Designing Clinical Trials from a Program Perspective

In this webinar, Nitin Patel provides an overview of the concepts of program optimization. As a case study, he describes a phase II trial design based on program-level optimization. We utilize a hybrid Bayesian-frequentist framework to evaluate the impact of phase II design choices on the probability of phase III success, clinical utility, time to market, trial costs and expected net present value (ENPV) of the product. These factors include phase II sample size, go-no go and dose selection decision rules for phase III, and phase III sample size. Using neuropathic pain as an example, we use simulations to illustrate the framework and show the benefit of including these factors in the overall decision process.

Key Takeaways

• Understanding the value of designing clinical trials considering downstream consequences,
• Role of simulation in optimizing clinical trials' performance from a program perspective,
• Understanding the hybrid Bayesian-frequentist approach to clinical trial design

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Meet the Speaker

Over 30 years in the US, Nitin Patel has led development of several innovative statistical software products and worked on collaborative research projects with major pharmaceutical companies. He has served as a member of PhRMA and DIA working groups on adaptive trials contributing in the areas of dose finding trial design, drug supply, adaptive programs and portfolio optimization. In India he worked at Tata Consultancy Services where he was a member of the founding management team in 1966. He joined IIM Ahmedabad as professor in 1975.

He co-founded Cytel with Cyrus Mehta in 1987 where he is a member of the board and a lead researcher at the Innovation Center. He has Masters degrees in Management and in Computer Science-Electrical Engineering, and a Ph.D. in Operations Research from MIT. He has been a visiting professor at MIT and at Harvard University for over a decade. He is a Fellow of the American Statistical Association and a Fellow of the Computer Society of India. He has served as president of the Operational Research Society of India and as vice president of the International Federation of Operations Research Societies. He has published over 70 professional peer-reviewed papers and book chapters and co-authored a book on data mining that is now in its 3rd edition.