Ken Getz: Trends in Protocol Design Practice and Optimization
The scientific and operating demands of protocol designs have increased rapidly during the past decade due to numerous factors. This talk characterizes trends in, and the forces driving, protocol design practices. The impact of these practices on clinical trial performance and economics will be addressed. Several protocol design optimization strategies will also be discussed including the adoption and use of adaptive designs and patient centric approaches.
Joe Massaro: Designing and Operating a High Performance DMC/DSMB - Controlling Possible Bias
In an adaptive clinical trial, a Data Monitoring Committee (DMC), also known as a Data Safety Monitoring Board (DSMB), may review interim efficacy data at planned intervals to determine if the trial should be adapted, such as stopping the trial early or increasing the sample size for the final analysis. Here we will discuss examples of the types of interim study results commonly provided to DMC/DSMBs; how and to whom communication of study results should be disseminated by the DMC/DSMB after their review of interim data; and the potential for biasing the remainder of the study, whether adapted or not, if such communications are not handled appropriately.
Dale Usner: Adaptive Design Practical Considerations and Execution
Adaptive designs, statistical backbone, team effort. Multiple illustrative examples will be used to present the practical considerations and execution of designing and running various adaptive design strategies, including logistics and impact on clinical operations, data management, and randomization services with focus on implications for statisticians.