Design and Monitoring of Adaptive Clinical Trials

Course title

Faculty

Cyrus R. Mehta, Ph.D. Cytel Inc. and Harvard School of Public Health and Pantelis Vlachos, PhD. Cytel Inc.

Cyrus Mehta is President and co-founder of Cytel Inc. and Adjunct Professor of Biostatistics, Harvard University. Cytel is a leading provider of software and services for the design, interim monitoring and implementation of adaptive clinical trials. Dr. Mehta consults extensively with the biopharmaceutical industry on group sequential and adaptive design, offers workshops on these topics, and serves on data monitoring and steering committees for trials in many therapeutic areas including oncology, cardiology, neurology and metabolic disease. He has led the development of the StatXact®, LogXac®t and East® software packages that are widely used in the biopharmaceutical industry and at academic research centers. He publishes his methodological research in leading statistics journals and is a past co-winner of the George W. Snedecor Award from the American Statistical Association. He is a Fellow of the American Statistical Association and an elected member of the International Statistical Institute. He was named Mosteller Statistician of the Year by the Massachusetts Chapter of the American Statistical Association in 2000, and Outstanding Zoroastrian Entrepreneur by the World Zoroastrian Chamber of Commerce in 2002.

Pantelis Vlachos is Director of Strategic Consulting at Cytel. He is responsible for assisting pharmaceutical and biotech clients with the design of their clinical development programs and clinical trials, including adaptive designs of late stage trials and early stage dose-finding trials. He participates in designing, development, testing and refinement of Cytel's software products. Prior to Cytel, he was principal biostatistician at Merck-Serono where, among other activities, he developed and implemented standard analytical and graphical tools for reporting of safety data. Pantelis was also a Professor of Statistics at Carnegie Mellon University for 12 years. His research interests lie in the area of adaptive designs, mainly from a Bayesian perspective, as well as hierarchical model testing and checking although his secret passion is Text Mining. He is the Managing Editor of the journal “Bayesian Analysis” and has served in the editorial boards of several other journals and online statistical data and software archives.

Course language

English

Course schedule

June 22, 23, 25: 9:00am to 1:00pm
June 26: 9:00am to 12:00

Description

This short-course is designed for students who are interested in understanding the motivation, statistical methods and operational challenges associated with the design and implementation of adaptive clinical trials. Adaptive designs permit data dependent changes to an on-going clinical trial that can improve the probability of success without undermining the statistical validity of the final analysis. While the emphasis will be on statistical methodology we will also discuss regulatory and data monitoring considerations, case studies and important publications. Laboratory exercises with the East® software will be an integral part of the curriculum. Each student will be given a six-month license for unlimited use of the East® 6.3 software running on Microsoft Windows. By the end of the course the students will gain an understanding of the advantages and limitations of adaptive designs, be able to design such trials themselves, be proficient with the East® software, and be exposed to some actual case studies. The course will be especially valuable to students who are considering a career in the biopharmaceutical industry.

Evaluation

There will be homework exercises based on the class material and the computer labs. These will be graded.

Classrooom

PC2