How Sure Are You? A discussion with Prof. Steven Goodman on the epistemology of clinical research and DA
SDP Free Webinar
19 Jun, 2019 | 8:00 am PT / 11:00 am ET
Speaker: Steven Goodman, Associate Dean of Clinical and Translational Research and Professor of Medicine and of Health Research & Policy, Stanford University.
Moderator: WIlliam Leaf-Hermann, Senior Principal in Consulting Services, IQVIA.
The conclusions of clinical research are commonly reported with a “p-value” to help communicate the statistical significance of the results. However, the relationship between the p-value of a study which tests the efficacy of a new therapy and the likelihood that the therapy will provide benefit is frequently misunderstood. Concepts used in decision analysis, such as Bayesian analysis, may provide a more transparent interpretation of clinical research. A first step in helping drive adoption of such concepts is to understand the gulf between the DA community and the mindset of most clinical researchers and regulatory authorities.
Steven Goodman, MD, MHS, PhD is Associate Dean of Clinical and Translational Research and Professor of Medicine and of Health Research & Policy, directing Stanford's CTSA training programs in medical research methods and serving as chief of the Division of Epidemiology. He has been a senior statistical editor of Annals of Internal Medicine since 1987 and was Editor of Clinical Trials: Journal of the Society for Clinical Trials from 2004-2013. He is Vice-chair of the Methodology Committee of the Patient Centered Outcomes Research Institute (PCORI) and since 2004 has been scientific advisor for the national Blue Cross–Blue Shield Technology Assessment Program. He has served on numerous Institute of Medicine committees, including a 2014 committee on clinical trial data sharing. From 1989-2011, Steven was on the faculties of the Johns Hopkins Schools of Medicine and Public Health.
William Leaf-Herrmann, IQVIA
William Leaf-Herrmann, a Senior Principal in Consulting Services at IQVIA, has more than 25 years of experience as a business strategist in the life sciences, automotive, chemical, and financial services industries. He specializes in strategy development and portfolio management for clients in the pharmaceutical and biotechnology industries. With expertise spanning R&D and commercial strategy, William has consulted on both corporate and product-level strategy, leading engagements in Europe, Asia, and North America. Prior to IQVIA, William was a partner in the Life Sciences Practice of Strategic Decisions Group. William holds a PhD in physics from Harvard University and was a Churchill Scholar at the University of Cambridge. He is a Fellow of the Society of Decision Professionals.