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National Cancer Institute
U.S. National Institutes of Health www.cancer.gov
 

Proposal Requirements

What is required?

  • A cover letter signed by the CG/CCOP Chair and the Business Official of the Institution indicating submission of a biomarker, imaging, quality of life, and/or CEA study in response to the BIQSFP announcement. The cover letter should include:
    • – The title(s) of the project(s).
    • – Brief description of the project indicating whether the study(s) is integral or integrated.
    • – Type of study(s) proposed (biomarker, imaging, quality of life, and/or CEA).
    • – Total budget figure requested for each project (biomarker, imaging, QOL, CEA).
    • – Duration of the study.
  • Detailed budget as described in the BIQSFP Budget Preparation & Submission section.
  • The parent clinical trial concept with the biomarker, imaging, QOL, and/or CEA study embedded (for evaluation by SSCs or where appropriate, CTEP or DCP).

Biomarker and Imaging: A separate document is required describing the characteristics and performance of each biomarker assay and imaging test proposed for funding, and its role in the trial. Applicants should refer to the Study Checklist for Large, Randomized Phase 2 or Phase 3 Trials with Biomarker Assay/Imaging Assays for instructions on what information is needed. This section is not to exceed five (5) pages for each assay or test. If both integral and integrated studies are proposed within the same concept being submitted, each study will require a separate BIQSFP Proposal Package as indicated above.

For additional explanations and definitions, investigators are also encouraged to visit Performance Standards Reporting Requirements for Assays in Clinical Trials.

Additional information regarding validation of integral biomarkers can be found at NCI's Cancer Diagnosis Program (CDP) website.

For BIQSFP study proposals containing assays that are not fully developed, applicants can refer to NCI's Clinical Assay Development Program (CADP) website for guidance regarding assay validation.

Quality of Life: A separate document is required describing the characteristics and performance of each measure that validates a QOL assessment and/or an instrument proposed for funding, and its role in the trial. Applicants should refer to the Study Checklist for Randomized Phase 3 Trials with QOL Components for instructions on what information is needed. This section is not to exceed five (5) pages for each assay or test. If both integral and integrated studies are proposed within the same concept being submitted, each will require a separate BIQSFP Proposal Package as indicated above.

Cost-Effectiveness Analysis: A separate document is required describing the rationale and justification of the CEA proposal for funding. The CEA proposal should be a secondary endpoint of the parent study. Applicants should refer to the Study Checklist for Randomized Phase 3 Clinical Trials with a Comparator Arm and Cost-Effectiveness Analysis (CEA) Component(s) for instructions on what information is needed. This section is not to exceed five (5) pages.

A complete Proposal Package, including a cover letter by the Principal Investigator of the Cooperative Group or CCOP Research Base and Cost Estimate Worksheet (s), must be emailed via pdf attachment to the relevant Program office.

CCOP Research Base proposals must be e-mailed to:

Worta McCaskill-Stevens, MD, MS - wm57h@nih.gov

Cooperative Group proposals must be e-mailed to:

E-mail submissions must reference "BIQSFP" in the Subject line.