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Medicine LibreTexts

7: Trial governance

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    • 7.1: Introduction to trial governance
      Since the first edition of this book was published in 1991, there has been a very large increase in the number of field trials of health interventions being conducted in LMICs and, in parallel with this expansion, an increasing number of regulations and guidelines put in place to govern the conduct of clinical trials.
    • 7.2: The trial sponsor
      Whenever a field or clinical trial is conducted that involves human participants, it is necessary that an individual, or more commonly an institution, has legal responsibility for the trial, ensures that the trial is conducted properly, according to a defined protocol, and has overall responsibility for the management and financing of the study. This person, or institution, is known as the sponsor of the trial.
    • 7.3: Steering committee
      It is common in large trials, particularly multicentre trials, for a steering committee to be set up, to which the PI reports and from which the PI may seek guidance or authorization, with respect to aspects of the conduct of the trial.
    • 7.4: Data and Safety Monitoring Board
      For trials of interventions that may entail the possibility of significant harm, as well as benefit, to participants, the trial sponsor should establish a DSMB—sometimes termed a committee (DSMC), a Data Monitoring Board (DMB) (or Committee (DMC)), or Independent Data Monitoring Committee (IDMC). The DSMB is independent of those conducting the trial and separate from the ethics review committee (ERC) to monitor the safety of the trial, while it is being conducted. Not all trials will require a D
    • 7.5: Trial registration
      Until relatively recently, there were no comprehensive sources of information about ongoing clinical trials. Not infrequently, trials would be started and would be prematurely ended with knowledge of their conduct known only to those closely associated with the trial if the findings were not published in the medical literature. Other trials were completed, but their results were never reported for various reasons, including that the investigators or sponsors did not like the findings of the tria
    • 7.6: References