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Abstract:
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In our experience producing interim clinical trial reports for data monitoring committee (DMC) review, many trials are now being performed as multiple-protocol programs, which often consist of smaller and shorter studies than the larger and longer studies of the past. Reasons for this may vary, but in all cases it remains critical that DMCs are able to effectively and efficiently review accruing data to ensure the safety of all patients in the trials. We will explore issues that increase the complexity of monitoring such programs, including: reviewing multiple trials, possibly in different patient populations; pooling of data from similar protocols; trials beginning and ending at different times; and different numbers or dose levels of treatment groups. The University of Wisconsin–Madison Statistical Data Analysis Center (SDAC) supports DMCs in many disease areas by acting as an independent analysis group producing graphics-intensive interim reports. We discuss some of our best practices for multiple-protocol studies, including data management, programming techniques, and data presentation. In addition, we consider several approaches to organizing results for these programs.
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