The more complex a trial in terms of the number of investigational products, treatment arms and interventions involved in a study, the more there is a need for proper oversight of the study.
In large multicentre studies, it is not uncommon for the sponsor to ask an independent group of experts to review and give their opinion and approval on the conduct of the study. This is known as a steering committee. Their main responsibilities includes the design, safety and quality monitoring: they take responsibility for the scientific integrity of the research by reviewing the scientific validity of the study protocol, and assessing the study quality. They also monitor the progress of the study to maximise the chances of completing the study within the agreed time scale and allocated budget.
As with the DSMB, members of the steering committee should be independent - free of any financial, personal and professional bias.
In some cases, the sponsor may delegate the steering committee to be directly involved with communications with the DSMB on “open” session discussions and the DSMB recommendations following each review.
The steering committee can sometimes take on the role of the Protocol Review committee, as their role can be all encompassing.
References and further reading
MRC - TRIALS STEERING COMMITTEE (TSC
http://www.eme.ac.uk/investigators/pdfs/TSCGuidelines.pdf
Guidance for Clinical Trial Sponsors Establishment and Operation of Clinical Trial Data Monitoring Committees
http://www.fda.gov/downloads/RegulatoryInformation/Guidances/ucm127073.pdf
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