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FDA/C-Path PRO Consortium: Second Annual Workshop on Clinical Outcome Assessments (COAs) in Cancer Clinical Trials

FDA/C-Path PRO Consortium: Second Annual Workshop on Clinical Outcome Assessments (COAs) in Cancer Clinical Trials

April 25, 2017

Location

Hyatt Regency Bethesda, Bethesda, Maryland

I. Background

Patient-focused drug development efforts are underway across therapeutic areas. Malignant hematology and oncology (cancer) is an active area of drug development where patient-centered measures of symptoms and function can add important data to inform the risks and benefits of cancer therapies. Unique issues exist in cancer clinical trials which make collection of patient-reported outcome (PRO) data challenging. The purpose of this workshop is to provide an open public forum for a broad representation of stakeholders to (a) discuss optimal methods to generate patient-focused data from cancer clinical trials and (b) review options for the measurement of patient-reported safety and tolerability.

The FDA and C-Path have expressed a willingness to leverage their combined strengths for the joint development of this workshop to improve the quality of patient-focused data in cancer clinical trials. The co-sponsors intend to engage with leaders in academia, industry, international regulatory and health technology assessment (HTA) bodies, and patient groups to thoughtfully discuss how to integrate PRO measures and other COAs into cancer clinical trials.

Goals and Objectives

  • Engage with leaders in academia, industry, international regulatory and HTA bodies as well as patient groups on COAs in cancer clinical trials.
  • Leverage expertise from multiple stakeholders in the PRO measurement development community.
  • Explore the use of PRO measures to better describe the tolerability of cancer therapies.

The Workshop intends to use a case-study approach with four sessions:

  • Safety vs Tolerability…Is there a difference? How do we define “tolerability’?
  • Assessing drug safety…Is there utility in a longitudinal approach to describing safety?
  • Integrating patients in the assessment of safety…What are approaches to the analysis and presentation of PRO-based symptomatic adverse event data?
  • Describing overall tolerability…What PRO measures exist to assess the overall effect of symptomatic adverse events on the patient experience?

Who Should Attend

This public workshop is intended for stakeholders interested in advancing COAs in cancer drug development including, but not limited to, academia, industry, regulatory agencies, consulting firms, HTA groups and patient groups.

Contact

Contact: Valerie Vashio at Valerie.vashio@fda.hhs.gov