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

Welcome and Introduction to Workshop

• Arti Hurria, MD - City of Hope
  Geriatric Oncology Workshop (PDF - 474KB)
• Laura Levit, JD - American Society of Clinical Oncology
  Improving the Evidence Base for Treating Older Adults with Cancer (PDF - 231KB)
• Harpreet Singh, MD - U.S. Food and Drug Administration
  FDA Perspective: Regulatory Considerations for Treating Older Adults with Cancer  (PDF - 255KB)

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:

• Supriya Mohile, MD, MS - University of Rochester
  Designing Clinical Trials For Real-World Patients: Recommendations from the CARG/NIA/NCI U13 Conferences (PDF - 333KB)
• Tania Small, Novartis
• Hans Wildiers, MD, PhD - University Hospitals Leuven, Belgium
  Lessons from EMA (European Medicine Agency) (PDF - 864KB)
   

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:

• Bindu Kanapuru, MD - U.S. Food and Drug Administration
  Enrollment of older adults in Cancer clinical trials : US Food and Drug Administration Experience (PDF - 856KB)

• Lou Fehrenbacher, MD - Kaiser Permanente
  Modernizing Clinical Trial Eligibility (PDF - 113KB)

• Mihaela Popa McKiver, Bristol-Myers Squibb

• Eric H. Rubin, MD - Merck Research Laboratories
  Special Considerations for Cancer Drug Development in Older Adults (PDF -  162KB)

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:

• Sean Khozin, MD, MPH - U.S. Food and Drug Administration
  Improving clinical evidence generation with Real World Evidence (PDF - 2.94MB)
• Gary Lyman, MD, MPH, FASCO - Fred Hutchinson Cancer Research Center
  Leveraging research designs for real-world patients: Real-world evidence (PDF - 917KB)
• Robert S. Miller, MD, FACP, FASCO - ASCO CancerLinQ
  ASCO’s CancerLinQ®: Real-world insights to drive quality improvement and discovery (PDF -  1.45MB)

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:

• Peter C. Adamson, MD - The Children’s Oncology Group
  Pediatric Regulatory Landscape (PDF - 142KB)
• Susan L. Weiner, PhD - Children’s Cause for Cancer Advocacy
• Donna A. Messner, PhD - Center for Medical Technology Policy
  Improving Evidence in Geriatric Oncology Trials: A Role for Payers? (PDF - 65KB)
• Frans Opdam, Netherlands Cancer Institute
  EMA Perspectives on Regulatory Considerations in Treating Older Patients With Cancer (PDF - 630KB)