Grant for planning of clinical studies in therapy research

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

Research of relevance for this call relates to 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 2–10 years after completion of the project). The research shall be clinically based and therefore assumes access to healthcare structures and resources, and shall relate to studies using human subjects and not animals. The main part of the work for the project shall be conducted in Sweden, but it is possible to collaborate with foreign higher education institutions.

Purpose of the grant

You can apply for the planning grant to complete a pilot study or preliminary work ahead of an application for a grant for clinical studies in therapy research Opens in new window.. The preliminary work should map whether a future well-defined research project is feasible. The mapping may, for example, include a plan for national recruitment of patients, or (if the patient base is limited), formulate how an expansion of the number of patients and participating clinics/centres can be implemented. The feasibility may also be affected by problems with or delays in the procurement and manufacture of trial medicines or permit applications, and how these can be avoided. Conducting a systematic review in order to get a better picture of the state of knowledge may also form part of the planning.

The planning grant may also include collaboration with the users involved, and enabling active user participation on future projects.

You may also includes costs of creating a national network with different researchers and actors to coordinate a research question of high scientific quality that is relevant to clinical therapy research.

The aim of the grant should be to enable submission of an application to the Swedish Research Council within 1–2 years in conjunction with calls for grants for clinical studies in therapy research.

National collaboration

National collaboration will be a requirement for a future application for a grant for clinical studies in therapy research. Even though national collaboration is not a formal requirement for this grant, it is important that your applications includes a clear ambition and plan for how the project can achieve national participation in the long run.

National collaboration entails collaboration between a number of regions (minimum four), and may include universities. This collaboration is important to ensure the study and its results have greater impact. 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 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 should also be taken into account.

Applicant

The applicant must 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. The degree award date we use is the date you fulfilled all the requirements for a doctoral degree, such as mandatory courses, oral defence and an approved doctoral thesis. 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 work in Sweden, that is to say be employed and carry out clinical work as a physician, nurse, dentist or physiotherapist, or similar. 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 work” below).

Grants from the Swedish Research Council shall be administered by a Swedish higher education institution (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. The administrating organisation must sign your application in Prisma no later than 7 calendar days after the deadline for this call.

If you are awarded a grant, you must be employed by the administrating organisation at the start of and throughout the grant period and any additional availability period, unless the Swedish Research Council approves an exception from this requirement. The employment must equal at least 20 per cent of a full-time equivalent. You do not have to be employed by the administrating organisation at the time of applying.

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 refuse your application.

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

You may only submit one application for this grant under this call. On the other hand, you may be included as a participating researcher in several applications under the call. The table below shows information and restrictions for the grants you may apply for during the same year.

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. 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.

The table below shows information and restrictions for the grants you may apply for if you already have an ongoing grant. Please note that you may not apply for this grant if you are the project leader for an ongoing research environment grant or an ongoing grant for planning of clinical therapy research.

Please note also that you cannot later apply for a grant for clinical studies in therapy research if you have an ongoing distinguished professor grant or are a researcher recruited through the Swedish Research Council’s international recruitment call with a grant period that overlaps the grant period for the planned grant for clinical studies in therapy research. On the other hand, you may participate in such an application.

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 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, 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 may apply for grant funds to pay for project and collaboration-related running and salary costs (for your own salary or for other persons included in the project), however no more than corresponding to the person’s activity level in the project. For further information, please see instructions under “Other costs” below.

You cannot apply for a grant to buy equipment or for depreciation. Grants may not be used for scholarships either. If a doctoral student participates, project funds may not be paid out as salary during teaching or other departmental duties.

The minimum amount you may apply for is 400 000 SEK per year, including indirect costs. The maximum amount you may apply for is 1 200 000 SEK in total.

Grant period

You may apply for a grant for a minimum of 1 year and a maximum of 2 years, starting in January 2022. The first payment will be made in January 2022 at the earliest.

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
• Project description
• 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 aims
• A brief description of the state of knowledge and the position of the research field, preferably with reference to previous systematic reviews
• How the research will be carried out: project organisation, time plan and scientific methods
• What is important about 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 project in such a way that a person who is not familiar with the subject can understand it. Describe what is to be done, and why. Explain also in what way the new knowledge may be important.

