Clinical Trials Seminar Series Announcement: “Conclusions and Decisions from Trial Endpoints”

Clinical Trials Seminar Series

Presented by: Design, Biostatistics and Ethics Support and Training (DBEST)

“Conclusions and Decisions from Trial Endpoints”

Presenter:

David Jarjoura, Ph.D.

Director, Center for Biostatistics

Research Professor, Division of Biostatistics, College of Public Health

The Ohio State University

Wednesday, October 21, 2009

12:00 pm-1:00 pm

240 Prior Health Sciences Library (CCTS Collaboratory)

Center for Clinical and Translational Science

376 W. 10th Ave, Suite 205

Very often in randomized clinical trials multiple outcomes (endpoints) are compared across groups. To draw conclusions about endpoints requires strong control of false positive (Type I) errors. Controlling these errors means increased loss of power (increased Type II error) as the number of endpoints increase. Hypothesis testing strategies are needed to control these errors, and this leads to detailed deliberations in choosing primary endpoints. Some principles in choosing primary and secondary endpoints are discussed by distinguishing their use in drawing conclusions from their use in making decisions, primarily about future research. Trial examples show how primary endpoints and hypothesis testing strategies were chosen to allow for strong conclusions and useful decisions.