Allowable Studies and Costs
- Are QOL/PRO studies eligible for BIQSFP funding?
- Are study applications associated with phase 2 trials eligible for BIQSFP funding?
- Can salary support be requested?
- Does BIQSFP funding support biospecimen and tissue procurement and analyses?
- Should applicants indicate steps taken for reducing the cost of assays/tests/assessments/tools?
- What is the value of Cost-Effectiveness Analysis?
Preparing the BIQSFP Submission
- May a study application with several biomarker, imaging, QOL/PRO, Symptom Science, & CEA components be submitted on one checklist?
- Is there a page limit for the BIQSFP Proposal Package?
- Why are SOPs for assays/tests/tools/assessments suggested as part of the Proposal Package?
- Should a description of the BIQSFP project(s) be included within the Parent Concept application?
- What do I submit to request consideration for BIQSFP funding?
- Is the signature of the Institutional business official needed at time of BIQSFP Proposal Package submission?
- When is an INTEGRAL study application to be submitted?
- When is an INTEGRATED study application to be submitted?
Review and Funding of BIQSFP Proposals
- Who evaluates and approves the BIQSFP proposals?
- Once CTROC has recommended the BIQSFP study for funding, does the BIQSFP approval process proceed simultaneously alongside the final parent protocol review approval process?
- How does the process for the BIQSFP funding correlate with the OEWG Protocol approval guidelines/timelines implemented in early 2011?
- How many proposals do you expect to fund? Is there a funding limit?
- We’re completing our BIQSFP-funded protocol and preparing for publication of the findings.
- Is there a website I can go to for additional BIQSFP information, forms, templates, approved studies, guidance, details, etc.?
- Who do I contact if I have specific BIQSFP program questions?
Are QOL/PRO studies eligible for BIQSFP funding?
QOL/PRO studies should be submitted for DCP credits. QOL/PRO proposals must include a letter from the Division of Cancer Prevention (DCP) indicating that the proposed costs exceed allowable DCP credits/resources and that DCP has agreed that the study should be considered for BIQSFP funding.
Are study applications associated with phase 2 trials eligible for BIQSFP funding?
YES… biomarker, imaging, and symptom science studies are eligible.
Can salary support be requested?
YES… Funding for technical support and consultants can be requested as long as the costs are justified for the BIQSFP component of the trial and are not part of the costs inherent in the parent trial. For example, costs for biostatistical effort are inherent to the parent trial and would generally not be eligible, whereas a technician's or psychologist’s time to conduct a laboratory assay or administer a neurocognitive exam that is proposed in the BIQSFP study would be eligible. BIQSFP funds can support the effort of a statisticain when the statistical analysis is adequately justified as a need beyond the normal analysis needed for design of the clinical trial, specifically for the BIQSFP-supported assay/test, and usually for INTEGRATED studies. BIQSFP funding does not support the effort of NCTN group/NCORP chairpersons or statisticians, or in general, the effort of the study Principal Investigator of the parent clinical trial concept as this would be expected to be included in the NCTN/NCORP grants.
Covered BIQSFP costs may also include but not be limited to procurement of and completion of research assays on blood or tissue, central pathology or image reading, and shipping. Costs associated with QOL/PRO assessments that are conducted as part of CEA may be included.
Travel costs and publication costs are not supported by BIQSFP funding.
Does BIQSFP funding support biospecimen and tissue procurement and analyses?
BIQSFP does not normally support biospecimen and tissue procurement and analysis which focuses on assay development or that could be conducted in the future on stored specimens. BIQSFP supports biospecimen and tissue shipping costs along with analysis if the results are critical to the stated primary or secondary objectives of the approved trial. It is recommended that these questions be discussed with CTEP or DCP Program Staff prior to BIQSFP submission to determine eligibility.
Should applicants indicate steps taken for reducing the cost of assays/tests/assessments/tools?
YES…NCTN group/ NCORP investigators are encouraged to explore options for reducing the cost of assays/tests/assessments/tools to be supported by BIQSFP funding. These cost sharing options might include billing third party payers or partial funding from commercial partners, or choosing between academic vs. commercial labs. Cost comparisons are appropriate to justify the site chosen to complete the assay/test/assessment/tool, where applicable. Investigators’ use of commercially available laboratory tests may aid in reducing budgetary requirements. Demonstration of cost sharing with other funders will have a positive impact on the evaluation.
