Grant for clinical studies within therapy research - full application

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 shall be clinical, that is, involve such medical and health sciences research that assumes the structures and resources of healthcare, and that has the goal of solving an ill health problem or identifying factors to lead to increased health. The research should aim to fill a knowledge gap. Research 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 in therapy research must be an individual researcher together with their organisation (a Swedish Higher Education Institution (HEI) or another Swedish organisation that fulfils our criteria for administrating organisations for Swedish Research Council grants Opens in new window.). We must have approved your organisation as an administrating organisation for you to apply. The administrating organisation must sign your application in Prisma no later than 7 calendar days after the deadline for this call.

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 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 applicants (project leaders).

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.

For other information, see the call text for the outline application. Opens in new window.

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

You must include a minimum of 3 and maximum of 10 participating researchers in your application. Participating researchers are other researchers with a doctoral degree or equivalent competence (not doctoral students) whose scientific competence will be crucial for the implementation of the planned research. They do not have to be employed by a Swedish HEI.

Participating researchers shall provide the necessary information themselves in Prisma, and upload these to the application. Any further collaborating 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, costs of permit applications or similar, 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 be related 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 may be 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.

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 patients, the concept of “user participation” also includes patient organisations, patient families 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

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.

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
• 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, 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 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 text must be in Swedish and 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. 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 current applications or grants with the same project concept/purpose at 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, 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, such as whether parts of the research will be done in a country other than Sweden. If no approvals or permits are needed, 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.

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

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 (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 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 brief background information and justification for the project. Specify the main research question and the primary endpoint, 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: Describe the design of each sub-study/question and justify why the proposed study design is the most suitable one for answering the question. For intervention studies, all therapies studied and compared shall be described in detail in terms of factors such as type(s) of therapy, dosage, follow-up periods, evaluation, etc. For intervention studies, please use PICO (population/intervention/control/outcome). For controlled cross-section studies, the therapy given to the control group shall also be described. Stating the standard therapy is not sufficient. Any differences between the therapy procedures of the participating clinics shall be clearly described. For cohort/observation studies, any confounders shall be identified and the treatment of these described. For cross-over studies, where the patient is their own control, the planning of the various therapy periods shall be described, and also how the risk of “carry-over” effect, etc., is taken into account. For longitudinal studies, the choice of repeat follow-up occasions shall be justified. It shall be clearly shown which follow-up occasion is related to the main outcome of the study. Equally detailed description of the data collection shall be provided for register-based studies when patient data is collected from one or several different registers. All outcomes shall be stated. For subjectively-based outcomes, such as PROMs (patient reported outcome measures), it is not sufficient to state the name of the questionnaires. It is important to take into account the fact that register data for the same outcome may have been registered using different types of measuring instruments/assessment forms, which result in non-comparable data.

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? Specify the primary outcome variable of each research question and the secondary outcome variables involved as well. In therapy effect studies, the effect variable (such as target value or percentage change to the primary outcome) shall also be specified. Justify any use of a surrogate endpoint.
• Variables and measures: Describe how each variable (main, background, explanatory) will be measured/registered and, in particular, in what format the measured values will be used in statistical description and analysis (for example as continuous, binary or categorical data, as differences, or as percentage changes). Compound variables (such as function, ability and quality of life) and qualitative variables (such as pain and satisfaction) are usually assessed using various types of forms and scales (such as questionnaires and rating scales). In such cases, the dimensions/variables used shall be stated, and also the type of response alternative (such as numerical, verbal categories, VAS), and the way in which the data collected is used shall be stated. Please include appropriate references to any questionnaires/rating scales.
• Material: Patient selection – population, sample. Define the population’s characteristics, and state the inclusion and exclusion criteria for patient selection in the study/sub-studies. Describe also how the participating clinics contribute to the patient selection. State how any differences in therapy procedures that could affect the study are handled. For register studies, any potential risk of systematic under or over-registration of patient groups shall be taken into account when defining inclusion and exclusion criteria. For randomised studies: Describe the randomisation approach, and specify who is responsible for the randomisation. Please also state for whom (patient, therapist, evaluator) the randomising is blind, and justify any exceptions.
• Estimated sample size and power: Explain and justify the smallest difference in treatment effect/primary outcome variable between control and treatment (or equivalent) to be clinically important to detect and estimate the sample size of the study/sub-studies thereafter. Calculate the power of the study for the planned sample size, taking account of estimated drop-outs, if possible based on previous own studies or studies by others. Describe also the estimated number of patients available for the study in the participating regions and clinical, and how this impacts on the dimensioning. If applicable, any planned multiple statistical tests and/or interim analysis shall also be taken into account in the dimensioning. Describe also, where applicable, how the patient compliance with the study will be monitored and/or taken into account.
• Statistical methods: Each research question should be linked to specified statistical methods that are based on the specified variable selection, the method for data collection and planned management of data for statistical description. The choice of statistical analysis (hypothesis testing) and/or modelling, quality assurance or similar shall be described. Verify that the proposed statistical approach is relevant for the question asked, and for the characteristics of the data material. It is not enough to use general concepts such as descriptive statistics, parametric and non-parametric methods or standard methods for analysis. Please note that the normal distribution could be a possible probability distribution for symmetric quantitative data, such as laboratory data, but never for data from assessments in questionnaires. Examples of other method issues that may have to be considered: How will dependent data be handled, for example within the group and/or between groups? Which statistical methods are planned for complex data from questionnaires and other subjective assessments, which are expected to generate ordered category data? How will longitudinal data and drop-outs be handled? What are the criteria for any interim analyses? Is there reason to adjust for multiple testing? Specify who is responsible for the statistical analysis plan.
• 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.
• Time plan: Describe the time plan for the implementation of the study (from start-up to termination) during the grant period, for example in the form of a Gantt chart. 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.
• Specific intermediate 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).
• Risk management: Describe also any crucial risks or obstacles (such as those relating to permits and/or approvals, or recruitment of patients) that may impact on the implementation, and your plan for managing these.
• References: Include references, but limit them to maximum 1/2 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 Opens in new window., which are open to all. If you choose to use other infrastructure instead, please justify this need (also applies for local research infrastructure).

Justification for changing the application

State the changes you have made to the full application based on the feedback you received from the review panel on your outline application. If you have chosen not to make certain suggested changes, please justify this. It is important that you as applicant respond to all feedback from the review panel on your outline application, even if this did not lead to any changes to the application.

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 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 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, 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 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

State which Swedish regions, other researchers and any businesses that 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.

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.

Clinical work

Describe in what way you fulfil the requirement for clinical work 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.

Budget and research resources

Project personnel

State the activity level (per cent of a full-time equivalent) of all personnel active within the project, that is to say yourself, any other researchers and other personnel. Please also state the salary you are applying for, for yourself and/or other personnel active within 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.

Other costs

Describe any other costs of the project (premises costs, running costs and depreciation costs). Please state the 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. 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 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.

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

Participating researchers’ publication lists

Attach all participating researchers’ publication lists joined up into one file. The list for each researcher shall include the 10 publications that are the most relevant to the research 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.

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.

The publications shall be of the types: Peer-reviewed original articles, conference contributions, edited volumes, research review articles, books and book chapters, and 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

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. 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 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?