Adaptive Trial Design in Clinical Trials: What You Need to Know

In the quest to increase the efficiency and effectiveness of clinical trials, adaptive design methods have arisen, with support from the FDA. Adaptive trial designs use accumulating data to modify trials under progress without undermining the integrity of the trials. They allow sponsors to adjust certain parameters such as dosage, subject population, or sample size in consideration of statistically significant safety or efficacy data. The goals are to accelerate clinical development and improve its efficiency, better target experimental drugs to responsive patient groups, and reduce the number of patients exposed to inappropriate or ineffective therapies. According to recent studies that have addressed the topic, adaptive trials save three months in trial duration on average but may save up to a year in the trial process.

Dr. Greg Wei will address the components that go into the design, simulation and clinical execution services for adaptive trials. Attendees will learn how to reduce cycle times and late stage attrition rates while managing the ethical considerations that are at the heart of everything.

Dr. Wei’s co-presenter will be Zoran Antonijevic, Chair of the Adaptive Design Scientific Working Group with DIA and Senior Director, Strategic Consulting, with Cytel.

Speakers

Cheng Gang Greg Wei, Ph.D. , Research Fellow, SynteractHCR

An expert on biostatistics for regulatory issues, Dr. Greg Wei has more than 20 years of Pharmaceutical and statistical experience and leads the adaptive trial design team at SynteractHCR, a full service, international CRO. Wei has direct regulatory experience with the FDA and EMA, and has presented to both agencies on special protocol assessment and adaptive trial design, both of which are crucial areas for pharma and biotech companies as they are pressured to increase trial efficiency and reduce study costs. As a Research Fellow, Greg serves as an internal statistical consultant to other statisticians and programmers for implementing statistical methodologies and interpretation of outcomes of statistical analyses. He also serves as a subject matter expert and technical advisor on current and trending best practices.

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Zoran Antonijevic, Senior Director, Strategic Consulting, Cytel, Chair of the Adaptive Design Scientific Working Group at DIA

At Cytel, Zoran Antonijevic is responsible for strategic quantitative input at trial, program, or portfolio level design of adaptive trials, where he defines decision criteria and design parameters that optimize development programs/portfolios. He is a member of the data monitoring committee and represents clients at FDA meetings. As Chair of the Adaptive Design Scientific Working Group with DIA, Zoran has been a strong supporter for the development of processes and tools for the implementation of adaptive clinical trials.

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