Title: Proposal Preparation Instruction Clinical Trials Programme - Draft Proposals
Subject: Klinische Studien
Last saved by: Fleige, Beatrix
Category: Vordrucke
Document comments: Dokumentvorlage erstellt von Dipl.-Ing.(FH) Markus Hahner, www.hahner.de

DFG form 17.03 – 09/26	page  of

Proposal Preparation Instructions
Clinical Trials Programme – Draft Proposals

Please write your proposal in English and use the Draft Proposal Template (DFG form 53.13). 
www.dfg.de/formulare/53_13_elan

The proposal must not exceed 8 pages (DIN A4, 10 point Arial for the regular text and 9 point Arial for the synopsis, single line spacing). Make an entry under each heading/subheading. Original signatures of the principal/coordinating investigator and the responsible statistician on the compliance form are mandatory. 

As a separate document submit an academic CV with a list of the most important scientific results for each applicant, co-investigator and statistician The template provided (DFG form 53.200) must be used for this purpose.
www.dfg.de/formulare/53_200_elan
For further information on the publication list, see:
www.dfg.de/formulare/1_91
Applications that fail to comply with these requirements will not be considered for review. 
The project information must contain a summary of the proposal in German and in English. 
Submit the draft proposal and CVs electronically via elan.
elan.dfg.de
1	Trial Synopsis

Applicant(s) /
coordinating 
investigator(s)

List the name of the person who will apply for funding and assume responsibility for conducting the clinical trial. Two applicants may only be listed in exceptional cases, for example, if the duty to cooperate (DFG form 55.01) applies.  

•	First name, last name, academic title
•	Employment status
•	Institution and department (complete name)
•	Postal address
•	Telephone/e-mail address

Each applicant should submit an academic CV.

Statistician

List the responsible statistician.

•	First name, last name, academic title
•	Employment status
•	Institution and department (complete name)
•	Postal address
•	Telephone/e-mail address

The statistician should submit an academic CV.

Co-investigator(s)

List co-investigator(s), if applicable. Limit the number of co-investigator(s) by naming only those who will substantially contribute to the design, management and analysis of the trial but will not apply for funding. This usually does not include the main investigators of participating recruiting centres. 

•	First name, last name, academic title
•	Institution and department (complete name)
•	Postal address
•	Telephone / e-mail address

Each co-investigator should submit an academic CV.

Title of trial (English)

The title of the trial should be as precise as possible. Indicate the study’s design with commonly used terms in the title. An acronym is optional.
If funding is granted, this title will be used in the DFG’s publicly accessible database of funded projects.

Title of trial
(German)

See above.

Medical condition | The medical condition being studied (e.g. asthma, myocardial infarction, depression)
Hypothesis | Clearly specify the hypothesis of the trial that determines sample size calculation.

Participants / study population

Specify the population to be studied. 

Key inclusion criteria:
Key exclusion criteria:

Trial type

Please mark which trial type you are applying for under this programme.

Confirmatory trial:	☐

Observational trial:	☐

If you have chosen an observational trial, please justify your decision briefly: 

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Present key elements of your trial design here, e.g. randomized/non-randomized, type of masking (single, double, observer blind), type of controls (active/placebo), parallel group/cross-over, prognostic, diagnostic.

Key elements:

Is the approval of a competent federal authority necessary

No   ☐ 

Yes ☐ 

Give reasons for your answer and briefly explain which federal authority’s approval is to be obtained.

Treatments / procedures

Detail your trial design by describing the treatments/procedures (intervention, dose and mode of application) that will be compared.  

Experimental intervention:
Control intervention:
Follow-up per patient:
Duration of intervention per patient:

Endpoint(s)

Primary endpoint:
Secondary endpoint(s):
Assessment of safety:

Trial duration

First patient in to last patient out (months): 
Duration of the entire trial (months):
Recruitment period (months):

Statistical analysis

Statistical methods used to compare groups for primary and secondary outcomes:
Methods for additional analyses, such as subgroup analyses and adjusted analyses:

Sample size

To be assessed for eligibility:                        (n =   )
To be assigned to the trial, i.e. recruited:     (n =   )
To be analysed:                                               (n =   )

Participating sites

How many centres/sites will be involved and where are they located?

