A failure to determine the appropriate dose of a drug for clinical use is the leading cause of FDA non-approvals. Thus, the FDA and EMA have been becoming more and more supportive of Adaptive Design in clinical trials. It has now become a recommended strategy for conducting dose ranging trials.
Sponsors get advantage of the decreased cost and improved chances of the positive outcome of a study, while the patient safety also improves. Adaptive Design allows for more flexibility, which, in turn, helps avoid repeated clinical trials. Not only is it extremely cost-effective, but also much less time-consuming. So the investigated drug can potentially be brought to the market faster. It is both beneficial for patients, and can increase return on investments. Moreover, Adaptive Design improves risk management. It makes it possible to indicate failure on earlier stages due to interim data analyses. Furthermore, it offers an even more significant advantage — improved patient safety. Due to the reasons mentioned above, fewer patients in Adaptive Design clinical trials are assigned unsafe or/and ineffective doses of the drug. All of these aspects lead to the Adaptive Design gaining popularity.
Adoptive Design is a strategy that can make a clinical trial go smoother and faster. However, the sponsor and the CRO must design detailed SOPs and specific work practices carefully in order to be able to perform it. Data driven monitoring and integrated IT platform and software must also be implemented. While it can come with its own challenges, Adaptive Design in clinical trials proves to be effective in many cases and speeds up drug development.