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The CTC is a world leader in the independent monitoring of clinical trials for safety. We help to establish and serve on Independent Data Safety and Monitoring Committees (IDSMC) in Australia and internationally, for both investigator-initiated and commercially-sponsored trials.
IDSCMs independently review information arising from a trial while it is operating to ensure scientific, regulatory and ethical standards are being adhered to. In this trial oversight role, IDSCMs make recommendations to trial steering committees (TSC) around issues such as patient safety, emerging external evidence that could impact a trial, and the trial’s capacity to address the primary scientific question it is investigating.
The CTC also has expertise in developing terms of reference for IDSMCs, as well as providing advice to established IDSMCs on challenging problems, such as lower than expected event rates and high rates of patient cross-over to alternative treatments.