How to utilize an independent data monitoring committee to run an adaptive clinical trial?
*LJ Wei, Harvard School of Public Health
A typical data monitoring committee (DMC) for a clinical trial sponsored by the drug industry consists of clinicians and quantitative scientists, who are general from academic institutes and appointed by the sponsor. The committee members are reimbursed for their time spent on the DMC by the sponsor directly. These create obvious conflict of interest. If the DMC is assigned to a specific study, the members may not have access to the efficacy and safety information from similar studies conducted in the entire development program for the same compound. When there is an adaptive component in the trial, it is rather difficult to implement it by the DMC alone without much input from the sponsor during the study. Generally the sponsor would provide a list of scenarios for adaptation in advance as the guidance of DMC’s decision makings. These setups are not ideal. In this talk, we explore alternatives for conducting the data monitoring without losing the integrity of the study or much conflict of interest.
April 30 - May 22, 2013
Invited Abstract Submission Open
June 4, 2013
Online Registration Opens
August 9 - August 23, 2013
Invited Abstract Editing
August 23, 2013
Short Course materials due from Instructors
August 26, 2013
September 9, 2013
Cancellation Deadline and Registration Closes @ 11:59 pm EDT
September 16 - September 18, 2013
Marriott Wardman Park, Washington, DC