Abstract
Surgeons designing and running their own clinical trials must not only be well-versed with clinical trial methodology but also with associated ethical and regulatory issues. A key consideration here is the data monitoring committee or the data safety and monitoring board (DSMB), which broadly oversees the trial. Made of a group of independent experts having subject matter knowledge, along with experts in ethics, biostatistics, clinical research, and multicentre trial experience, as appropriate, the DSMB ensures the safe and efficacious running of a trial. Its responsibilities include approval of the trial plan, regular review of the trial to ensure participant safety, quality of data collection and protocol compliance, and ensuring appropriate interim analyses are carried out. Based on the latter, the DSMB also regulates the need for early stoppage of the trial. While wide variation exists on how a DSMB should be run, academic surgeons need to be aware of core considerations of data monitoring and patient safety during a trial.
Published Version
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