three-grade scale. In addition to these basic criteria, your application is also evaluated using an additional criterion patient value and benefit for the society on a seven-grade scale.

For each criterion, there are guiding questions to support the panel members’ evaluation of your application. These can also function as guidance for you when you write your application.

Scientific quality of the proposed research (1–7)

Guiding questions:
  • Are the ethical considerations for the proposed project properly described and addressed? Does the applicant adequately consider risk/value/suffering for humans, nature and/or society?
  • Is the main research question(s) motivated and specified?
  • Is the project design adequate and described in accordance with the instructions? Would an alternative study design have increased efficiency?
  • Is the primary outcome(s) and endpoint(s) well defined and the most appropriate?
  • Are the variables and measurements/assessments, power calculations, sample size and patient selection convincingly described and are they linked to the research question and the study design?
  • Is the described national collaboration adequate and relevant in relation to the proposed study and the requirement in the call?
  • Have the applicants described if and how sex and gender are relevant to the research question?
    • If relevant, have the applicants considered sex and gender in their description of the proposed work, including choice of study population, design, analyses, and implementation?
    • If not relevant, have the applicants justified why this is the case?

Patient value and benefit for the society (1–7)

Guiding questions:
  • May the results of the study be directly implementable into clinical practice within a relatively near future (within 5 years after the end of the project)?
  • Have target groups (patient groups, patient organizations, significant others and others who may benefit from the research findings) been consulted in the planning of the study, when designing the primary and secondary outcome variables and the choice of endpoints? Are target groups involved in the continuation planning, evaluation and implementation of the study?
  • May the results of the study contribute to a significantly increased clinical benefits and/or less harms for the individual? Assessed clinical value can be influenced by prevalence, severity of the disease or social costs.
  • May the results of the study contribute to a better use of healthcare resources?

Novelty and originality (1–7)

Guiding questions:
  • Is there a need of more research in this area in accordance to existing systematic reviews, national and international guidelines and/or identified knowledge gaps?
  • Have similar studies been conducted before? If so, does the applicant describe why the proposed project is relevant?
  • Will the results of the project fill an existing knowledge gap in clinical practice?

Merits of the applicant(s) (1–7)

Guiding questions:
  • Do the applicant and the participating researchers have sufficient clinical research experience, expertise, and scientific network for performing the proposed project?
  • Based on previous publications and other scientific achievements, do the applicant and the participating researchers show a track record of high quality and ability to successfully disseminate research findings (focus should be given to the most relevant and important publications and reports with emphasis on quality rather than quantity)?
  • Is there appropriateness of the team of researchers, if applicable, in terms of availability and complementarities of all the relevant expertise, and in how the different roles and responsibilities are distinguished?
  • Do the applicant, and the participating researchers, have the experience, know-how and clinical resources to facilitate and conduct a clinical study?
  • Has the applicant and/or any of the participating researchers been involved in critical evaluation of clinical studies or guideline establishment?

Feasibility (1–3)

Guiding questions:
  • Does the applicant adequately consider relevant legal and formal requirements for the proposed research, such as ethical permits and guidelines?
  • Is the time schedule optimal to carry out the proposed project within the timeframe of four years plus one year of availability period, totally five years?
  • Is the team composition and its environment suitable for carrying out the proposed research?
    • Does the project include the availability and accessibility of relevant personnel, including statistician, legal support, equipment, facilities/infrastructures and other necessary resources?
    • Is there involvement of a clinical trials unit and/or skilled trial staff (if applicable)?
    • Are data sources, data collection, and responsibility for data management clearly described?
  • Is the recruitment of patients into the study feasible within the time frame of the project – e.g. is the size of the eligible population sufficient, have drop-outs and loss of enrollment in the recruitment due to holidays been taken into account?
  • Is the intervention (if applicable, e.g. study drug, placebo, or medtech device) readily available? If not, is development, production, approval and availability planned and secured?
  • Does the research plan include adequate identification and handling of project related risks and challenges, and plans to mitigate them?

Overall grade (1–7)

The above subsidiary criteria are weighed together into an overall grade, which reflects the review panel’s joint evaluation of the application’s scientific quality.

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