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  4. FDA-ASCO PUBLIC WORKSHOP: 2020 Clinical Outcome Assessments in Cancer Clinical Trials Fifth Annual Workshop - 07/22/2020 - 07/17/2020
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Virtual | Virtual

Event Title
FDA-ASCO PUBLIC WORKSHOP: 2020 Clinical Outcome Assessments in Cancer Clinical Trials Fifth Annual Workshop
July 22 - 17, 2020

July 22 - 17, 2020

Twitter: #OCEOutcomes20 

Co-Sponsor: American Society of Clinical Oncology (ASCO)


  • U.S. Food and Drug Administration
    • Paul Kluetz, MD
      Deputy Director, Oncology Center of Excellence, FDA
  • American Society of Clinical Oncology
    • Kathryn F. Mileham, MD, FACP
      Chair, Cancer Research Committee, ASCO
    • Heidi Klepin, MD, MS
      Immediate Past Chair, Cancer Research Committee, ASCO
      Date: July 17, 2020 (Friday)
      Time: 9:00 am to 4:00 pm

Pre-Workshop Introduction Video

Please watch this video prior to the workshop, in which the co-chairs discuss the context and background for this year’s event.


Since the first COA-CCT meeting in 2015, our overarching goal has been to provide a forum for collaborative and productive multidisciplinary discussions to advance the understanding of the complex regulatory, health care policy, and scientific issues surrounding the use of patient-reported outcome (PRO) measures in cancer clinical trials. The specific goal of this meeting will be a detailed discussion for creating regulatory-grade patient-reported data on tolerability.

This year, the workshop will be fully virtual. To provide context for this meeting, a series of presentations will be published in the weeks prior to the meeting. The link to these presentations will be made available to registered attendees prior to July 17th.

In this workshop, we will consider a hypothetical case example of a trial in which the investigational arm is a tyrosine kinase inhibitor (TKI) and the control arm is traditional cytotoxic chemotherapy being investigated for an advanced/metastatic malignancy. Each session will focus on the specific issues associated with understanding patient-reported tolerability in the context of comparing differing therapeutic classes and to provide solutions to overcome these issues. Specifically, we will discuss unbiased item selection, assessment frequency, and a global side effect bother item. Finally, with the aim of creating data that is of high quality and informs tolerability in the regulatory context, we will discuss how this information can be included in the FDA OCEs new pilot Project Patient Voice. Project Patient Voice is web-based platform for patients and caregivers, along with their health care providers to look at patient-reported symptom data collected from cancer clinical trials.

Meeting Goals

  • To provide a forum for open discussion between academia, industry, international regulatory, and patient advocacy groups to advance measurement of the patient experience as it relates to tolerability in cancer clinical trials;
  • Consider how PRO instruments, assessment frequencies, and trial designs can be used to support product labeling regarding tolerability;
  • Engage key stakeholders to identify opportunities to overcome barriers to incorporation of PRO and discuss actionable next steps;
  • Discuss current FDA approaches to the analysis and review of PRO data, specifically PROs related to tolerability submitted to FDA to support cancer product applications; and
  • To receive feedback on Project Patient Voice pilot

Workshop Materials

Broadcast Replay


Joan Ferlo Todd, RN
Senior Regulatory Health Project Manager
Oncology Center of Excellence, (OCE)
Office of the Commissioner (OC)
U.S. Food and Drug Administration
10903 New Hampshire Ave, Silver Spring, MD 20993
Tel: 301.796.6079 

Caroline Schenkel, MSc
Manager, Research Analysis and Publications
Center for Research and Analytics (CENTRA)
American Society of Clinical Oncology
2318 Mill Road, Suite 800
Alexandria, VA 22314
Tel: 571-483-1605

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