Drugs

Presentations and Discussion Questions for FDA-ASCO Public Workshop: Geriatric Oncology

Welcome and Introduction to Workshop

Session 1: Designing clinical trials for older adults with cancer

Questions for discussion

  • What clinical trial designs should be used to expand the evidence base for older adults with cancer?
  • When should these trial designs be utilized during the approval process (pre-and/or post-market)?
  • What geriatric oncology endpoints should be included in clinical trial design? How should these endpoints be incorporated into the regulatory process and labeling?
  • What are potential mechanisms to fund clinical trials that enroll more older adults?
  • What concrete next steps should we take?

Moderator: Harvey Cohen, MD - Duke University

Speakers:

Session 2: Increasing the enrollment of older adults on FDA registration trials to reflect the proportion with the disease: Strategies and challenges

Questions for discussion

  • What is the role of each stakeholder (FDA, industry, academics, community) in overcoming barriers to clinical trial enrollment?

  • What other stakeholders need to be engaged?

  • How can we maximize adoption of eligibility criteria recommendations to increase enrollment of older adults to clinical trials?

  • What circumstances facilitate successful enrollment of older adults?

  • What concrete next steps should we take?

Moderator: Heidi Klepin, MD, MS - Comprehensive Cancer Center of Wake Forest University

Speakers:

Session 3: Leveraging research designs for real-world patients: Real-world evidence

Questions for discussion

  • How best can we maximize the partnership FDA and ASCO CancerLinQto answer important questions about novel cancer therapeutics in older adults?
  • How can industry participate in gathering and disseminating RWE on novel cancer therapeutics in older adults?
  • How can RWE evidence be incorporated into the regulatory process to gather more information on older adults with cancer? (Pre-market vs post market setting)
  • What concrete next steps can we take?

Moderator: Harpreet Singh, MD - U.S. Food and Drug Administration

Speakers:

Session 4: Lessons from pediatrics, payers, and the European Medicines Agency

Questions for discussion

  • What lessons can we learn from the pediatric experience (PREA & BPCA) and how can that inform future legislative and advocacy opportunities in geriatrics?
  • What can we learn from initiatives within EMA and potential applications in the drug approval process for the FDA?
  • How can reimbursement policy be leveraged to gather evidence related to the treatment of older adults with cancer?
  • What concrete next steps can we take?

Moderator: Arti Hurria, MD - City of Hope

Speakers:

 

Page Last Updated: 01/02/2018
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