What is the value of Cost-Effectiveness Analysis?
Cost-Effectiveness Analysis (CEA) provides useful information to help health care payers manage the use of costly medical technologies in order to maximize the health of their patient populations when facing constrained budgets, and to clinicians and patients to help guide treatment decisions based on CEA’s unique endpoints, perspectives (e.g., societal, clinical, or third-party), and time horizon (e.g., within trial or long-term survivorship). To be most useful to decision-makers, CEA of new cancer therapies must have maximal feasibility, be timely, and have high internal validity.
Conducting a CEA alongside a clinical trial can achieve these goals and also offers the benefit of efficiency by utilizing the existing structure of clinical trials to collect additional data for the economic analysis. It is not required that a CEA proposal be included with each clinical trial concept submitted. However, in some instances the addition of CEA may be recommended during evaluation of the clinical trial concept. CEA funding may also apply to Symptom Science/Supportive Care clinical trials. The evaluation of CEA paired with phase 3 clinical trials is the responsibility of the SCs. NCI's Clinical and Translational Research Operating Committee (CTROC) makes the final funding recommendations.
May a study application with several biomarker, imaging, QOL/PRO, Symptom Science, & CEA components be submitted on one checklist?
NO...a separate Study Checklist and a separate Form PHS 398/Budget Justification need to be submitted for each integral and integrated biomarker, imaging, QOL/PRO, or CEA component for which BIQSFP funding is requested.
Is there a page limit for the BIQSFP Proposal Package?
NO... but there is a five-page limit for each Biomarker, Imaging, and QOL/PRO/Symptom Science Concept Checklist. In addition, there is an eight-page limit for the CEA Checklist. There is no overall page limit for the Proposal Package. Applicants are encouraged to submit a Standard Operating Procedure (SOP) as an appendix to the BIQSFP Checklist when the SOP supports validation of the assay/test/tool/instrument(s) being proposed.
Why are SOPs for assays/tests/tools/assessments suggested as part of the Proposal Package?
Applications may not include sufficient details for assessing the precision, sensitivity, and reproducibility of the assay/test/tool/instrument(s) being supported. SOPs can help in demonstrating validation of these characteristics.
Should a description of the BIQSFP project(s) be included within the Parent Concept application?
YES…a description of the INTEGRAL proposal(s) requesting BIQSFP support must be embedded into the parent concept document (see CTEP Phase 2, 2/3, and 3 Trial Concept Submission (v4.1) form, Section 3.3). This will become part of the protocol as well.
Although detailed descriptions of anticipated or planned INTEGRATED proposals are not required at the time of parent concept submission, these studies should be noted on the respective CTEP/NCORP Trial Concept Submission Form and must be included in the secondary objectives for the trial.
What do I submit to request consideration for BIQSFP funding?
All resources needed for the BIQSFP Proposal Package can be found on the BIQSFP website at: https://www.cancer.gov/about-nci/organization/ccct/funding/biqsfp including the BIQSFP Guidelines, Frequently Asked Questions (FAQs), Concept Checklists, Budget/Budget Justification, and Program Contacts. BIQSFP Funded Studies are also available on the website.
BIQSFP Proposal Package - What is required?