No. of cities to be involved:  
No. of centres to be involved: 
Names of cities and centres:

Previous DFG project number | If applicable, provide the DFG project number of any previous proposal(s) for project funding concerning this trial.
Submission of proposal elsewhere | Please indicate whether the same or a similar version of the proposal is currently being submitted to another funding organisation.
2	Proposal History / Project History
•	Briefly describe whether previous proposals (draft or full proposals) relating to this trial have been submitted to this programme and what important changes have been made with regard to previous versions or in response to reviewers’ comments.
•	For revised proposals, a separate two-page response letter (10 point Arial) can be submitted to comment on reviewers’ suggestions and critiques. 

3	Trial Design
•	Provide a schematic diagram that describes the trial design, intervention(s)/observations and procedures. The diagram below represents an example of an interventional trial as recommended by CONSORT.
4	Medical Problem and Relevance
•	Describe the medical problem in terms of prevalence, incidence, mortality and burden of the disease. 
•	What therapy options are available for treatment of the disease? 
•	What research question arises from the medical problem that will be addressed in the trial? 
•	What is the novel aspect of the proposed trial? 
•	What impact will the results have in terms of relieving the burden of disease and/or improving human health? That is, how will the individual patient and the patient population benefit from the trial? 
•	What impact will the results have on clinical practice?
•	Do sex, gender and/or diversity aspects play a role in the medical problem, the treatment options of the disease or in the proposed trial? If applicable, please consider this when answering the previous questions and throughout the proposal and trial (i.e. design aspects, analysis, results).
5	Patient Involvement
•	How have patients or their respective organisations been involved in planning the trial? 
•	What effect did patient involvement have on planning and designing the trial?
6	Evidence
6.1	Search Strategy
•	Describe how you searched for the evidence. Indicate which databases were searched (such as DRKS, Clinicaltrials.gov, Cochrane, Medline). Include search terms, limits, date of search and time period covered. 
•	State the results of your database search by listing the number and type of hits per search term(s).
6.2	Discussion of Evidence 
•	Cite and discuss the related literature and findings from e.g. relevant systematic review(s), (your own) pilot studies, feasibility studies, relevant previous/ongoing trials and case reports/series. 
•	Unpublished data should also be briefly summarised here.  
•	Use the existing evidence to put your trial into perspective and to substantiate your hypothesis.
•	Justify why the pilot data is sufficient to plan a larger-scale confirmatory trial. 
7	Justification of Design Aspects
7.1	Observational Trial, if Applicable
•	If you are applying for an observational trial under this programme, justify your choice of an observational design and explain why an interventional design cannot be used to address your research question.
7.2	Control(s) / Comparator(s)
•	Justify the choice of control(s)/comparator(s).
7.3	Participants / Study Population
•	Justify the population to be studied, i.e. the selected inclusion and exclusion criteria, and include reflections on generalisability and representativeness, and aspects relating to sex, gender and/or diversity.
7.4	Treatments / Procedures
•	Justify and describe the chosen treatments/procedures (intervention, dose and mode of application) that will be compared in your trial.
•	Justify the duration of treatments/procedures and follow-up per patient.
7.5	Outcome Measures
•	Justify the endpoints chosen.
•	Have the endpoints been validated in other clinical trials? 
•	Are standardized / core outcome sets included in the endpoints chosen? If not, please justify.
•	Are there any guidelines proposing this endpoint/these endpoints?
•	Discuss the clinical relevance of the outcome measures for the target population or the individual patient.
•	Justify the mode of and rationale for data collection.
7.6	Methods Against Bias
•	Name and discuss potential sources of bias. 
•	Justify your strategy to prevent bias by addressing randomization and blinding as well as potential trial-site effects and differences in expertise of persons executing treatments.
•	If randomization and/or blinding is not feasible, explain why.
•	For observational trials, describe how you aim to prevent bias in the selection and matching of patients. Consider confounders and their influence. List further sources of bias that apply to your trial (e.g. trial-site effects) and describe your strategy to address them.
7.7	Proposed Sample Size / Power Calculations
•	What is the proposed sample size and what is the justification for the assumptions underlying the power calculations? 
•	Include a comprehensible, checkable description of how sample size was calculated.
•	Detail outcome measures, event rates, means and medians, the software used for sample size calculation, etc., as appropriate. 
•	Take anticipated rates of non-compliance and losses to follow-up into account.
7.8	Feasibility of Recruitment / Access to Study Population
•	What is the evidence that the intended recruitment rate or access to study population is achievable (e.g. pilot data)? 
•	Describe the data from which you have assessed the potential for recruiting/accessing the required number of suitable subjects. 
•	Comment on the occurrence of the disease, the access to patients and their willingness to take part in a trial, especially when randomized.
8	Statistical Analysis
•	What is the proposed strategy of statistical analysis? 
•	What is the strategy for analysing the primary outcome? If applicable, how will multiple primary endpoints be analysed statistically?
•	If interim analyses are planned, please specify. 
•	Will there be any subgroup analyses? 
•	How will missing data and/or subjects who have withdrawn from the trial be handled statistically?
•	For observational trials, describe how the influence of confounding variables will be addressed in the statistical analysis.
9	Ethical Considerations
•	Discuss briefly the acceptability of the risk incurred by the individual participant versus the potential benefit for the participant/population concerned.
10	Budget Summary
•	Please give a rough estimate of the costs expected for the entire duration of the trial and the funding period currently applied for.
Item | Amount for entire trial (€) | Amount for current funding period (€)
Clinical project management | |
Project management | |
Case payments | |
Data management | |
Biostatistics | |
Quality assurance | |
Travel | |
Materials | |
Trial drugs | |
Fees and insurance | |
Other | |
Total (€) | |

