THRASHER RESEARCH FUND CONCEPT PAPER

Instruction page

Please see our website for current emphasis of what we fund and do not fund. Instructions are written in italics and should be deleted prior to submission. The completed form should be submitted, along with information from the Title Page, through https:/portal.thrasherresearch.org as a Word document.

The Concept paper consists of four pages including:

· Title Page: The purpose of the Title Page is to provide an overview of the applicants, research institutions, and budget necessary to carry out the work. One page limit.

· Scientific Summary: The purpose of the Scientific Summary is to provide the background data, hypothesis, aims, study design, and expected outcomes of the research. If the proposed work is part of a larger study, please only include the hypothesis and aims for the Thrasher supported work. Use the Parent Study Summary to further elaborate on the larger study. One page limit.

· Structured Summary: The purpose of the Structured Summary is to consolidate key elements of the Scientific Summary in an easily referenced list. It is acceptable to copy and paste relevant information directly from the Scientific Summary, although if the description is technical, the language can be simplified in this summary for scientifically educated readers who may not have expertise in the particular topical area. Limit each response to a single sentence unless otherwise noted. One page limit.

· Parent Study Summary (if applicable): The purpose of the Parent Study Summary is to provide sufficient space to detail the hypothesis, aims, study design, and current progress of a parent study. Only fill out this page if your proposal relies on another clinical trial or research proposal for samples or enrollment. Descriptions of the parent study should be limited to this page, so that all other pages of the Concept Paper can focus solely on the portion of the work requiring support from the Thrasher Research Fund. 300 word limit.

Each page should use 11 point Calibri or Arial font and .75 inch margins all around. References are not required or expected. If the applicant feels that a reference is necessary, it should be included within the one page limit, either embedded in the text or inserted at the bottom.


THRASHER RESEARCH FUND CONCEPT PAPER

Title: (limit to 100 characters, including spaces)

Principal Investigator: (include degrees)

Information for Principal Investigator

Academic Position/Title:

Phone:

Email:

Website: (if applicable)

Mailing Address:

Co-Principal Investigators: (include degrees)

Length of Study: (maximum 3 years)

Total Budget: (if a full proposal is invited, the proposal budget should be consistent with the budget amount proposed here - all exceptions must be cleared by the Fund)

Supervising Institution:

Project Site(s):


SCIENTIFIC SUMMARY

Background:

Give a brief general overview of the significance of the problem to children’s health. Estimate the incidence/prevalence of the problem, being specific to the sub-population that might benefit from the research. Include a brief evaluation of previous research, existing knowledge or clinical practice, and include any additional background information indicating the rationale for the proposed research. Specifically identify the research gap(s) the project is intended to address. Include any preliminary data that may support the hypotheses.

Hypothesis(es) and Aims:

State each hypothesis in a single sentence. Briefly describe the related aims.

Design:

Describe how the study will be carried out. Specifically State the design of the study (e.g. randomized controlled trial, case-control, prospective cohort, cross sectional etc).

As applicable, include the following information (can be in paragraph form rather than a numbered list):

1. Study subjects, including major inclusion/exclusion criteria

2. Sample size and resulting power(if there is not a calculated sample size, state this and justify)

3. Other sample material to be used in the study

4. State the primary outcomes and how they will be measured

Potential Impact:

Discuss where the research is leading, in what ways and in how many years the findings might potentially influence the prevention, diagnosis and/or treatment of the particular medical problem in children.


STRUCTURED SUMMARY

Describe the medical problem as it relates to children

·

State the incidence/prevalence of problem in children

·

Background that will lead to the research gap (may use 2 sentences)

·

State the primary research gap this study will address

·

Hypotheses (one sentence per hypothesis)

·

Specific Aims (one sentence per aim, maximum 3)

·

Study design

·

Describe study population or sample material

·

Sample size/power of primary endpoint

·

Assuming the project is successful, state the next step moving down the pathway to clinical applicability

·


Parent Study Summary

Background:

Describe the purpose and include additional background if it differs from the Scientific Summary.

Hypothesis(es) and Aims:

State each hypothesis of the parent project and briefly describe the related aims.

Design:

As applicable, include the following information (can be in paragraph form rather than a numbered list):

1. Design of the study (e.g. randomized controlled trial, case-control, prospective cohort, cross sectional etc).

2. Study subjects, including major inclusion/exclusion criteria

3. Sample size

4. State the primary outcomes and how they will be measured

Progress of Parent study:

Describe the progress of the study to date, including anticipated starting and ending dates, and enrollment status.

Parent Study Funding: Describe parent study funding source(s) for the proposed project. Including grant title(s) and dollar amount(s).