When is an INTEGRAL study application to be submitted?
INTEGRAL study applications must be concurrently submitted with the Parent Concept, to the respective PIO (CTEP or DCP Protocol Information Office).
When is an INTEGRATED study application to be submitted?
Beginning in 2014, INTEGRATED biomarker, imaging, and/or QOL studies along with CEA study applications must be submitted after parent concept approval and must be received within four months of PI/Study Team formal notification of the parent concept approval. The INTEGRATED study application should be submitted to the respective PIO (CTEP or DCP Protocol Information Office).
Should applicants indicate the options that they have considered for reducing the cost of assays/tests?
YES…NCTN group/NCORP investigators are encouraged to explore options for reducing the cost of assays and tests 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. 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. The evaluation of CEA paired with phase 3 clinical trials is the responsibility of the SSC’s. The Clinical and Translational Research Operating Committee (CTROC) makes the final funding recommendations.
Are study applications associated with phase 2 trials eligible for BIQSFP funding?
YES…however, Cancer Prevention, QOL and CEA studies associated with Phase 2 clinical trials are NOT eligible for BIQSFP funding..
Who evaluates and approves the BIQSFP proposals?
BIQSFP proposals are evaluated by the appropriate NCI Scientific Steering Committee (SSC). If no SSC exists, CTEP or DCP (as applicable) evaluate the proposals using existing procedures including outside expert ad hoc evaluators. Final prioritization and funding decisions on meritorious proposals are made by CTROC.
May a study application with several biomarker, imaging, QOL, & 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, or CEA component for which BIQSFP funding is requested.
What do I submit to request consideration for BIQSFP funding?
The BIQSFP Proposal Package includes a cover letter signed by the NCTN/CCOP Network/NCORP Chair 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 BIQSFP project(s).
− Brief description of the project(s) 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 Form PHS 398 (available on the BIQSFP website) along with a narrative justifying each requested cost.
Lastly, the Proposal Package includes 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).
Is the signature of the Institutional business official needed at time of BIQSFP Proposal Package submission?
NO... The signature of the institutional business official is no longer required at the time of initial submission of the total composite budgets. Institutional approval and sign-off will be required once the final funding has been approved by NCI.
Is there a page limit for the BIQSFP Proposal Package?
NO... but there is a five-page limit for each Biomarker, Imaging, and QOL Concept Checklist. In addition, there is an eight-page limit for the CEA Checklist. There is no overall page limit for the Proposal Package.
Should a description of the BIQSFP project(s) be included within the Parent Concept application?
YES…a description of the INTEGRAL and/or INTEGRATED proposal(s) requesting BIQSFP support must be embedded into the parent concept document. This will become part of the protocol as well.
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 evaluation and approval is completed once CTROC recommends the study for funding. Funding will be via an Administrative Supplement to the respective NIH U10 grant. In some cases, based on available funding, a contract may be established through Leidos Biomedical Research, Inc. (formerly 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.
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 funding does not support the effort of NCTN group/NCORP chairpersons or in general, the effort of the study PI of the parent clinical trial concept as this would be expected to be part of the NCTN/NCORP agreements.
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 assessments that are conducted as part of CEA may be included.
How does the process for the BIQSFP funding correlate with the OEWG Protocol approval guidelines/timelines implemented in early 2011?
The NCI Steering Committees (SSCs) 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.
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 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 2015 to this program.
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, although they involve screening of more than 100 patients, are intended to treat less than 100 patients.
- 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.
- Integrated studies submitted more than four months following NCTN/NCORP notification of parent concept approval.
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://biqsfp.cancer.gov/
Who do I contact if I have specific BIQSFP program questions?
For CTEP - Margaret Mooney, MD, Chief, Clinical Investigations Branch
Phone: 240-276-6560. Email: firstname.lastname@example.org
For DCP - Worta J. McCaskill-Stevens, MD, MS, Chief, Community Oncology and Prevention Trials Research Group, DCP
Phone 240-276-7075. Email: email@example.com
Ann O’Mara, PhD., Head, Palliative Care Research, DCP
Phone: 240-276-7050. Email: firstname.lastname@example.org
For CIP - Lalitha K. Shankar, MD, PhD, Chief, Clinical Trials Branch, Cancer Imaging Program, Division of Cancer Treatment and Diagnosis
Phone: 240-276-6510. Email: email@example.com
For BIQSFP Prioritization and Evaluation
Raymond Petryshyn, PhD, Program Director, Coordinating Center for Clinical Trials
Phone: 240-276-6160. Email: firstname.lastname@example.org
For Cost-Effectiveness Analysis (CEA)
O. Wolf Lindwasser, PhD, Program Director, Coordinating Center for Clinical Trials
Phone: 240-276-6160. Email: email@example.com
For Leidos Biomedical Research, Inc. Subcontracting Process
Geoff Seidel, RN, MS, Program Director, Coordinating Center for Clinical Trials
Phone: 240-276-6272. Email: firstname.lastname@example.org