Abstract:
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As we studied a number of less-well understood trials in a broad variety of indications, we especially observed the importance of good planning, communication and documentation. Part of good planning involves carefully tailored simulations to include even less likely scenarios; several of the studies that we looked at had final outcomes not anticipated during simulation. Both the DMC Charter and the SAP must be final and signed before the first interim analysis. It is recommended that the DMC Charter, while being specific, allow for flexibility of the DMC to fully utilize members' implicit knowledge as they study the efficacy and safety information presented and the DMC should have a designated sponsor contact with whom to confer in the event of unanticipated findings. We also saw the importance of good communication with the regulatory authority from first contact forward, continuing an open dialog as the study progresses.
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