11	Commercial Interest
•	Describe any potential commercial interest of a company in the results of the trial or explain why no such interest exists. Please note that proposals for trials whose outcomes are of direct commercial interest to a company are not eligible for funding.
•	Is the trial drug or the therapeutic, diagnostic or prognostic procedure that is the object of this trial under patent protection?

☐ Yes, until (date):	☐ No
If yes, please specify.

•	Please indicate if you are the owner of a commercial enterprise or a stakeholder in one (e.g. a director). If so, please state how your research project is linked to the company’s production branch or activities. Please refer to DFG form 4.03, “Information on Work Results and Usage Rights in the Event of an Association with a Company“.
www.dfg.de/formulare/4_03
12	Co-Financing of the Trial by a Company or Other Third Party
☐ Yes, until (date):	☐ No
If yes, please specify.

If you will be conducting your project in cooperation with a commercial enterprise, please note the EU guidelines on state aid. Depending on the circumstances, it may be necessary to conclude a contract with the company or submit a declaration to the DFG. Please refer to DFG form 4.02 “Guidelines on the Participation of Commercial Enterprises in Research Projects”. If applicable, please contact your research institution in this regard.

Framework for State Aid for Research and Development and Innovation (2022/C 414/01).

www.dfg.de/formulare/4_02
13	Researchers in Germany and abroad with whom you have agreed to cooperate on this project
•	List any researchers in Germany or abroad with whom you have agreed to cooperate on this project. Any such agreements must be attached to the proposal.
14	Researchers with whom you have collaborated scientifically within the past three years
This information will assist the DFG’s Head Office in avoiding potential conflicts of interest during the review process.
15	Project- und subject-related list of publications
This list of publications is used for general reference. This list should only contain the works you cited.

The font used for the publication list should not be less than Arial 9 point. For both new proposals and renewal proposals, you can refer to your own works and those of others; there is no limit to the total number of publications listed. Works which are not in the public domain are not considered publications and cannot be cited. An exception is made for papers that have already been accepted for publication, in which case the manuscript and the editor’s confirmation of acceptance must be enclosed.

A maximum of ten of your own publications that are most relevant to the project can be highlighted in bold or some other way. Even if there are several applicants, the maximum of ten highlighted works may not be exceeded.

For further information, see the Guidelines for Publication Lists.
www.dfg.de/formulare/1_91

Do not exceed a maximum of 8 pages including headings 1 to 15.

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