Cytel Strategist Discusses Clinical Trial Design and When to Include Interim Looks

Interim looks allow for sponsors of clinical trials to consider whether the trial should continue or if any modifications need to be examined. Knowing when it’s appropriate to incorporate an interim look can be a challenging yet necessary component of study design.

“A number of Cytel statisticians now approach trial design with the view that it is vital to begin by mapping and exploring the entire design space of a clinical trial. Sometimes this means running millions of simulations, and creating a heat map of all potential designs. One of our consultants recently mapped the potential costs and benefits of interim looks from 10% enrollment to 90% enrollment, for a client who could then zero in on the perfect time to view evidence.” Read more here.

(Source: Esha Senchaudhuri, Cytel, 8/9/21)