Project Silver
Improving the Evidence Base for the Treatment of Older Adults with Cancer
Purpose
Project Silver is a public health initiative established by the FDA Oncology Center of Excellence (OCE) to increase representation of older adults (65 years and older) in cancer clinical trials with the goal of improving their treatment, care, and outcome through evidence-based data. Adults 65 years and older are a growing segment of the oncology population. Adequate representation of older adults who share a disproportionate burden of the cancer disease will allow generalizability of trial results, which can then be conveyed to patients and healthcare providers.
Goals
- Encourage sponsors to conduct inclusive and representative trials early in development.
- Engage with stakeholders to assess opportunities to improve clinical trial enrollment.
- Identify inclusive clinical trial opportunities including decentralized trials, etc.
Meet the Team
Project Lead: Bindu Kanapuru, MD, Associate Director for Cancer in Older Adults, Oncology Center of Excellence
Project Management: Pamela Balcazar, MS, Sr. Health Scientist, Oncology Center of Excellence
FDA Guidance Documents
- Inclusion of Older Adults in Cancer Clinical Trials
- Enhancing the Diversity of Clinical Trial Populations — Eligibility Criteria, Enrollment Practices, and Trial Designs
- Cancer Clinical Trial Eligibility Criteria: Patients with HIV, Hepatitis B Virus, or Hepatitis C Virus Infections
- Cancer Clinical Trial Eligibility Criteria: Patients with Organ Dysfunction or Prior or Concurrent Malignancies
- Guideline for the Study of Drugs Likely to be Used in the Elderly
- E7 Studies in Support of Special Populations; Geriatrics; Questions and Answers
- Studies in Support of Special Populations: Geriatrics ICH-E7
- Geriatric Information in Human Prescription Drug and Biological Product Labeling
Select Publications
- Singh H, Kanapuru B, Smith C, Fashoyin-Aje L, Myers A, Kim G, Pazdur R. FDA analysis of enrollment of older adults in clinical trials for cancer drug registration: A 10-year experience by the U.S. Food and Drug Administration. J Clin Oncol 2017 35:15.
- Kanapuru B, Singh H, Myers A, Beaver J, Kwitkowski V, Farrell A, Pazdur R. Enrollment of Older Adults in Clinical Trials Evaluating Patients with Hematologic Malignancies - the Food and Drug Administration (FDA) Experience. Blood Vol 130 Supplement 1, 2017.
- Levit LA, Singh H, Klepin HD, Hurria A. Expanding the Evidence Base in Geriatric Oncology: Action Items From an FDA-ASCO Workshop. JNCI 2018 Nov 1;110(11):1163-1170.
- Kanapuru B, Singh H, Kwitkowski V, Blumenthal G, Farrell AT, Pazdur R. Older adults in hematologic malignancy trials: Representation, barriers to participation and strategies for addressing underrepresentation. Blood Rev 2020 Sept;43:100670.
- Singh H, Beaver JA, Kim G, Pazdur R. Enrollment of older adults on oncology trials: An FDA perspective. J Geriatr Oncol. 2017 May;8(3):149-150.
- Improving the Evidence Base for Treatment Decision Making for Older Adults with Cancer: Proceedings of a Workshop—In Brief. The National Academies Press.
Further Information