Key Committees

Protocol Review Committee:

Protocol Review Committees have been set up by some sponsors to evaluate and approve clinical study protocols.

Steering Committee:

The Steering Committee oversees the overall conduct of the study and implements recommendations from the DSMB or other expert review committees as necessary. The committee’s membership consists of internationallly-recognized experts in a field of medicine relevant to the trial population and experienced in the conduct of clinical trials.

Data Monitoring Committee or Data Safety Monitoring Board:

DMC or DSMB are responsible for ensuring patient safety when the clinical trial involves mortality or morbidity outcomes or when the safety of a therapeutic intervention needs to be closely monitored.

The committe reviews unblinded safety data at regular intervals and can issue recommendations for continuation or termination of a treatment arm or the trial to the Steering Committee when clear evidence of benefit or harm becomes apparent.

Clinical Endpoint Committees:

Clinical Endpoint Committees review blinded clinical efficacy and safety endpoints to adjudicate (i.e., to categorize) events according to pre-specifed criteria.

This process ensures that the many biases that can influence reviewers (such as treatmenrt expectations, prior experiences, and cultural or regional differences in the practice of medicine) are minimized and thus major efficacy and safety endpoints are objectively assessed.