The popular science description is an important tool when we inform about the research funded by the Swedish Research Council. If we grant your application, we reserve the right to use the description for information purposes.

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.

Note: The popular science description must be written in Swedish, unlike the rest of the application.

Project description

Ethical considerations

Describe the ethical issues raised by your project or corresponding. 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. How do your research questions and expected results measure up in relation to the ethical issues? Please also state whether the research involves any handling of personal data or experiments using human subjects. If no ethical issues are raised, please justify this.

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.

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”: Justify your answer, and describe also how you take account of sex and gender perspectives in the project plan (see further instructions under “Project plan”). If you have stated that sex and gender perspectives are applicable, but still choose not to include them in your project 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.

Project plan

The project plan shall be forward-looking and consist of a brief but complete description of the project. 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 project 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.
• Survey of the field: Describe briefly (maximum 1/2 A4 page) the evidence-based knowledge background and the current clinical practice of the research field. List any systematic reviews, national and international guidelines and identify gaps in knowledge that justify more research being needed. Summaries of pre-clinical and technical data and of the disease burden may be excluded. If a reliable systematic review is lacking for the question, then one should be carried out to ensure that research into the question is justified. A systematic review should be conducted according to the PRISMA statement External link, opens in new window.. Please also consult SBU’s method book External link, opens in new window.or alternatively Cochrane handbook External link, opens in new window. for implementation and methodological aspects.
• Research idea: Describe the research question. 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, please explain why.
  Please justify how the selected study design is adequate for the research question.
• Network description and mode of collaboration: Please describe the following:
  • how the collaborating partners within the network complement each other
  • the collaboration structure, that is leadership and role division among the participating parties
  • how national collaboration will be achieved
  • joint seminars, meetings or workshops, aimed at further developing the research question
  • how senior and junior clinical researchers will be involved, and how an even gender distribution of participating researchers will be considered
  • preparation/planning of joint application for a grant for clinical studies in therapy research.
• Survey of the feasibility of the planned study:
  • Design of the work with regulatory issues. Describe the work on regulatory issues that are topical for your project, such as approval from the Swedish Ethical Review Authority and permits from the Swedish Medical Products Agency.
  • Design and method of the preparatory work. Describe how the planned design and method of the preparatory work will answer the question about feasibility planned for the application for a research environment grant within clinical therapy research, in relation to the items listed below.
    • Making an inventory of the patient material – number of patients possible to include in the study.
    • Obtaining ethical approval for the research project with the aim of applying for a research environment grant within clinical therapy research.
    • If relevant, obtaining medicine approval for the research project.
    • If relevant, starting the procurement of trial medicines to be used in the research project.
    • If relevant, obtaining a quote for a placebo.
    • Other preparatory work relevant to the research project planned for a follow-up application.
• Outcome: The description shall specify how the planning grant can lead to the development of a clinical therapy study, in relation to the following:
  • variables and measures
  • study design
  • estimated sample size and power
  • material: patient selection – population, sample
  • statistical analysis plan
  • clinical benefit
  • health economics considerations
  • user participation
  • implementation
  • national collaboration.
    Further information on the items above is described in the call text for grant for clinical studies in therapy research. Opens in new window.
• User participation Describe how this grant can be used to establish good user participation, and please include the following in the discussion:
  • Why the question is regarded as important to patients, relatives and professions
  • How outcomes are produced through active user participation
  • How users can be involved in the planning and implementation of the study, information material, and the dissemination of study results
• Plan ahead of outline application: Describe your plan for how the pilot study or preliminary work will lead to an application for a grant for clinical studies in therapy research.

Please also provide the following information, if relevant to your application.

• Other applications or grants: If you are applying for or intend to apply for other grants from the Swedish Research Council, please clarify the relationship between the projects. This applies also if you are receiving ongoing grants from the Swedish Research Council with grant periods that wholly or partly overlap with the grant you are now applying for. You should also justify why you are submitting one or several further applications. Describe also the relationship with other applications to or grants from other funding bodies for the same project concept (from you or another researcher).

