Responses

Download PDFPDF

Dissemination of trial results to participants in phase III pragmatic clinical trials: an audit of trial investigators intentions
Compose Response

Plain text

  • No HTML tags allowed.
  • Web page addresses and e-mail addresses turn into links automatically.
  • Lines and paragraphs break automatically.
Author Information
First or given name, e.g. 'Peter'.
Your last, or family, name, e.g. 'MacMoody'.
Your email address, e.g. higgs-boson@gmail.com
Your role and/or occupation, e.g. 'Orthopedic Surgeon'.
Your organization or institution (if applicable), e.g. 'Royal Free Hospital'.
Statement of Competing Interests

PLEASE NOTE:

  • Responses are moderated before posting and publication is at the absolute discretion of BMJ, however they are not peer-reviewed
  • Once published, you will not have the right to remove or edit your response. Removal or editing of responses is at BMJ's absolute discretion
  • If patients could recognise themselves, or anyone else could recognise a patient from your description, please obtain the patient's written consent to publication and send them to the editorial office before submitting your response [Patient consent forms]
  • By submitting this response you are agreeing to our full [Response terms and requirements]

Vertical Tabs

Other responses

Jump to comment:

  • Published on:
    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.
  • Published on:
    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...

    Show More
    Conflict of Interest:
    None declared.