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Session 8: Partnering with Patients in Clinical Trials: Follow-up from the 2014 SCT/FDA QSPI Workshop
Session Chair(s)
John Scott, PHD, MA
Division Director, Office of Biostatistics, CBER
FDA, United States
Michael Hale, PHD
VP, Head of Biostatistics & Programming
Shire, United States
In December, 2014, the Society for Clinical Trials and the FDA co-sponsored a workshop on the theme of Innovations in the Science and Practice of Clinical Trials. A multidisciplinary group of presenters and attendees discussed wide-ranging topics including small clinical trials for rare diseases, large trials for rare events, streamlining trial operations, wearable technology and other methodological innovations, and leveraging information from diverse data sources. The topic that seemed to engage the audience the most was the discussion of patient partnerships in clinical trials; increasingly patients may be more active contributors in the objectives, design, and conduct of trials, well beyond a traditional test subject role. Two speakers will provide examples of patient partnerships, and then a panel will discuss next steps to increase patient engagement in the clinical trial enterprise, and how statisticians can help and learn from patients.
Speaker(s)
Speaker
Veronica Todaro, MPH
Parkinson's Foundation, United States
Chief Operating Officer
Speaker
Martin Ho, PHD, MS
Google, United States
Head of Biostatistics
Speaker
Telba Irony, PHD, MS, MSC
Janssen R&D, United States
Senior Scientific Director, Quantitative Sciences
Panelists
Bennett Levitan, MD, PHD
Johnson & Johnson, United States
Executive Director, Benefit-Risk Assessment / Epidemiology
Aloka Chakravarty, PHD
Office of Data, Analytics, & Research, Office of the Commissioner, FDA, United States
Director, Data Analytics
Sara L. Eggers, PHD
FDA, United States
Director, Decision Support and Analysis Team, OSP, CDER