ABSTRACT
Despite the tremendous progress and wide publicity of adaptive designs, many clinical trial planners avoid their prospective applications. There are a variety of reasons. The urban legend has always been that regulatory agencies discourage adaptive designs. In our observations of the pharmaceutical industry, we see two undocumented reasons. First and foremost, many trial planners are satisfied with the status quo of simple designs, which, in the eyes of many, represent a conservative approach. However, what is considered to be a “safe” approach often brings risks to patients, trial success, as well as financial sustainability of the sponsor. Ultimately, this leads to a high-attrition rate for drug development or deprives patients of the needed treatment early. The second reason is trial planners’ over confidence, or lacking knowledge of the various explicit or implicit assumptions made for the trial design. In reality, clinical trials do not always operate according to overly optimistic assumptions made, but rather they are negatively impacted by circumstances that are often beyond the control of trial planners.
