Teaching Clinical Trials to Nonstatisticians

• Activity Number: 682
• Type: Topic Contributed
• Date/Time: Thursday, August 8, 2013 : 10:30 AM to 12:20 PM
• Sponsor: Section on Teaching of Statistics in the Health Sciences
• Author(s): Richard Holubkov*+ and Susan Elizabeth Telke*+ and Christopher Assaid*+ and Marianne Bertolet
• Companies: Univ of Utah Pediatrics and University of Minnesota - Twin Cities and Merck & Co and University of Pittsburgh
• Keywords: teaching ; clinical trials ; medical statistics

Abstract

Clinical trials can be a difficult class, especially for students who are nonstatisticians. In this session, we will discuss challenges and potential solutions drawn from our expertise in working with students in the clinical and translational sciences, public health, medicine, and the pharmaceutical industry. Topics include protocol development, optimum selection of patients, masking, adaptive designs, randomization schemes, the nature and importance of intent-to-treat methods, reporting efficacy and futility, communicating with Data Safety Monitoring Boards, and reporting results. We will also discuss the advantages and disadvantages of teaching online vs. face-to-face, using real-life examples and examples from "classic" clinical trials articles, and using active learning and case studies.