Data Monitoring Committees
Regulatory requirements can be imposed on clinical trials to assemble an independent group of experts to oversee the trial outside the sponosor organisation. Data Monitoring Committees (DMC) consists of a group of independent experts external to a clinical trial appointed by the sponsor. The DMC is responsible for independently safeguarding the interests of trial participants and assessment of safety data and efficacy endpoints as defined in the study’s DMC charter. Based on the DMC’s review of data they will provide a recommendation to the sponsor regarding study modification, continuation or termination. Based on the DMC recommendation the sponsor makes the final decision on next steps.
CTC can assist in many different aspects if a DMC is needed. This can be guidiance in regulatory aspects, arrangement of administrative tasks (i.e. preparing documents, scheduling and leading meetings), presenting of data at the meetings, providing medical advice and assistance in identifying suitable members.