Allowable Studies and Costs
- Are Cost Effective Analysis (CEA) studies eligible for BIQSFP funding?
- Are Symptom Science/QOL studies eligible for BIQSFP funding?
- Are applications for studies associated with non-randomized trials eligible for BIQSFP funding?
- Are studies 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?
Preparing the BIQSFP Submission
- May several biomarker, imaging, and symptom science/QOL components be submitted on one checklist?
- Is there a page limit for the entire BIQSFP Proposal Package?
- What is the difference between the BIQSFP PI and the Lab Co-Investigator on the Checklist?
- 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 application for INTEGRAL BIQSFP study to be submitted?
- When is an application for INTEGRATED BIQSFP study 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 Cost Effective Analysis (CEA) studies eligible for BIQSFP funding?
No. CEA studies are no longer eligible for BIQSFP funding. NCI is exploring other mechanisms through which CEA studies may be supported, outside the BIQSFP program.
Are Symptom Science/QOL studies eligible for BIQSFP funding?
Symptom Science/QOL studies should be submitted to the Division of Cancer Prevention (DCP) for funding. Symptom Science/QOL proposals submitted to BIQSFP must include a letter from DCP indicating that the proposed costs exceed allowable DCP funding and that DCP has agreed that the study should be considered for BIQSFP funding.
Are applications for studies associated with non-randomized trials eligible for BIQSFP funding?
Yes. However, only applications for integral BIQSFP studies associated with NCTN treatment trials are eligible.
Can salary support be requested?
Yes. Funding for technical support and consultants can be requested if the costs are justified for the BIQSFP-associated efforts 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 statistician when the statistical analysis is adequately justified as a need beyond the normal analysis needed for the 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 (including costs already covered under the U10/UG1), nor the effort of the Principal Investigator (PI) of the parent clinical trial concept as this would be expected to be included in the NCTN/NCORP grants.
Travel costs, presentation 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 parent trial. It is recommended that these questions be discussed with CTEP or DCP Program Staff prior to submitting a BIQSFP application to determine eligibility.
In addition, collection of blood or biopsies, even if solely for research purposes, does not make a study REAL-TIME Integrated.
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.
May several biomarker, imaging, symptom science/QOL components be submitted on one checklist?
No. A separate Study Checklist and a separate PHS 398 Form/Budget Justification need to be submitted for each integral and integrated biomarker, imaging, and symptom science/QOL component for which BIQSFP funding is requested.
Is there a page limit for the entire BIQSFP Proposal Package?
No. There is no overall page limit for the Proposal Package. Although there is a five-page limit for each Biomarker, Imaging, and Symptom Science/QOL Concept Checklists, the page limit does not apply to the analytical validation report or publications of analytical validation, which should be submitted as an appendix. Also, applicants are encouraged to submit standard operating procedures (SOP) as an appendix when the SOP informs on precision, accuracy, and specificity needed for validation of the assay(s), imaging tests or symptom science/QOL assessment tools/instruments being proposed.
What is the difference between the BIQSFP PI and the Lab Co-Investigator on the Checklist?
The BIQSFP PI is the investigator who is leading the BIQSFP project. This is the investigator who has conceived and developed the BIQSFP project and/or represents the BIQSFP project team to outside entities. This may or may not be the investigator responsible for conducting the proposed assays, especially if multiple assays are proposed.
The Lab Co-Investigator is the person directly responsible for the actual conduct of the assays. This is the person directing the laboratory in which the assays will be performed. There may be multiple Lab Co-Investigators if there are multiple assays being performed in different labs.
Often the BIQSFP PI is the Lab Director, such that you would not have a separate BIQSFP PI and Lab Co-Investigator.
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 the 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 and INTEGRATED 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) as a primary outcome for integral study or secondary outcome for integrated study. This will become part of the protocol as well.
What do I submit to request consideration for BIQSFP funding?
All resources needed for the BIQSFP Application Package can be found on the BIQSFP website including the BIQSFP Guidelines, Frequently Asked Questions (FAQs), Concept Checklists, Budget/Budget Justification, and Program Contacts.
Is the signature of the Institutional business official needed at time of BIQSFP Proposal Package submission?
No. Institutional business official signature will be required once the final funding has been approved by NCI. BIQSFP applications that have been approved for funding must be officially submitted to NIH through grants.gov. Detailed instructions and a link to apply via the NIH ASSIST module can be found in the Funding Opportunity Announcement (FOA) https://grants.nih.gov/grants/guide/pa-files/PA-20-272.html.
When is an application for INTEGRAL BIQSFP study to be submitted?
Application for an INTEGRAL BIQSFP study must be submitted at the time the parent concept is submitted and will be evaluated by the steering committee at the time of the initial parent concept review. BIQSFP applications must be submitted to the respective Protocol Information Office (PIO) (CTEP or DCP PIO).
When is an application for INTEGRATED BIQSFP study to be submitted?
Application for an INTEGRATED BIQSFP study should be noted on the respective CTEP/NCORP Trial Concept Submission Form and the study needs to be included as a secondary objective and outcome of the trial.
REAL-TIME integrated BIQSFP proposals should be submitted following the notification to the PI of the approval of the parent concept by the respective CTEP/DCP PIO, preferably within 3 months of notification of approval.
NON-REAL TIME (NRT) integrated BIQSFP proposals are accepted only when submitted in response to a call for applications, which is issued by the NCI/CCCT based on funding availability.
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 of 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 after CTROC recommends the BIQSFP proposal 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.
What happens after my BIQSFP proposal is approved for funding?
After your BIQSFP proposal is approved for funding, you will be contacted by NCI to participate in a project kick-off call with NCI BIQSFP staff. The purpose of the call is to review how the trial and the BIQSFP project should be proceeding, and to ensure that the systems for specimen transfer, testing, return of test results are in place.
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.
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.
Whom do I contact if I have specific BIQSFP program questions?
Please see the BIQSFP Contacts Page