TRANSPARENCY IN RWE - CAN WE NAVIGATE THE KEY CHALLENGES?
Author(s)
Moderator: Richard Willke, PhD, ISPOR, Lawrenceville, NJ, USA
Panelists: Shirley Wang, PhD, Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA; C. Daniel Mullins, PhD, Pharmaceutical Health Services Research, University of Maryland, School of Pharmacy, Baltimore, MD, USA; Andrew Bate, phD, Epidemiology, Pfizer, Dorking, Surrey, UK; Marc Berger, MD, Real World Data and Analytic, Pfizer, Inc., New York, NY, USA
Presentation Documents
This session will provide a brief overview of the RWE Transparency Initiative and then focus on several of the key challenges in moving it forward. These challenges include: establishing a protocol template this inclusive enough to be clearly specify the hypothesis(es) to be tested and the analytics to be used; the conditions needed to ensure trust that any prior analyses of the data in question did not provide prior information about the hypotheses being tested; and the external incentives that could help lead to registration of RWD study protocols, and the posting of their results, becoming common practice.
Conference/Value in Health Info
2019-11, ISPOR Europe 2019, Copenhagen, Denmark
Code
IP9