FDA Workshop: 7th Annual Clinical Outcome Assessment in Cancer Clinical Trials Workshop

Meeting Registration: https://www.surveymonkey.com/r/COACCT22External Link Disclaimer

Twitter: #OCEOutcomes22

Background

The U.S. Food and Drug Administration (FDA) Oncology Center of Excellence (OCE) Patient-Focused Drug Development (PFDD) team welcomes you to the Clinical Outcome Assessment in Cancer Clinical Trials (COA-CCT) seventh annual workshop.

The overarching aim of this year’s workshop remains the same as in past years – 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 workshop will be open to the public, fully virtual, and will include an extremely knowledgeable and diverse group of panelists. During the three sessions of this workshop, we will focus our discussions on regulatory-grade patient-generated data and consider how collection of PROs can be affected by patients knowledge of their treatment while participating in cancer trials.

Session 1: Exploring the realities of open-label trials in oncology and use of PROs

In the opening session, we will discuss the importance and context of collecting PROs in cancer trials, specifically rare cancers and pediatric cancers. We will consider how PROs can be collected in an informative way and can serve as complementary data regardless of study design.

Session 2: Analysis and interpretation of PRO data from open-label cancer trials

In the second session, we will discuss ways in which we can analyze patient-generated results to examine whether knowledge of treatment had an effect.

Session 3: Efforts to advance PRO to inform tolerability regardless of blinding status in oncology

For the final session, we will discuss specific examples of how PRO data from open-label trials have been communicated to patients and providers, and highlight how descriptive tolerability has been helpful in these cases.

Meeting Goals

• Provide a forum for open discussion between regulators, academia, international experts, and patient advocates to advance measurement of the patient experience in open-label cancer clinical trials;
• Engage key stakeholders to identify opportunities to overcome barriers to incorporating measurement of PROs in open-label cancer trials and discuss actionable next steps;
• Discuss current FDA approaches to the analysis and review of PRO data in open-label cancer trials;
• Consider ways in which patient-reported tolerability data can be communicated, for example inclusion in FDA OCE’s pilot Project Patient Voice | FDA

Workshop Materials

• Agenda
• Biographies
• Background Reading
  • Does knowledge of treatment assignment affect patient report of symptoms, function, and health status? An evaluation using multiple myeloma trials (2021)
  • FDA review summary of patient-reported outcome results for ibrutinib in the treatment of chronic graft versus host disease (2020)

For past COA-CCT workshops, go to FDA OCE Patient-Focused Drug Development Program  and click “Past and Upcoming Events”.