BIQSFP '12 Frequently Asked Questions
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, and time horizon. 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. The evaluation of CEA paired with phase 3 clinical trials is the responsibility of the SSC's. CTROC makes the final funding recommendations.
Are Phase 2 trials eligible for BIQSFP funding?
YES…also the Revised BIQSFP Announcement expands BIQSFP eligibility to include integral AND integrated biomarker and imaging studies embedded in large (=100 patients), randomized phase 2 treatment trials. Phase 2 clinical trials with a CEA study are NOT eligible for BIQSFP funding.
Who reviews and approves the BIQSFP proposals?
BIQSFP proposals are evaluated by the appropriate Scientific Steering Committee (SSC). If no SSC exists, CTEP or DCP (as applicable) evaluate the proposals using existing procedures including outside expert reviewers. Final prioritization and funding decisions on meritorious proposals are made by the Clinical and Translational Research Operating Committee (CTROC).
Can BIQSFP funding be applied to a trial that is currently open?
GENERALLY NO, WITH RARE EXCEPTIONS…An example of an exception might be a new assay or imaging study that could significantly enhance the power of the study. Another example of an exception might be where there is a change in practice due to new knowledge or discovery. The exception would have to have great impact on the outcome of the study, a protocol amendment would be required, and sufficient accrual would need to be remaining on the parent trial to complete the proposed study.
May a proposal with several biomarker, imaging, QOL & CEA components be submitted on one checklist?
What do I submit to request consideration for BIQSFP funding?
The BIQSFP Proposal Package includes 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.
All BIQSFP proposals must include a budget at the time of submission that clearly details the costs (Direct and Indirect) for each of the biomarker, imaging, quality of life, and/or CEA proposals submitted. In addition, a total composite budget must be provided for the entire cost of the BIQSFP project. The budgets for the project should use the BIQSFP Cost Estimate Worksheet (available on the BIQSFP website) along with a narrative justifying each requested cost.
Lastly, the Proposal Package includes the parent trial concept (therapeutic, prevention, or symptom management) with the BIQ study embedded (for evaluation by SSCs or where appropriate, CTEP or DCP.
Is there a page limit for the BIQSFP Proposal Package?
YES…but only for the Biomarker/Imaging, QOL, and CEA Concept Checklists. There is a five-page limit for each Concept Checklist. Otherwise, there is no page limit on the Proposal Package.
Does the parent clinical trial concept need to be approved by the SSC prior to submitting the BIQSFP study?
NO…however, integral and integrated BIQSFP proposals should be submitted at the same time as the parent clinical trial concept.
Must the parent clinical trial concept be approved prior to BIQSFP review?
YES…The parent clinical trial concept must be approved before the BIQSFP proposal is considered for funding.
Should the application for BIQSFP funding be contained within the Concept submitted for the entire clinical trial?
YES…a description of the proposal requesting BIQSFP support must be embedded into the parent concept document. This will become part of the protocol as well. However, in addition to the concept, the BIQSFP submission package must contain a, cover letter, address the "Check List" and a budget(s) as described in the Announcement.
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 does not proceed simultaneously. The BIQSFP review and approval is completed once CTROC recommends the study for funding. A contract will be established through SAIC-Frederick on behalf of NCI prior to the opening of the trial. 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 (see #9).
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 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 funding does not fund the effort of Cooperative Group/CCOP chairpersons and in general, the effort of the study PI of the parent clinical trial concept as this would be expected to be part of the Cooperative Group agreement.
How does the process for the BIQSFP funding correlate with the OEWG Protocol approval guidelines/timelines implemented in early 2011?
The steering committees 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 (see below), timelines for development and activation of the parent protocols will be in accordance with the OEWG recommendations.
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 would be conducted in the future on stored specimens. BIQSFP supports biospecimen and tissue procurement, shipping costs, and 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 submission to determine eligibility.
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 2011.
What studies are ineligible for BIQSFP funding?
- Studies that do not meet the definitions for eligible trials [e.g., phase 1 concepts, small (<100 patients) randomized & all non-randomized phase 2 concepts, studies involving toxicity screens on animals].
- Studies that are still within the discovery phase or pre-clinical development stage focusing on assay development.
- Studies that can be conducted in the future on stored specimens (retrospective studies), except if the results are critical to the stated primary or secondary objectives of the trial.
- Studies eligible for DCP Cancer Credits.
- Cohort studies, screening studies, or longitudinal observational studies.
- Studies that include assays, tests, or tools that are standard of care and normally reimbursed by third-party payers.
We're completing our BIQSFP-funded protocol and preparing for publication of the findings. How do we cite the BIQSFP funding we've 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/aboutnci/organization/ccct/funding/biqsfp
Who do I contact if I have specific BIQSFP program questions?
For CTEP - Margaret Mooney, M.D., Chief, Clinical Investigations Branch (Phone: 301-496-2522. Email: email@example.com)
For DCP - Worta J. McCaskill-Stevens, MD, MS, Acting Chief, DCP (Phone 301-496-8541. Email: firstname.lastname@example.org); Ann O’Mara, Ph.D., Program Director Community Oncology and Prevention Trials Research Group (Phone: 301-496-8541. Email: email@example.com)
For CIP - Lalitha K. Shankar, MD, PhD, Chief, Clinical Trials Branch, Cancer Imaging Program, Division of Cancer Treatment and Diagnosis (Phone: 301-496-9531. Email: firstname.lastname@example.org)
For questions on Prioritization and Evaluation - Raymond Petryshyn, Ph.D., Program Director, Coordinating Center for Clinical Trials (Phone: 301-594-1216 Email: email@example.com)
For questions regarding the subcontracting process - Geoff Seidel, RN, MS, Program Director, Coordinating Center for Clinical Trials (Phone: 301-496-5748. Email: firstname.lastname@example.org)
For questions regarding the subcontracting process - O. Wolf Lindwasser, Ph.D., Program Director, Coordinating Center for Clinical Trials (Phone: 301-443-6792. Email: email@example.com)