Executive Summary

Overview: For the last 6 years, the CEO Roundtable on Cancer’s Project Data Sphere (PDS) has actively partnered with the FDA through a series of symposia focused on building consensus within the scientific community in support of advanced cancer research.  These Symposia have become a platform to discuss topics across policy & regulatory guidance, methods to advance oncology research, and patient advocacy.

The FDA and Project Data Sphere are energized by Symposium X’s theme on clinical trial data reuse. Our objective is to offer new ways to think about data sharing.  With a strong lineup of oncology and data experts from regulatory agencies, academia, and industry, participants will have the opportunity to interact with thought leaders in data sharing and reuse best practices.  COVID-19 and heightened public awareness of pharmaceutical development in clinical trials has set the stage to engage and advocate for more sharing and reuse of clinical research data and information.

Topic:  Data sharing & reuse of oncology clinical research data – policies and practices that enable greater access and utilization of patient level data.

Objective: Build consensus around methods, policies, and a clear understanding of actions as it relates to sharing clinical trial data.  This may include a deeper understanding of incentives and sustainable practices from regulatory, research, and implementation science perspectives.  Specifically, core objectives will include:

  • Bringing patient centricity into focus by making clinical trial data accessibility a common and standard practice across industry to maximize the value of patients’ participation.
  • Highlighting the regulatory and government perspective around policy implementation and incentivization to adopt innovative clinical trial designs leveraging historic data.
  • Noting the spectrum of behavior tied to clinical trial data sharing by industry and academia; identify how we can better balance incentives to maximize the utility of clinical trial.
  • Determining the most critical areas where greater access and reuse can have a significant impact for clinical research and ultimately patients.   Consider opportunities in pediatrics and rare diseases.
  • Learn from the disruption from, and response to COVID-19 to accelerate innovation in clinical research.

Welcome and Keynote Address

  • Dr. Bill Louv, PhD, President; Project Data Sphere
  • Donna R. Rivera, PharmD., MSc, Associate Director of Pharmacoepidemiology; US Food and Drug Administration (FDA)
  • Dr. Robert Califf, MD, MACC, Head of Clinical Policy and Strategy, Verily Life Sciences and Google Health

Panel 1: Routes to Yes

Moderator: Dr. Atul Butte, MD, PhD, Director; University of California, San Francisco (UCSF)

  • Panelist: Najat Khan, PhD, Chief Data Science Officer, Janssen R&D Data Sciences Global Head, Janssen R&D Strategy & Operations; Janssen Pharmaceutical Companies of Johnson & Johnson
  • Panelist: Dr. Harlan Krumholz, MD, SM, Harold H. Hines, Jr. Professor of Medicine; Yale School of Medicine
  • Panelist: Professor Steven Kern, PhD, Deputy Director, Quantitative Sciences; Bill & Melinda Gates Foundation

Panel 2: Sustainability Practices in Sharing and Reuse

Moderator: Dr. David Chambers, DPhil., Deputy Director for Implementation Science in the Office of the Director in the Division of Cancer Control and Population Sciences (DCCPS); National Cancer Institute (NCI)

  • Panelist: Dr. Frank Rockhold, PhD, Professor of Biostatistics and Bioinformatics; Duke Clinical Research Institute, Duke University Medical Center
  • Panelist: Dr. Jaime Guidry Auvil, PhD, Director, Office of Data Sharing; National Cancer Institute (NCI)
  • Panelist: Dr. Yili Pritchett, PhD, Vice President, Head of Biometrics; G1 Therapeutics Inc

Fireside Chat

Interviewer: Dr. Corrie Painter, PhD, Deputy Director; Count Me In, Broad Institute

  • Guest: Dr. Ned Sharpless, M.D., Director; National Cancer Institute (NCI)
  • Guest: Dr. David Fajgenbaum, MD, MBA, MSc, Assistant Professor of Medicine; University of Pennsylvania

Patient Power: The Untapped Resource for Accelerating Discovery

  • Sue Sherman, MHA, Executive Director & CEO; The LAM Foundation
  • Andrea Slattery, Director of Research; Symmetry Peak Management

Full Event Replay