What information should a sponsor of a randomized trial receive during its conduct?
BACKGROUND
The relationship and roles among the steering committee, the Data Safety Monitoring Board (DSMB), and the sponsor of a randomized clinical trial (RCT) must be carefully defined to ensure the integrity of the trial.


OBJECTIVE
We present an unusual scenario that arose during the conduct of a large RCT in Canada that involved the relationship of the steering committee and the DSMB with the peer review sponsor.


METHODS
Case study of a large RCT conducted in Canada and a commentary on the roles and responsibilities of the steering committee, DSMB, and sponsor.


CONCLUSIONS
This case illustrates the need for funding agencies to understand the importance of respecting the independence of the DSMB and the need to keep confidential emerging trends regarding study results, including the conditional probability, during the conduct of a trial.
Department of Medicine and Epidemiology, McMaster University, Hamilton, Ontario, Canada. anands@mcmaster.ca
Sonia S
SS
Anand
Janet
J
Wittes
Salim
S
Yusuf
D026683:Advisory Committees; D002170:Canada; D026661:Clinical Trials Data Monitoring Committees; D030881:Disclosure; D016032:Randomized Controlled Trials as Topic / Q000191:economics / Q000941:ethics*; D017751:Safety Management