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Project Silver

Improving the Evidence Base for the Treatment of Older Adults with Cancer

Project Silver


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

Regulatory Policy

  • 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

Global Engagement

  • 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 

Select Events

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.

FDA Guidance Documents

Select Publications

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