Viewing posts categorised under: Adaptive-trials

Adaptive Trial Design in Clinical Trials Growing in Popularity

A recent industry and regulatory discussion has revealed an industry-wide adoption rate of about 20 percent for adaptive trials, with an expectation of significant growth over the next several years. One factor promoting the anticipated increase in adaptive trial acceptance is the receptiveness of FDA and EMA to exploratory phase adaptive trial design: Regulatory agencies […]

Adaptive Trial Design for Phase I, Phase II

Adaptive trial design is a hot issue in the drug development community. Adaptive conferences and web seminars abound, and suddenly, every consultant or vendor to the industry has become an adaptive expert. The FDA and EMEA are also much more receptive to adaptive trials than they were a few years ago. However, the picture is a shade different from what the industry had expected. Originally, much of the focus was on adaptive phase III trials as well as on seamless phase II/III trials. Those are, indeed, successfully being implemented today. But the real action is in phase II dose-finding trials and even in phase I trials for safety.

Transforming Oncology Drug Development with Adaptive Trials

Transforming Oncology Drug Development with Adaptive Trials - Complimentary Webinar Thursday, April 7th from 11-12pm EST Why should those engaged in oncology research be interested in adaptive trials? Over 50% of confirmatory studies today end in failure – an especially distressing reality for oncologists and developers of cancer treatments. But now, new adaptive study designs with a greater probability for successful outcome are helping reverse this discouraging trend.