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Analysis of where things go wrong in clinical trials suggests that continuing oversight and monitoring are just as, if not more important than initial review.
I agree that Data Monitoring Committees (DMCs) are increasingly being recognised as a vital part of the oversight of clinical trials.
They have become a standard feature of academic trials, but not in the private sector.
Although it is common in the ethics review process to request information as to whether there is a DMC or not, committees or boards are currently powerless to compel the use of one. While they have the ability to deny approval in the absence of a DMC, many would consider this impractical at present, at least for industry trials.
The International Committee of Medical Journal Editors (ICMJE) has recently flexed its muscles and made clinical trial registry mandatory (1). It is now up to the ethics review community to fall into line and make sure that this step has been followed, since inability to publish must surely raise ethical concerns about a research proposal.
Perhaps the appropriate use of DMCs should also be an area scrutinised by ICMJE. An a priori request for a DMC by ICMJE would have a powerful educational message, and ethics review bodies could make ICMJE compliance part of the necessary prerequisites for approval.
DMCs: Time for ICMJE
Analysis of where things go wrong in clinical trials suggests that continuing oversight and monitoring are just as, if not more important than initial review.
I agree that Data Monitoring Committees (DMCs) are increasingly being recognised as a vital part of the oversight of clinical trials.
They have become a standard feature of academic trials, but not in the private sector.
Although it is common in the ethics review process to request information as to whether there is a DMC or not, committees or boards are currently powerless to compel the use of one. While they have the ability to deny approval in the absence of a DMC, many would consider this impractical at present, at least for industry trials.
The International Committee of Medical Journal Editors (ICMJE) has recently flexed its muscles and made clinical trial registry mandatory (1). It is now up to the ethics review community to fall into line and make sure that this step has been followed, since inability to publish must surely raise ethical concerns about a research proposal.
Perhaps the appropriate use of DMCs should also be an area scrutinised by ICMJE. An a priori request for a DMC by ICMJE would have a powerful educational message, and ethics review bodies could make ICMJE compliance part of the necessary prerequisites for approval.
References
1. http://www.icmje.org/clin_trial.pdf
Competing interests:
Member of and former chair of Research Ethics Board
Competing interests: No competing interests