DISCUSSION TOPIC #8 Should trials be continued if: The results for the primary endpoint are definitive, but there is uncertainty about key secondary outcomes ? Group 8. Interim Analysis.
DISCUSSION TOPIC #8Should trials be continued if: The results for the primary endpoint are definitive, but there is uncertainty about key secondary outcomes?Group 8
An evaluation of the current data from an ongoing trial, which can potentially modify the conduct of the study
Reasons to conduct interim analysis: Assess safety, identify important clinical findings, economic reasons
Data Monitoring Committee (DMC): multi-disciplinary committee that meets at pre-specified intervals to carefully weigh the risks and benefits of treatment effects and determine if early termination is practical
Early termination relies on meeting either one or a combination of these endpoints:
Primary Endpoint – A clinical endpoint that provides sufficient evidence to fully characterize the effect of treatment.
Ex: Disease-related death
Secondary Endpoint – A clinical endpoint that is of interest, but not primary interest. It can assess safety or help interpret a primary endpoint.
Ex: MI, stroke