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Incorporating PRO data to optimize dose in anti-cancer therapies

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Organized By: Industry SIG

Exposure-response (E-R) analysis to inform optimal dose in early clinical development of oncology products has traditionally relied on adverse event-based clinician-reported Common Terminology Criteria for Adverse Events. As part of a broader effort to improve dose optimization in cancer drug development, FDA is exploring inclusion of patient-reported outcome (PRO) data into E-R analysis. Rigorous systematic assessment of symptomatic AEs using well-developed PRO instruments could expand available data used to evaluate drug exposure and related toxicity from a patient perspective. This PRO-based approach may be beneficial in complementing traditional safety assessment with a goal to improve current dose selection strategies. The purpose of this webinar is to provide an overview on the FDA’s draft guidance on core PROs in cancer clinical trials, to discuss how PRO-based E-R methods could complement traditional E-R analysis, to discuss development of PRO-based E-R methods, and to hold a live question and answer session on this topic between the speakers and webinar participants.

Audience Benefits:
  • The audience will learn about FDA’s new draft guidance on core PROs in cancer clinical trials 
  • The webinar will introduce the audience to the use of PRO symptom libraries to assess expected symptomatic side effects and their impact on patients receiving anti-cancer agents 
  • The audience will better understand how PRO’s could be used to support dose selection strategies in early product development

Learning Outcomes/Objectives
After the webinar, the learner will be able to:
  • Gain further insights into FDA’s thinking related to core PROs in oncology product development
  • Review existing PRO item libraries to assess expected side effects and understand the importance of trial design considerations in this context including objective item selection, appropriate assessment frequency, and mitigation of missing data
  • Explain how inclusion of PRO’s into early clinical development can inform exposure-response analysis to complement traditional adverse events-based exposure-response analysis

  • Paul G. Kluetz, MD, Deputy Director, U.S. Food and Drug Administration, Oncology Center of Excellence
  • Vishal Bhatnagar, MD, Associate Director for Patient Outcomes, U.S. Food and Drug Administration, Oncology Center of Excellence
  • Jeanne Fourie Zirkelbach, PhD, Lead Pharmacologist, U.S. Food and Drug Administration, Center for Drug Evaluation and Research, Office of Clinical Pharmacology
  • Patricia Corey-Lisle, PhD, Global Head Patient Centered Outcomes, Genentech Inc.

  • Moderator:
  • Päivi H. Miskala, MSPH PhD, Independent Researcher/Retired

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