Recorded June 13, 2017
Webinar On Demand
Trends in Protocol Design Practice and Optimization
Presented by: Ken Getz, Director of Sponsored Programs at the Center for the Study of Drug Development, Tufts University School of Medicine
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.
Designing and Operating a High Performance DMC/DSMB – Controlling Possible Bias
Presented by: Joe Massaro, Biostatistics Professor at Boston University School of Public Health
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.
Adaptive Design Practical Considerations and Execution
Presented by: Dale Usner, PhD, CSO & Sr. VP, Strategic Scientific Consulting at SDC
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.