Grant for clinical studies within therapy research - outline application

Clinical Studies Sweden – regional nodes support the work with clinical studies

The collaboration Clinical Studies Sweden consists of six regional nodes, one in each collaboration region. The nodes can provide contacts with relevant regional resources, such as research units, quality register centres, biobanks and cancer centres. You can also access support via the nodes in the work with a clinical study, for example with

• study protocols, permit applications, data management and statistics
• infrastructures for implementation (such as trial units)
• training in clinical research methodology (such as GCP and statistics)
• expertise relating to statistics, epidemiology and health economics.

You can find more information about the nodes at Kliniskastudier.se External link, opens in new window.. This also includes a step-by-step guide External link, opens in new window. that describes the study process and what you need to consider when conducting a clinical study.

Practical tips and advice relating to register-based studies

At Registerforskning.se External link, opens in new window., there is 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.

The following requirements must be fulfilled in order 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 of relevance for this call are clinical therapy studies, aimed at producing reliable and implementable results that may be of benefit to patients and society within a relatively short period of time (within 5 years after completion of the project). 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 in clinical therapy research that has previously been funded by the Swedish Research Council.

Link to SBU’s interpretation and evaluation of a knowledge gap External link, opens in new window.

Applicant

The applicant for a grant for clinical studies within therapy research shall be an individual researcher. You shall be the project leader and have scientific responsibility for the project. 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.

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.

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).

Grants from the Swedish Research Council shall be administered by a Swedish HEI or another Swedish organisation that fulfils our criteria for administrating organisations Opens in new window.. Your organisation must therefore be approved as an administrating organisation for you to apply.

You do not have to be employed by the administrating organisation at the time of applying, 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

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 clinical studies within therapy research and project or career grants

You may apply for a grant for clinical studies 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 in clinical studies, this will be considered during the overall weighted assessment of the resource requirement.

Number of applications for grants for clinical studies within therapy research

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

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. Other restrictions on the grants you may apply for during the same year are shown in the table below.

Table: Grants you may apply for simultaneously Opens in new window.

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 where the grant period (payment period from the Swedish Research Council) overlaps the grant 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. Information about the criteria for your previous grant can be found in the “Approval of terms and conditions” you received from the Swedish Research Council.

If you have already been awarded a project or career grant

You may apply for this grant for clinical studies within therapy research if you are the project leader for an ongoing research project grant (however not if this is within the area of clinical therapy research) or career grant. A prerequisite for the application to be successful is that the grant awarded is not part of the application for a research environment grant, but on the other hand, the grant awarded may complement the application.

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 may not apply for a grant for clinical studies in therapy research. On the other hand, you may participate in such an application.

The table below shows information and other restrictions on the grants you may apply for if you already have an ongoing grant.

Table: Grants you may apply for if you have an ongoing grant Opens in new window.

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 idea as a grant you have already been awarded by, or are applying for to another funding body, please describe this.

Participating researchers

You cannot invite any participating researchers to this outline application. Please describe any collaborating partners and their roles under the heading “National collaboration” (see instructions under “Call-specific information” 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 clinical studies are covered by the grant, not other medical care 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 cover any costs in excess of the amount received.

Grant period

The grant period is 4 years, starting in January 2023. The first payment will be made during January 2023 at the earliest.

National collaboration

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

The requirement for collaboration between a minimum of 4 regions must be fulfilled, unless there are special circumstances. Such special reasons are that the application relates to national highly specialised care, or to diseases that are relevant to only a few regions. If so, this shall be stated in the application. Link to the National Board of Health and Welfare's overview of care areas within the process for national highly specialised care. External link, opens in new window.

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 the user 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.

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 Opens in new window..

Language

Foreign 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.

Sections of the application

The application form includes the following tabs:

• Descriptive information
• Research description
• Call-specific information
• Budget and research resources
• Publications
• Administrating organisation
• Review panels
• Participants (only administrators in this call)
• CV

The information we request under each tab 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 impact measurement, data collection and analysis methods, and also time plan. For intervention studies: please 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 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 text must be in Swedish and cover a maximum of 2 000 characters including blank spaces. The popular science description is important when we inform about the research funded by the Swedish Research Council.

Other applications or grants

Describe the relationship between the different projects 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 with the grant you are now applying for
• there are applications or grants relating to the same project concept/objective from 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 one half 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, or experiments on animals and/or studies involving humans.

If the research covers any of the above, you must also describe/state the approvals and permits your research project requires, and how you plan to obtain these. Describe any other permits that affect your application, for example if parts of the research will be done in a country other than Sweden. If no approvals or permits affect your application, please state this.

