$0 – $150

Short Course: Design and Monitoring of Adaptive Clinical Trials: A Practica...

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Takeda Pharmaceuticals

35 Landsdowne Street

Cambridge, MA

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(Thanks to the generosity of Cytel Corporation, all proceeds will benefit the Boston Chapter of the American Statistical Association)

When designing a clinical trial, it is important to investigate many different combinations of design parameters - including power, spending functions, timing of interim analyses, and enrollment rates - to discover the most efficient combination for the trial under consideration. This workshop will include hands-on training for East, the industry standard clinical trial design software tool. Attendees will learn how to design, monitor and simulate fixed, group sequential and adaptive trials with one arm, two or multiple arms, for binary, continuous or time-to-event endpoints. We will review other new features, including:

  • extending available simulations through external calls to R functions

  • computation of Bayesian power or probability of success (assurance)

  • forecasting of enrollments and events

Pre-requisites: Attendees are expected to have basic knowledge of clinical trials, and a keen interest in adaptive designs.

Software: Attendees are expected to have East 6.4 installed on their computers before the seminar day. The Cytel Support Team and the event organizers will coordinate this effort, providing installation setup and the instructions to install the software well in advance of the seminar day.

Note: Web meeting links and conference dial-in information will be sent via email prior to May 5th.

Instructor Bios

Cyrus Mehta

Cyrus Mehta is President and co-founder of Cytel Corporation and Adjunct Professor of Biostatistics, Harvard University. Cytel (www.cytel.com) is a leading provider of software, clinical services and strategic consulting on the design, interim monitoring and implementation of adaptive clinical trials, with offices in the United States, Europe and India. 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, LogXact and East software packages that are widely used by the biopharmaceutical industry, academic research centers and regulatory agencies. He has over 100 publications in leading statistics and medical journals. He is a past co-winner of the George W. Snedecor Award from the American Statistical Association, 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. He has received the Lifetime Achievement Award from the International Indian Statistical Association (2015) and the Distinguished Alumi Award from the Indian Institute of Technology, Bombay (2016).

Charles Liu

Charles Liu has been a statistician and product manager at Cytel for over 5 years. He has a research background in Psychology, Neuroscience, and Biostatistics. Charles earned a PhD in Psychology from the University of Melbourne, Australia.

Hrishikesh Kulkarni

Hrishikesh Kulkarni has been a statistician at Cytel for over 9 years. He earned his Masters Degree in Statistics from Department of Statistics, University of Pune, India. Since then, he is involved in products like East and other Cytel products.

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Takeda Pharmaceuticals

35 Landsdowne Street

Cambridge, MA

View Map

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