You are cordially invited to the ASA Biopharmaceutical Section webinar on
Pragmatic Benefit:Risk Evaluation: Using Outcomes to Analyze Patients Rather than Patients to Analyze Outcomes given by
Dr. Scott Evans on
Thursday, October 18, 2018, 12:00 p.m. – 2:00 p.m. Eastern time.
Details and registration can be found at www.amstat.org/ASA/Education/Web-Based-Lectures.aspx
Registration Deadline: Tuesday, October 16, at 12:00 p.m. Eastern time
Description:
Randomized clinical trials are the gold standard for evaluating the benefits and risks of interventions. However these studies often fail to provide the necessary evidence to inform practical medical decision-making. The important implications of these deficiencies are largely absent from discourse in medical research communities.
Typical analyses of clinical trials involve intervention comparisons for each efficacy and safety outcome. Outcome-specific effects are tabulated and potentially systematically or unsystematically combined in benefit:risk analyses with the belief that such analyses inform the totality of effects on patients. However such approaches do not incorporate associations between outcomes of interest, suffer from competing risk challenges, and since efficacy and safety analyses are conducted on different analysis populations, the population to which these benefit:risk analyses apply, is unclear.
This deficit can be remedied with more thoughtful benefit:risk evaluation with a pragmatic focus in future clinical trials. Critical components of this vision include: (i) using outcomes to analyze patients rather than patients to analyze outcomes, (ii) incorporating patient values, and (iii) evaluating personalized effects. Crucial to this approach entails improved understanding of how to analyze one patient before analyzing many. Newly developed approaches to the design and analyses of trials such as partial credit and the desirability of outcome ranking (DOOR), are being implemented to more optimally inform patient treatment.
Speaker Bios:
Dr. Scott Evans is a tenured Professor of Epidemiology and Biostatistics and the Director of the George Washington Biostatistics Center.
Professor Evans interests include the design, monitoring, analyses, and reporting of and education in clinical trials and diagnostic studies. He is the author of more than 100 peer-reviewed publications and three textbooks on clinical trials including Fundamentals for New Clinical Trialists. He is the Director of the Statistical and Data Management Center (SDMC) for the Antibacterial Resistance Leadership Group (ARLG), a collaborative clinical research network that prioritizes, designs, and executes clinical research to reduce the public health threat of antibacterial resistance.
Professor Evans is a member of the Board of Directors for the American Statistical Association (ASA) and the Society for Clinical Trials (SCT) and is a former member of the Board for the Mu Sigma Rho (the National Honorary Society for Statistics). He is a member of an FDA Advisory Committee, the Steering Committee of the Clinical Trials Transformation Initiative (CTTI), and serves as the Chair of the Trial of the Year Committee of the SCT.
Professor Evans is the Editor-in-Chief of CHANCE and Statistical Communications in Infectious Diseases (SCID), and the Co-Editor of a Special Section of Clinical Infectious Diseases (CID) entitled Innovations in Design, Education, and Analysis (IDEA).
Dr. Evans is a recipient of the Mosteller Statistician of the Year Award, the Robert Zackin Distinguished Collaborative Statistician Award, and is a Fellow of the ASA, SCT, and IDSA.
Registration Fees:
Biopharmaceutical Section Members: $0
ASA Members: $59
Nonmembers: $74
Each registration is allowed one web connection. Sound is received via audio streaming from your computer's speakers. Multiple persons are encouraged to view each registered connection (for example, by projecting the webinar in a conference room).
Register
Access Information
Registered persons will be sent an email the afternoon of Tuesday, October 16, with the access information to join the webinar and the link to download and print a copy of the presentation slides.
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Wei Zhang
Mathematical Statistician
FDA
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