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

More information is available on the page “Ethical research” on the Swedish Research Council’s website Opens in new window.

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 how they will be managed. Please note that we are not asking for information about the composition of the research team (men/women). Read more about sex and gender perspectives in research content. Opens in new window.

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 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 shall be forward-looking and consist of a brief but complete description of the research task. It shall 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 brief background information and justification for the project. Clarify the primary 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, what is ongoing (ongoing clinical studies), and any identified knowledge gaps. State in what way the planned study continues to building on already existing knowledge and research. For entirely new interventions, a summary should be made of the research that justifies major clinical studies. The field survey shall cover maximum ½ A4 page.
• Study design: The application must show how the study design and the statistical analysis enables 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 question population (inclusion and exclusion criteria), the method to be studied, controls, and outcomes. The research question should be set up according to PICO (Population/Intervention/Control/Outcome). If PICO cannot be used for the research question, you must justify this. Specify the primary outcome of each research question, and any secondary outcomes as well.
  • Variables and measures: Describe how each variable (main, background, explanatory) will be measured/registered.
  • Material: Patient selection – population, sample Define the population the study result will be generalised to. Describe how patients will be selected from the underlying population. State the inclusion and exclusion criteria for patient selection in the study/sub-studies.
  • Estimated sample size and power: If the study size is based on an assumption about therapy effect, this assumption must be justified. If not, the least clinically relevant difference in therapy effect for the study’s primary outcome for the chosen study size shall be stated. The expected drop-out rate shall be stated, and be compensated for. The method of power calculation (or effect calculation) used shall be stated (reference to software or website), and also all assumptions and input parameters that the calculation is based on.
  • 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. Describe variables included, their form, and methods for managing dependent observations. Describe the methods for handling missing data, confounding , and other relevant aspects of the primary analysis. Describe the primary approximation from the model. For secondary/other analyses, describe the statistical methods in general. Specify the statistician responsible in the project.
  • Time plan: Describe the time plan for the study during the grant period. The time plan shall also describe the recruitment basis and annual recruitment rate.
  • References: Include references, but limit them to maximum ½ A4 page.
  • Project organisation: Describe the project organisation and the participating clinics/hospitals. Clarify the contributions of yourself and any other researchers and/or key persons to the implementation of the project, including a description of competences and roles in the project. 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 research undertakings. Describe how representatives of users/patients have participated in the trial planning and how they are involved in the various subsidiary steps, such as continuation planning, implementation and evaluation.
  • Risk management: Describe any crucial risks or obstacles that may impact on the implementation, and your plan for managing them.

Scientific report on previously awarded grants

If you are or have been the project leader for a research environment grant in the area of clinical therapy research, where the Swedish Research Council’s payment period for the funds awarded ends no later than December 2022, you must submit a report describing the progress of the project.

Please state the project name, registration 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:

• What did the previously awarded grants show?
• How does the current project differ from the previously awarded grant?

The description may cover a maximum of 8 000 characters including blank spaces. This is approximately two A4 pages in Arial, font size 11, single line spacing.

Call-specific information

Clinical benefit and health economics 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 economics considerations that the project results may lead to.

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.

User participation

Describe how user participation is ensured at the concept stage, planning stage, implementation stage, and dissemination stage. 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 1 500 characters including blank spaces. This is approximately one third of an A4 page in Arial, font size 11, single line spacing.

Implementation

Describe how the result of the proposed research can be utilised through 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 shall be used to measure implementation.

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.

National collaboration

State which Swedish regions, other researchers and companies will collaborate in the project. Describe also any collaboration with foreign equivalents. Describe the positive effects the collaboration may lead to. These may relate to factors such as ensuring a sufficiently large patient sample, access to high-quality data sources, equipment or specialist competency within several disciplines.

If there are special reasons why the requirement for collaboration including a minimum of 4 regions, you must state these.

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.

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.

Clinical work

Describe in what way you fulfil the requirement for clinical work in Sweden (see under the heading “Requirements for applicants”) 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.

Budget and research resources

The maximum amount you may apply for and be granted is 20 million SEK, including indirect costs. 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.

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 medicine/therapy 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 maximum 2 000 characters, including blank spaces. This is approximately one half 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.

Publications

Applicant’s publication list

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

Sort the publications 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. The application cannot be supplemented with publications after the deadline for the call.

1. Selection of publications: List the 10 publications of greatest importance to your application. Describe how you contributed to each publication, and its relevance to the research project described (maximum 4 lines per publication). Highlight your name in bold in the author list.

