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Session 3: Endpoints and PROs
Session Chair(s)
Steve Wilson, PHD
Senior Staff Fellow, OB, OTS, CDER, FDA, United States
Laura Lee Johnson, PHD
Director, Division of Biometrics III, Office of Biostatistics, OTS, CDER, FDA, United States
FDA’s effort to foster patient-focused drug development has several elements statisticians can leverage reaching from what was done in the past to where we see drug development moving. Three examples will be introduced and discussed. FDA’s new Pilot Clinical Outcome Assessment (COA) Compendium collates and summarizes COA information for many different diseases and conditions into a single resource intended to facilitate communication and be used as a starting point for early drug development. CPATH’s PRO Consortium and other consortia are working to fill critical measurement gaps with patent centric tools that will be used as primary and secondary endpoints in future clinical trials. PEDSnet is a multi-specialty pediatric learning health system including several of the United States’ largest children’s hospital health systems and is organized to quickly and inexpensively address important research questions using real world data and common data models.
Speaker(s)
Nikunj B. Patel, PHARMD
Director, Patient Reported Outcomes (Oncology) - Global Medical Affairs, AstraZeneca, United States
COA Compendium Pilot: An Update for Statisticians
Charles Bailey, MD, PHD
Assistant Professor of Clinical Pediatrics; Perelman School of Medicine, Children's Hospital of Philadelphia Research Institute, United States
Using COAs from Electronic Health Records in Pediatric Clinical Care and Clinical Research
Laura Lee Johnson, PHD
Director, Division of Biometrics III, Office of Biostatistics, OTS, CDER, FDA, United States
PRO Consortium Activities Involving and Impacting Statistical Analyses in Trials
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