Participating researchers

State the names and affiliations of any participating partners (for example from health and medical care, business or user representatives).

The text 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 work

Please confirm that the scope of the clinical work you are carrying out correspond to at least 20 percent of a full-time employment at the time of application and throughout the project period.

Describe also 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

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 the running costs for all planned activities within the project by specifying the items below. Please state the amounts in Swedish krona, rounded to the nearest 1 000 SEK.

• Costs of obtaining ethical approval, medicine permits, procurement, etc.
• Costs of preparation/planning research grant application
• Costs of travel, collaboration activities, joint conferences, workshops, seminars, etc.
• Costs of joint publications and other joint information dissemination

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).

Please contact your administrating organisation if you have any questions abut what constitutes indirect and direct costs.

Justification of the budget applied for

Justify briefly each cost applied for in your budget. 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.

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 2 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 2013–2021: 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 administrators to your application.

CV

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

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. The committee for Clinical Therapy Research lends support to clinical studies which are justified by the needs of the healthcare sector, and thereby offer important benefits to patients and society within a relatively short time frame.

Evaluation process

The applications for planning grants in clinical therapy research are assessed by review panels consisted of 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 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.

Evaluation criteria and guiding questions

The evaluation of the scientific quality of your application is made based on five criteria (Scientific quality of the proposed research, Patient value – benefit of the research, Novelty and originality, Merits of the applicant, Feasibility). The purpose of using several components is to achieve a multi-faceted evaluation. Only applications that have been assessed to have high scientific quality and patient value will be consider for funding. Due to the nature of clinical therapy research, the Novelty and originality should be weighted lower than the other criteria.

The criteria are assessed on a seven-grade scale, except for feasibility, which is assessed on a three-grade 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.

Scientific quality of the proposed research (1–7)

• Is the main research question motivated and specified?
• Are the purpose and the plan for how the proposal will lead to an application for a research environment grant within clinical therapy research clarified and well justified?
  • Are the planned activities clearly specified and fit for purpose, for example how to work on regulatory issues topical for the project, such as approval from the Swedish Ethical Review Authority, permits from the Swedish Medical Products Agency, etc.
  • make an inventory of the patient material – number of patients possible to include in the study
  • obtain medicine approval for the research project
  • start the procurement of trial medicines to be used in the research project
  • obtain a quote for a placebo
  • optimize the study design and include a statistical analysis plan
  • meet the requirement on national collaboration
  • gather necessary expertise and actors to create a network that can lead to a future application for research environment grant within clinical therapy research
  • perform a systematic review of the research field if systematic reviews are lacking for the research area
• If an intervention study is proposed: Will the inclusion process be sufficient to reach the included number of patients in the described period of time? For other study designs: Is the target study population defined and sufficiently large?
• Is there a well worked-out plan for how both junior and senior researchers will participate in the network?

Patient value – benefit of the research (1–7)

• Is there a well worked-out plan for how to include users (that is to say patients, patient organisations and relatives) in the planning of the study and the choice of endpoints?
• May the results of the planned clinical therapy study contribute to a better use of the resources in the healthcare sector? Factors such as prevalence, the severity of the disease, the current burden on the health care system, and social costs should be weighed in the assessment of clinical relevance.

Novelty and originality (1–7)

• Have similar studies been conducted before? If so, why is the proposed one needed?
• Does the planned study have the potential to deliver implementable results beneficial to patients and society?

Merits of the applicant (1–7)

• Does the team have a track record in carrying out research within the subject area?
• Has any team member been involved in critical assessments or guideline establishment?
• If an intervention study is planned: Is there any involvement of a clinical trials unit or any trial staff (if applicable)?
• Does the application contain a plan for statistical competence and feasibility?
• Does the main applicant have documented experience of leading major collaboration projects? If not, is there a clear description for how senior members in the project group will provide this competence to the governance of the project?

Feasibility (1–3)

• Has the proposed project potential to result in an application for a research environment grant within clinical therapy research within 1-2 years?
• Is the planned preliminary work, including the time-frame, realistic for the proposed project?
• Are the study design, statistical methods and patient cohorts adequate and well adapted to the research question?
• Are the costs reasonable and well justified?

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.