Research environment grant within clinical therapy 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
• Participants
• CV

Descriptions of the information requested under each tab follow below.

Descriptive information

Abstract

The abstract shall include a brief description of the following:

• what is to be done: purpose and aim
• how the research problem will be studied in an overall project design, including patient selection, variable selection, data collection and analysis methods, and time plan. For intervention studies: please use PICO (population/intervention/control/outcome)
• what the direct patient benefit is from the planned research.

The abstract shall provide a summary guide to 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 (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, and explain 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.

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

The description may cover a maximum of 4 500 characters including blank spaces (approximately one A4 page in Arial, font size 11, single line spacing).

Research 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 human subjects. If no ethical issues are raised, please justify this.

The description may cover a maximum of 4 000 characters including blank spaces (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 research plan (see further instructions under “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.

Research plan

The research plan shall consist of a brief but complete description of the study. The focus shall be forward-looking, and it shall cover a maximum of 10 page-numbered A4 pages in Arial, font size 11, single line spacing, including references and any figures and tables.

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

• Purpose and aims: Describe the research problem and the main purpose together with a short scientific background that justifies the project. Specify the main research question and the primary endpoint, which must be clinically relevant. If you have stated that sex and gender perspectives are applicable, please describe how these perspectives relate to the purpose, goal and questions of the research project.
• Survey of the field: Summarise briefly the current clinical practice and evidence-based clinical knowledge about the research field. List any systematic reviews, national and international guidelines and identify evidence gaps that justify more research being needed (maximum one half of an A4 page). Please exclude any review of pre-clinical and technical data and of the burden of disease. Describe briefly how sex and gender perspectives have been handled previously within the field/area the project relates to.

• 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 treatments should be described in detail regarding for example type(s) of treatment, dose, monitoring periods, evaluation etc. For controlled trials (RCTs), PICO (Population / Intervention / Control / Outcome) can be used. In controlled cross-section studies describe the treatment for the control group. It is not enough to only indicate the standard treatment. Any differences between the routine treatments of the participating clinics should be clearly described. For cohort/observational studies, possible confounders should be identified. Describe how these confounders should be managed. For crossover studies, where the patient is his/her own control, describe the planning of the different treatment periods and how the risk of "carryover" effect etc. should be taking into account. For longitudinal studies, motivate the choice of repeated follow-up sessions. It should be clear which follow-up session that is related to the main outcome of the study. Describe in detail the data collection for register-based studies where patient data is retrieved from the register. All variables shall be stated. For subjectively-based variables, such as PROMs (Patient-Reported Outcome Measures), it is not sufficient to list the names of the questionnaires. It is important to take into account that the registry data of the same variable could have been registered using different types of measuring instruments/assessment forms, which results in non-comparable data.
  
  When applicable, describe how sex and gender perspectives relate to the choice of design, questions, method and materials, population/study participants and also data processing and analysis, for example statistics and presentation of results divided up by sex.
  
  The study design must include the following information under separate headings, listed in the following order:
  
  
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  • Research questions: Structure the purpose in terms of research questions. What is to be studied, and on whom? Please specify the primary variable (primary outcome) of each research question and of any secondary variables as well. The primary variable should be patient-oriented. In treatment effect studies, the effect variable (e.g. difference or percentage change in the primary variable) should also be specified. Justify any use of surrogate variable (surrogate endpoint).
  • Variables and measures: Describe how each variable (primary, secondary, background or explanatory) will be measured/recorded and, in particular, in what form the measure values will be used in statistical description and analysis (for example as binary, ordered categorical, transformed or continuous data). Uni- and multi-dimensional variables, such as pain, ability, severity and quality of life, are commonly assessed using various types of questionnaires and rating scales. In such cases, specify the dimensions/sub-variables of the questionnaires used, as well as the type of scale-categories (e.g. numeric, verbal, VAS), and also any statistical procedures used to modify raw data before recording. The acronym of the questionnaire, or a reference, does not replace the variable descriptions. Please include appropriate references to any questionnaires/rating scales.
  • Material: Patient selection – population, sample. Briefly describe the main important characteristics of the study population, and list the inclusion and exclusion criteria for a representative sampling of patients. Describe also how the participating clinics contribute to the patient selection, and how any differences between clinics that could affect the study will be handled. In registry-based studies, the potential risk of systematic under- or over-registration of patients must be considered when defining inclusion- and exclusion criteria. Describe the randomization approach, and specify who is responsible for the randomization. Also indicate for whom (patient, physician, examiner) the randomization is blinded 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. Calculate the power of the study for the planned sample size taking account of estimated drop-outs, motivated by own experiences, by references to other studies or registers. The distribution of patients on the participating clinics, planned multiple tests, interim-analyses are also issues to consider in the sample size estimation. Also describe how the patient’s compliance to the study will be monitored.
  • Statistical methods: Each research question should be linked to specified statistical methods that are appropriate for description and analyses of the data according to the design. It is not enough to use general concepts such as descriptive statistics, parametric and non-parametric methods. Verify that the data and the research question are conformed to the assumptions of the suggested statistical methods. Examples of other important issues to consider when suitable: How will dependent data be handled, for example within the group and/or between groups? How will longitudinal data, and missing data/drop-outs be handled? Indicate how adjustment from multiple tests will be handled. Which statistical methods are planned for complex data from multi-dimensional questionnaires? Note that the normal distribution could be a possible probability distribution for symmetric quantitative data but never for skewed data or for data from assessments on rating scales. Specify who is responsible for the statistical analysis plan!
  • Time plan: Describe briefly the time plan for the study during the grant period.
  • References: Include references, but limit them to maximum half an A4 page.
  • Project organisation: Describe the project organisation and the participating clinics/hospitals. Clarify your own and the participating researchers’ contributions to the implementation of the project. Describe and justify the competence and roles of the participating researchers in the project, and those of any other researchers or corresponding of importance for the implementation of the project. 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.
  • Specific intermediate objectives: State any specific intermediate objectives to be reported back and evaluated 18 months 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).

