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 base data.
Why is this important?
Clinical trials are the key step in advancing potential new cancer treatments from the research setting to the cancer care clinic. Differences may exist between younger and older patients in drug response and toxicity. Also, older adults often have several health conditions requiring medications that could impact efficacy or the incidence and severity of adverse events.
Adults 65 years and older are a growing segment of the oncology population. Cancer incidence is expected to increase by 67% from 2010 to 2030 in people age 65 and older. Given the aging U.S. population, it’s particularly important now more than ever to ensure that older adults are also enrolling in cancer clinical trials. 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 health care providers.
However, older adults—particularly adults 75 years and older—have been historically underrepresented in clinical trials.
Project Silver Initiatives
- Encourage sponsors to conduct inclusive and representative trials early in development
- Evaluate regulatory submissions for data in age subgroups
- Consider need for additional data post approval
- Develop Guidance for Industry
Science and Research
- Actively engage in scientific collaboration with clinicians, social scientists and statisticians across FDA
- Evaluate geriatric assessment tools and other measures for physiologic age
- Foster opportunities for FDA oncology reviewers related to geriatric oncology
- Engage with global regulatory agencies to identify global strategies to increase evidence base for older adults
- Collaborate with global regulatory agencies through Project Orbis on review of demographic age subgroup information in applications and prescribing information
Advocacy and Outreach
- Engage with patient advocacy groups to assess opportunities to improve clinical trial enrollment
- Identify inclusive clinical trial opportunities including decentralized trials, etc.
- Engage with older adults to understand treatment goals and outcomes
Meet the Team
Project Lead: Harpreet Singh, MD, Associate Director, Oncology in Older Adults and Special Populations, Oncology Center of Excellence
Clinical Team Lead: Bindu Kanapuru, MD, Division of Hematological Malignancies II, Office of Oncologic Diseases, Center for Drug Evaluation and Research
Project Management: Pamela Balcazar, MS, Health Scientist, Oncology Center of Excellence
FDA has sponsored multiple public workshops to further engage with the stakeholders and the broader community on the importance of diverse representation in cancer clinical trials.
- November 6, 2017: FDA-ASCO Public Workshop: Geriatric Oncology Workshop | FDA
- Part 1 January 22, 2021, Part 2 January 25, 2021, Part 3 January 27, 2021: Improving the Evidence Base for Treatment Decision Making for Older Adults with Cancer A Workshop | National Academies
- March 23, 2021: Roadmap to 2030 for New Drug Evaluation in Older Adults - 03/23/2021 - 03/23/2021 | FDA
FDA Guidance Documents
- Inclusion of Older Adults in Cancer Clinical Trials (March 2020)
- 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
- Studies in Support of Special Populations: Geriatrics ICHE7
- Geriatric Information in Human Prescription Drug and Biological Product Labeling Guidance for Industry
- Harpreet S., Kanapuru B., Smith Che, Fashoyin-Aje L., Myers A., Kim G., and 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. Journal of Clinical Oncology 2017 35:15_suppl, 10009-10009
- Kanapuru B., Harpreet S., Myers A., Beaver, J., Kwitkowski, V., Farrell, A., and Pazdur, R. Enrollment of Older Adults in Clinical Trials Evaluating Patients with Hematologic Malignancies - the Food and Drug Administration (FDA) Experience Blood, Volume 130, Supplement 1, 2017, Page 861
- Levit LA, Singh H, Klepin HD, Hurria A. Expanding the Evidence Base in Geriatric Oncology: Action Items From an FDA-ASCO Workshop J Natl Cancer Inst. 2018 Nov 1;110(11):1163-1170. doi: 10.1093/jnci/djy169.
- 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 Sep;43:100670. doi:10.1016/j.blre.2020.100670
- 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. doi: 10.1016/j.jgo.2016.11.001. Epub 2016 Dec 23
- Improving the Evidence Base for Treatment Decision Making for Older Adults with Cancer: Proceedings of a Workshop – in Brief \ Improving the Evidence Base for Treatment Decision Making for Older Adults with Cancer: Proceedings of a Workshop-in Brief \ The National Academies Press nap.edu