- A cover letter signed by the NCTN Group/NCORP Research Base Chair indicating submission of a biomarker, imaging, QOL/PRO, or CEA study proposal in response to the 2018 BIQSFP Guidelines. The cover letter should include:
- The title(s) of the BIQSFP project(s)
- Title and protocol number of the parent clinicl trial concept associated with the biomarker, imaging, QOL/PRO, and/or CEA proposal
- Brief description of the project(s) indicating whether the study(s) is integral or integrated
- Type of study(s) proposed (biomarker, imaging, QOL/PRO, and/or CEA)
- Total budget figure requested for each project
- Duration of the study
- Detailed budget
- Total composite budget that details the cost (direct and indirect) for each biomarker, imaging, QOL/PRO and/or CEA study proposal submitted
- Use the Form PHS 398
- Include a narrative justifying each requested cost
- Covered BIQSFP costs may include, but are not limited to, procurement of adn completion of research assays on blood or tissue, centeral pathology or image reading or shipping
- Costs associated with QOL/PRO assessments that are conducted as part of CEA may be included
- Salary and meeting travel costs for the PI of the clinical trial/study and/or NCTN Group/NCORP Research Base leadership are not covered under the BIQSFP program
- Investigators are encouraged to explore options for reducing the cost of assays and tests to be supported by BIQSFP funding, perhaps by billing third party payers, obtaining partial funding from commercial partners, or choosing the lowest priced laboratory
- The signature of the institutional business official is not required at the time of initial submission of the total composite budget. Institutional approval and sign-off is required once the final funding has been approved by the NCI
The Budget packet must include a completed NIH biosketch form for each study PI. Form SF424 can be found at: http://grants.nih.gov/grants/funding/424/index.htm#format. Additional information on the new biosketch requirements can be found at: http://grants.nih.gov/grants/forms/biosketch.htm.
Lastly, the Proposal Package includes the parent clinical trial concept with the biomarker, imaging, QOL/PRO, and/or CEA study embedded (for evaluation by SSCs or where appropriate, CTEP or DCP).
Is the signature of the Institutional business official needed at time of BIQSFP Proposal Package submission?
NO... institutional approval and sign-off will be required once the final funding has been approved by NCI.
When is an INTEGRAL study application to be submitted?
INTEGRAL Proposal Packages must be submitted at the time of parent concept submission and will be evaluated by the steering committee at the time of parent concept review. Proposal Packages must be submitted to the respective PIO (CTEP or DCP Protocol Information Office PIO).
When is an INTEGRATED study application to be submitted?
INTEGRATED Proposals should be noted on the respective CTEP/NCORP Trial Concept Submission Form and included as a secondary objective of the trial. REAL TIME integrated studies should be submitted following principal investigator (PI) notification of parent study approval by the respective CTEP/DCP Protocol Information Office (PIO). NON-REAL TIME integrated studies will be accepted only after the trial has reached at least 75 percent of the protocol-specified accrual goal and no later than six months following the publication date of the trial’s primary outcome.
Who evaluates and approves the BIQSFP proposals?
BIQSFP proposals are evaluated by the appropriate NCI Steering Committee (SC). If no SC exists, CTEP or DCP (as applicable) evaluates the proposals using existing procedures including outside expert ad hoc evaluators. Final prioritization and funding decisions on meritorious proposals are made by the Clinical and Translational Research Operations Committee (CTROC).
Once CTROC has recommended the BIQSFP study for funding, does the BIQSFP approval process proceed simultaneously alongside the final parent protocol review & approval process?
NO…the BIQSFP evaluation and approval is completed once CTROC recommends the study for funding. Funding will be via an Administrative Supplement to the respective parent U10/UG1 grant. BIQSFP funds will be available when the protocol receives final approval and opens to accrual. BIQSFP funding is contingent on final approval of the parent protocol.
How does the process for the BIQSFP funding correlate with the OEWG Protocol approval guidelines/timelines implemented in early 2011?
The NCI Steering Committees (SCs) evaluate and prioritize concepts (including those that have an associated BIQSFP) in accordance with OEWG timelines. While a BIQSFP funding decision can occur early in the process, timelines for development and activation of the parent protocols will be in accordance with the OEWG recommendations.
How many proposals do you expect to fund? Is there a funding limit?
The number of proposals that will be funded is contingent upon the availability of funds and the number of meritorious applications submitted. NCI committed approximately $10 million in total costs in fiscal year 2018 to this program.
We are completing our BIQSFP-funded protocol and preparing for publication of the findings. How do we cite the BIQSFP funding we received?
Upon completion of BIQSFP-funded studies, publications should acknowledge the funding source as follows: “This clinical study was supported in whole or in part by funding from the Biomarker, Imaging, QOL Studies Funding Program (BIQSFP) awarded by the National Cancer Institute.”
Is there a website I can go to for additional BIQSFP information, forms, templates, approved studies, guidance, details, etc.?
YES…the BIQSFP website is: http://www.cancer.gov/about-nci/organization/ccct/other-programs/biqsfp
Whom do I contact if I have specific BIQSFP program questions?
Please see the BIQSFP Contacts Page