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  4. Public Workshop: In-person and Hybrid How Much is Enough? Trial Designs for Treatment Regimens with Multiple Phases - 05/09/2024
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Workshop | In Person

Event Title
Public Workshop: In-person and Hybrid How Much is Enough? Trial Designs for Treatment Regimens with Multiple Phases
May 9, 2024


Date:
May 9, 2024
Time:
9:00 AM - 4:00 PM ET

Background

The purpose of this one-day public workshop is to provide an interdisciplinary forum to discuss the best practices of trial design, analyses, and interpretation of trials with multiple phases of treatment (e.g., resectable lung cancer, early-stage breast cancer). The goal is to foster robust scientific discussion to explore approaches to address uncertainty in interpretation of the several high-profile clinical trials which contain regimen approaches, which do not isolate the contribution of each phase to the regimen. Ideally, this workshop will advance methods to incorporate multiple arms when it is feasible and reasonable in trials with multiple phases of a regimen. Additionally, this will build on a previous AACR/FDA workshop on overall survival. We will explore considerations for the assessment and interpretation of overall survival in early-stage trials with regimen approaches, where long term overall survival is a critical variable.

Meeting Goals

  • Discuss key “best practices” in clinical trial design of trials with multiple phases, often in the early stages of disease (therapy before and after surgery and therapy during and after chemoradiation including duration).
  • Identify best practices in terms of control arms for future trials in resectable cancers.
  • Discuss add on designs in resectable cancers, particularly non-small cell lung cancer (NSCLC) given differential approvals in neoadjuvant, adjuvant, and peri-operative trials.
  • Identify “best practices” for incorporation of other safety information into the benefit-risk assessment, such as deaths, adverse events, and drug tolerability for adjuvant and peri-operative regimens.
  • Discuss best practices for assessment of patient burden in terms of long-term toxicity potential overtreatment.

Meeting Information

This is an in-person/virtual hybrid event that will take place at the Bethesda Marriott located on 5151 Pooks Hill Road in Bethesda, MD 20814.

To register, visit REGISTER HERE Visit the workshop website for additional information.

Workshop Materials

  • Agenda here
  • Biographies here

Contacts

  • Rukiya Umoja, PharmD, RPh
    Associate Director, Regulatory Science and Policy
    Office of Science Policy and Government Affairs
    American Association for Cancer Research
    1401 H Street, NW, Suite 740 | Washington, DC 20005
    215-309-4350
    Rukiya.umoja@aacr.org
  • Angela James, MSN, RN
    Health Scientist
    Oncology Center of Excellence (OCE)
    Office of the Commissioner (OC)
    U.S. Food and Drug Administration
    10903 New Hampshire Ave | Silver Spring, MD 209903
    202-317-0312
    Angela.james@fda.hhs.gov
  • Toneisia Gross, MS, BSN, RN
    Health Scientist
    Oncology Center of Excellence (OCE)
    Office of the Commissioner (OC)
    U.S. Food and Drug Administration
    10903 New Hampshire Ave | Silver Spring, MD 209903
    301-272-7658
    Toneisia.Gross@fda.hhs.gov

 

 
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