All Times EDT
Keywords: interim analysis, Type I error
Interim analyses have been implemented nowadays to accelerate drug development and increase success rates in many clinical trials. Although valid group sequential procedures are available for trial planners to follow, it is not always straightforward for them to determine and utilize a proper procedure to control the overall study Type I error, and thereby ensure trial integrity. Numerous factors must be considered for studies that involve multiple endpoints, multiple doses, and significant trial adaptations, such as increasing sample size and dropping treatment arms according to interim analysis results. Many trial sponsors also are not clear about interim analysis planning for a seamless trial with a surrogate endpoint in the interim for accelerated approval versus a regular trial with an outcome endpoint in the final analysis for full approval. In my presentation, I will discuss pros and cons of adopting interim analysis planning in clinical trials, associated procedures, and other important considerations. I will illustrate a detailed plan for interim analysis from real case examples under different scenarios.