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FDA-ASCO Public Workshop: Geriatric Oncology Workshop

Co-sponsored by the:

U.S. Food & Drug Administration (FDA) and the American Society of Clinical Oncology (ASCO)

Co-Chairs: 

Harpreet Singh, MD, FDA, CDER
Laura Levit, JD, Associate Director of Policy, ASCO

The Food and Drug Administration (FDA) and the American Society of Clinical Oncology (ASCO) will jointly convene a workshop on improving the evidence base for treating the geriatric oncology population. The representation of older adults in National Cancer Institute (NCI) and FDA registration trials has remained low, and there is limited safety and efficacy information reported on older adults.

The objective of the public workshop is to provide a forum to discuss the growing need to improve evidence generation in the geriatric population. At this workshop, we will:

  • Discuss the ASCO recommendations on improving the evidence base for treating older adults with cancer in response to a critical need identified by the Institute of Medicine (IOM)
  • Discuss the use of clinical trial and research designs and infrastructure for generating evidence on older patients with cancer
  • Discuss the role of the FDA in incentivizing research involving older adults with cancer
  • Discuss the use of journal policies to improve researchers’ reporting on age distribution and health risk profiles of research participants
  • Discuss strategies to increase clinicians’ recruitment of older adults with cancer to clinical trials
  • Discuss the utility of post marketing, “real world” data in generating data on safety outcomes in older adults with cancer

Date:

November 6, 2017

Time:

8:00 am - 5:00 pm

Location: 

FDA White Oak Campus
10903 New Hampshire Avenue
Building 31, Room 1503 - Great Room B & C
Silver Spring, MD 20993

Webcast Information:

FDA provided a free-of-charge, live webcast of the November 6, 2017 Geriatric Oncology Workshop. Recordings of the webcast can be found at the following links:

Meeting Information:

Contact:

Sonia C. Swayze, RN
Regulatory Health Project Manager
Oncology Program
Office of Hematology and Oncology Products
Center for Drug Evaluation and Research
Food and Drug Administration
Phone: 301.796.6132
E-mail: Sonia.swayze@fda.hhs.gov

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