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Dissemination of trial results to participants in phase III pragmatic clinical trials: an audit of trial investigators intentions
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  • Published on: 11 May 2020
    The Black Box Called Clinical Trial Results
    • Satish C. Nair, Sr Specialist and Director Clinical Research Tawam Hospital Johns Hopkins Medicine, College of Medicine, UAE Univeristy, Al Ain, UAE

    The authors Raza et. al., address an important set back inherent to the clinical trial enterprise. Despite the high intention to disseminate results to trial participants by trial investigators, there is a systemic lack in the feedback methods and regulatory will by the ethics committees. The research ethics committee oversees the fact that the majority of the end of study reports ignore the mention of the dissemination of trial results to participants. The ICH-GCP guidelines emphasize little or none about trial result dissemination. Among the many gaps, the foremost among them is the end of the study report, submitted to the ethics committee after six months of study completion, is in a prescribed form. The form lacks the data fields to insist on the investigators to disseminate trial results to the participants. Participant data box (PDB) to mandate disclosure of trial results should be spread throughout the clinical trial process like blood capillaries in the body, tracking the trial’s performance on matters major and minuscule. There are reasons for this requirement, irrespective of whether a trial was successful or not. Firstly, the participants have the right to know the trial outcome. Secondly, the local community should know about the trials being conducted, to enhance public trust, Thirdly, the disclosure helps international participants and research community to calibrate their decisions. Similar to an airline's black box, the participant data box may revea...

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    Conflict of Interest:
    None declared.
  • Published on: 6 May 2020
    Clinical Trial Results: Time To Revisit ICH-GCP Guidelines
    • Satish C Nair, Senior Specialist and Director Medical Research Johns Hopkins Medicine, Tawam Hospital, College of Medicine, UAE

    Interestingly, Raza et. al., address an important issue related to the clinical trial enterprise. Despite the high intention to disseminate results to trial participants by trial investigators, there is a systemic lack in the feedback methods and regulatory framework. It is worthwhile to revisit the ICH-GCP guidelines and mandate trial result dissemination. Clinical trial participant data box (PDB) should be made mandatory for timely disclosure of trial results to participants and should be spread throughout the clinical trial process, tracking the trial’s performance on matters major and minuscule. There are reasons for this requirement: Firstly, the participants have the right to know the trial outcome. Secondly, the local community should know about the trials being conducted, to enhance public trust, Thirdly, the disclosure helps international participants and research community to calibrate their decisions. Similar to an airline's black box, the participant data box may reveal everything about the trial, or point the way and, rarely will they offer no clue at all. Additionally, the participant data box may also help trial investigators, sponsors, and participants to assess and learn from mistakes.

    Conflict of Interest:
    None declared.