返回 Agenda
Session 9:Unhealthy Safety Assessment: Moving Towards Better Characterization of Patient Harms
Session Chair(s)
Mat Soukup, PhD
Deputy Director, Division of Biometrics VII, OB, OTS CDER
FDA, United States
Brenda Crowe, PhD
Associate Vice President, Statistics
Eli Lilly and Company, United States
Frank W. Rockhold, PhD, MSc
Professor of Biostatistics
Duke Clinical Research Institute, Duke University Medical Center, United States
The amount of information collected in clinical trials is weighted more to safety than benefit; however, a disproportionate number of statisticians are involved in assessing the benefits of a pharmaceutical product relative to the number of statisticians assessing the risks. This is also reflected in the literature around new medicines. It is important for there to be a statistical presence in the evaluation of safety as the questions can be complex and require novel statistical solutions; even in simple cases, such as calculating rates across trials, a lack of statistical presence has resulted in inadequate and improper approaches being utilized.
Learning Objective : At the conclusion of this session, participants should be able to:- Understand common clinical issues that arise when characterizing the safety (and benefit-risk) of a pharmaceutical product
- Identify the rationale and motivation for an increased statistical presence in assessing risks
- Apply good statistical practice for safety related topics
Speaker(s)
Unhealthy Safety Assessment: Moving Towards Better Characterization of Patient Harms
Christopher B. Granger, MD
Duke University Medical Center, United States
Professor of Medicine; Director, Cardiac Intensive Care Unit
Estimands and the Analysis of Adverse Events in the Presence of Varying Follow-Up Times Within the Benefit Assessment of Therapies
Steffen Unkel
University Medical Center Göttingen, Germany
Department of Medical Statistics
Improved Characterization of Patient Harms: A Regulatory Perspective
Peter Stein, MD
Peter Stein Consulting, LLC, United States
Consultant