Funding of biomarker, imaging, quality-of-life (QOL), and cost-effectiveness analysis (CEA) studies by NCI.

Abstract

104 Background: NCI’s purpose for the Biomarker, Imaging, and QOL Studies Funding Program (BIQSFP) is to ensure that the most important, scientifically meritorious biomarker, imaging, QOL, and/or CEA studies can be initiated in a timely manner in association with NCI clinical trials. BIQSFP studies are embedded in selected large, randomized phase II treatment trial concepts with a control arm and an integral study(ies), along with integral and/or integrated studies associated with phase III treatment trials, cancer prevention trials, and primary symptom management trials. Methods: BIQSFP provides opportunities to enhance clinical outcomes by validating targets, reducing morbidity, predicting treatment effectiveness, identifying populations that may better benefit from treatment, improving clinical trial accrual and retention, and modifying standards of care. BIQSFP applications are accepted from NCI Cooperative Groups and Community Clinical Oncology Programs. Integral components must be performed in order for the trial to proceed. Integral studies have the highest funding priority. Integrated components are clearly identified as part of the clinical trial from the beginning, are intended to identify or validate (in the patient population of interest) assays/tests/QOL tools that are planned for use in future trials, are performed in real time, and include complete plans for specimen collection, laboratory measurements, and statistical analysis. Integrated studies in general should not be exploratory but rather should be designed to test a hypothesis, not simply to generate hypotheses. Results: Since 2009, 36 BIQSFP funding applications have been reviewed with most evaluations via NCI’s Scientific Steering Committees (http://ccct.cancer.gov/). Twenty studies have been approved for BIQSFP funding. Conclusions: BIQSFP information presented in the poster includes scope of activity, process for application and evaluation, and funded projects (http://biqsfp.cancer.gov/). Funded by NCI Contract No. HHSN261200800001E.