What information should a sponsor of a randomized trial receive during its conduct?

Abstract

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.

Purpose: 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.