Provide the following information also. If a heading is not relevant to your application, please leave it blank.

• 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 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 infrastructures instead, please justify this need (also applies for local research infrastructure).

• Other applications or grants: If you are applying for or intend to apply for other grants from the Swedish Research Council, the relationship between the projects shall be clarified. 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).

Justification of changes in the application

State the changes made to the full application, based on the feedback received from the review panel relating to the outline application. If the change/changes cannot be made, please justify why!

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

Call-specific information

Clinical benefit and health economic considerations

Describe how the project results – in terms of direct patient benefit – are expected to come into practical clinical use within a relatively short period of time (within 2–10 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 (approximately one A4 page in Arial, font size 11, single line spacing).

User involvement

User involvement is necessary to ensure that user viewpoints, and also expressed wishes and needs, are taken into account when selecting the primary outcome variables for the study. Describe the way in which user involvement has been included in the planning of the study and in the choice of primary outcome variables. In addition to patient groups, the concept of user involvement shall include patient organisations, relatives and others who may benefit from the results of the research. If you or anyone else has prioritised among existing evidence gaps within the area with the help of user involvement, please describe this.

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

National collaboration

National collaboration between a higher education institution and a number of county councils/regions (minimum 4 county councils/regions) is a requirement for applications for this grant. State which Swedish county councils/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.

Within certain areas, such as national highly specialised care, or diseases that are relevant to very few county councils/regions, it may be difficult to achieve up to 4 collaborating county councils/regions. If so, please justify this.

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

In a separate text field, please state the number and names of the Swedish county councils/regions that are contributing to patient recruitment. Please make sure the number of county councils/regions corresponds to the number of names selected for participating county councils/regions.

Description of clinical employment

To apply for the research environment grant within clinical therapy research, you must hold a clinical position in Sweden, such as employment as 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. Describe how you fulfil this requirement.

The description may cover a maximum of 750 characters including blank spaces in Arial, font size 11.

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 rounded amounts in SEK.

Other costs

Describe any other costs of the project (premises costs, running costs and depreciation costs). Please state rounded annual amounts. Only additional costs in conjunction with clinical studies are covered by the grant, not other medical care costs.

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 exceeding a certain amount (please contact your administrating organisation for information about the amount that applies to your department)
• the equipment needs for your proposed project 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. You may not include depreciation costs for equipment that is wholly financed via other grants. Please contact your HEI for information about what is included in local research infrastructure, acquisition values or how to calculate depreciation costs.

Total cost

Prisma will automatically add up your budget items listed 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 covered by the project (for which you are not seeking funding under this call).

Please contact your HEI for information on what constitutes indirect and direct costs.

Justification of the budget applied for

Justify briefly each cost applied for in the budget stated. The description may cover a maximum of 4 000 characters including blank spaces (approximately one A4 page in Arial, font size 11, single line spacing).

Other funding

Please state your or any other researcher’s funding over and above what is applied for in this application. Please state rounded amounts in 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.

Please 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 corresponding that are published or accepted for publication at the time of applying. The author 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 maximum 10 publications of greatest importance to your application. For each publication, please state how you contributed to it, 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 the last 8 years: 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 a maximum of 10 publications, in the form of the most relevant publications for the research described, and shall cover a maximum of 1 A4 page. 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 corresponding that are published or accepted for publication at the time of applying. The author 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.

Participants

Under this tab, you shall invite other participating researchers and 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, taking into account the stated limitation in numbers:

• Education: First, second and third cycle higher education and specialist degrees.
• Work: Current employment (including employment form) and longer relevant employment, 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 merits as a researcher.
• Merits and awards: Docentship/associate professorship, supervisees (postdoctoral and doctoral students; state the overall number of each category and list the 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. The applications for grants in clinical therapy research are assessed according to a two-step procedure. First, applicants are required to submit a project outline for evaluation. Applicants, who pass the project outline evaluation will subsequently be asked to submit a full application.

Evaluation process

The full applications for grants in clinical therapy research are assessed by review panels consisted of international researchers. 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 panel External link, 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. Due to the nature of clinical therapy research, the Novelty and originality should be weighted lower than the other criteria.

For the assessment of the 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:

• Is the study design sufficiently described according to the guidelines for the application?
• 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 proposed study design the most adequate design to address the objectives? Would an alternative study design have increased efficiency?
• If any, which are the limitations of the study design?
• Are the variables and measurements/assessments, power calculations, sample size and patient selection convincingly described?
• Has the project a clear statistical analysis design that is linked to the research question?
• Is the project national, i.e. it involves collaboration and patient recruitment from a minimum of four Swedish county councils/regions, or does it involve National Specialised Medical Care? Have similar studies been conducted before?
• 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 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 of the research (1–7)

Guiding questions:

• May the results of the study be directly implementable into clinical practice within a relatively near future (2-10 years after the end of the project)?
• Have the target groups (patient groups, patient organizations, family members and others who may benefit from the research findings) been consulted in the planning of the study and the choice of endpoints?
• 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?
• Does the project have the potential to deliver implementable results beneficial to patients and society?

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?
• 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:

• 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 three years?

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.