2. Relevant publications from 2014–2022: In this part, the publications listed under Item 1 shall also be included if they have been published during the period in question. Sort the publications, with your name highlighted in bold in the author list, under each heading (publication type) in the following order:

• Peer-reviewed original articles
• Peer-reviewed conference contributions, the results of which are not included in other publications
• Peer-reviewed edited volumes
• Research review articles
• Peer-reviewed books and book chapters
• Other publications including popular science books/presentations

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 Opens in new window.

Participants

Here you as applicant may invite participating administrators to your application. Please note that participating researchers may not be invited in this outline application.

CV

Under this tab, please upload your relevant CV information from your personal account in Prisma.

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 employment form) and longer relevant employment held, postdoctoral visits (also included as employment if relevant), research exchanges relevant to the research described and any longer interruptions in the research that have impacted on your opportunity to gain merit as a researcher.
• Merits and awards: Docentship/associate professorship, supervisees (postdoctoral and doctoral students; state the number of persons in each category and list the names of the up to 10 most relevant to you), up to 10 of your most relevant grants awarded in competition, up to 10 of your most relevant prizes and awards, and up to 20 other merits relevant to the application.
• Intellectual property rights: For example, patents and open access computer programs developed by you; state up to 10 of your most relevant.
• Other merits: Experience of leading clinical trials or similar.

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

For Grant for clinical studies within therapy research, a two-stage procedure is used. This means that you as applicant first submit an outline application for evaluation. Those applicants that are recommended will be invited to submit a full application. Your application for Grant for clinical studies within therapy research - outline application is evaluated by review panel where the members international researchers.

At least three members review and grade your application individually. The entire review panel then meets at a review panel meeting to discuss and prioritise the applications, and finally to make a proposal for a decision to the Committee for Clinical Therapy Research. All outline applications will receive an individual final statement that reflects the review panel’s discussion of the scientific quality of the application.

Review panels Opens in new window.

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

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, Patient Value, Novelty and originality, Merits of the applicant, Feasibility). The purpose of using several components is to achieve a multi-faceted evaluation. Only outline applications with high scientific quality and patient value will be recommended for full application submission. The criteria are assessed on a seven-grade scale, except for feasibility, which is assessed on a three-grade grade scale.

Considering the nature of clinical therapy research, Novelty and Feasibility will be weighted lower than the other criteria. The outline application will not be graded. The Review panel will perform an overall assessment of the five evaluation criteria and grade as followed:

• Prioritized and asked to submit a full application.
• Rejected

For the assessment of the full application a seven-grade scale is used for four of the assessment criteria: Scientific quality of the proposed research, Patient value – benefit of the research, Novelty and originality and Merit of the applicants. Feasibility is graded using a three-grade scale. The various criteria being used in the assessment will be weighed together to an overall grade (1—7), which reflects the overall assessment of the scientific quality of the application by the evaluation panel. Only applications that have been assessed to have high scientific quality and patient value will be consider for funding. 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, animals, nature and/or society?
• Is the main research question(s) motivated and specified?
• Is the primary outcome(s) and endpoint(s) well defined and the most appropriate?
• Is the project design adequately designed and in accordance with the instructions? Would an alternative study design have increased efficiency?
• 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 sex and gender is described as relevant to the research question, have the applicants considered sex and gender in their description of the proposed work, including choice of study population, design, analyses, and implementation?
• If sex and gender is not considered in the description of the proposed work, including choice of study population, design, analyses, and implementation, have the applicants justified why this is the case?

Patient value – 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?
• Will the results of the project fill an existing knowledge gap in the clinic?

Merits of the applicant (1–7)

Guiding questions:

• Do the team (applicant and the participating researchers) have sufficient research experience, expertise, and scientific network for performing the proposed project?
• Based on previous publications and other scientific achievements, does the team 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, 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 applicants and the team as a whole 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 recruitment of patients into the study feasible within the time frame of the project – have drop-outs and loss of enrollment in the recruitment due to holidays been taken into account?
• Does the project include the availability and accessibility of relevant personnel, including statistician, skills, equipment, facilities/ infrastructures and other necessary resources?
• Is the team composition and its environment suitable for carrying out the proposed research?
• Is there involvement of a clinical trials unit or any trial staff (if applicable)?
• Is it clear who is responsible for the data management?
• 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?
• Does the research plan include adequate identification and handling of risks and challenges?

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.

Report for previously awarded research grant

These guiding questions are only to be used for those project outlines where the project leader has earlier received a grant in Clinical Therapy Research. These questions should serve as guidance when assessing the preliminary scientific report for previously awarded research grant.

Guiding questions:

• What was the outcome of the previously awarded grant?
• In what way does the now presented outline differ from the previously awarded grant?