Wednesday, 27 February 2013

Adaptive Designs for Clinical Trials

Mr. Peter Bruce is President of The Institute for Statistics Education at, if you flip a coin hundreds of times, there are sure to be points at which the proportion of heads or tails seems high. It is this phenomenon that makes it tricky to stop a clinical trial part way through, and claim success with statistical validity. The statistical design protocol must allow for flexible endpoints, and this flexibility must be paid for with more stringent alpha levels. Flexible (adaptive) designs are increasingly popular - learn more with Vidyadhar Phadke in his online course, "Adaptive Designs for Clinical Trials," at For more details please visit at

Classic statistical study designs have static features (sample size, allocation scheme, etc.) that don't let you take advantage of new information that comes in during a clinical trial. Adaptive designs let you modify the characteristics of ongoing trials based on interim results in the study. Adaptive designs increase the probability of success, reduce costs and the time to market, and promote accurate drug delivery to patients. However, they must be done properly to preserve statistical validity.

"Adaptive Designs for Clinical Trials" will introduce the adaptive design theory and the hands-on techniques for planning, designing, monitoring, and analyzing adaptive trials. It covers sample-size re-estimation, drop-loser, biomarker-adaptive design, and response-adaptive randomization designs.

Who Should Take This Course:
Statisticians with responsibility for designing, analyzing and reporting clinical trials.

Course Program:

Course outline: The course is structured as follows
  • General Concept
  • Fundamental Theory
  • Group Sequential Design
  • Adaptive Interim Analysis in Clinical Trials

  • Adaptive Dose Finding Design
  • Enrichment Design for Target Clinical Trials

  • Two-Stage Adaptive Design
  • Sample size estimation/allocation

  • Protocol Amendments
  • Clinical Trial Simulation
  • Efficiency of Adaptive Design
  • Case Studies

Dr. Vidyadhar Phadke, instructor, is a Senior Statistician with Cytel, Inc. the leading provider of clinical trial design services and a pioneer in the area of adaptive design.

Participants can ask questions and exchange comments with Dr. Phadke via a private discussion board throughout the period. The course takes place online at in a series of 4 weekly lessons and assignments, and requires about 15 hours/week. Participate at your own convenience; there are no set times when you are required to be online.

For Indian participants accepts registration for its courses at special prices in Indian Rupees through its partner, the Center for eLearning and Training (C-eLT), Pune.

For India Registration and pricing, please visit us at

Call: 020 66009116


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