By Parloop A Bhatt

Traditional clinical trials, in which a protocol is designed according to certain assumptions and strictly followed throughout the study, have numerous inefficiencies. Because there is no opportunity for researchers to adapt a protocol to reflect their increasing understanding of a drug as a trial progresses, the outcome may be inconclusive if the initial assumptions prove incorrect. The concept of reinventing the phases of clinical trials by certain adaptations made to the trial and/or statistical procedures of on-going clinical trials based on accrued data have been in practice for years in clinical research and development, thereby revolutionizing the way clinical research is being conducted. The potential benefits of adaptive trials are exciting, greatly enhancing the drug development process by requiring fewer patients and a reduced time to meet study endpoints. However, adaptive trials are challenging to implement. They must be designed carefully before they begin, with full scenario planning (including stoppage rules, decision trees and other important details) agreed beforehand with regulatory authorities. The purpose of this short review is to provide a comprehensive and unified presentation of the principles and methodologies in adaptive design and analysis with respect to adaptations made to the trial along with a well-balanced summary of current regulatory perspectives…read more

This entry was posted in News & Events.