PAREXEL - Increased Interest in Adaptive Design Trials - Dr Sy Pretorius Explains
Recently, there has been an increased interest in adaptive trial design. There are several reasons for this increased interest. For one, the regulatory agencies -- especially the FDA in the U.S. and EMA in Europe -- are emphasizing the use of adaptive trials. Both of these agencies have been very supportive in terms of their comments around the use of the adaptive designs where the designs are appropriate. Secondly, the pharmaceutical industry is facing major pipeline and financial challenges, and we are therefore searching for ways to reduce the cost and time associated with clinical trials - adaptive trials offer a possibility in this regard. Thirdly, there have been several recent advancements in the adaptive design and operational execution enablers - that is advancements in the development of the appropriate operational execution environment to run these trials, including statistical and information technology advances that support these trials. And then finally, there is a growing interest in personalized and targeted medicines and master protocols -- adaptive designs align very well with both of these two concepts.