Adaptive Designs for Clinical Trials

Adaptive Designs for Clinical Trials

taught by Vidyadhar Phadke

Aim of Course:

This online course, "Adaptive Designs for Clinical Trials" will introduce the adaptive design theory and the hands-on techniques for planning, designing, monitoring, and analyzing adaptive trials. We will summarize the major statistical methods for adaptive trials with an emphasis on the relationships among them. You will learn different adaptive trial designs such as sample-size re-estimation, drop-loser, biomarker-adaptive design, and response-adaptive randomization designs through trial examples and the programming tools provided (SAS and R). Challenges of adaptive trial implementations will be discussed and recommendations are provided. Ultimately, the attendees are expected to walk away with the right knowledge, skill, and tools for designing and managing adaptive trials.

This course may be taken individually (one-off) or as part of a certificate program.
Course Program:

SESSION 1:

  • General Concept
  • Fundamental Theory
  • Group Sequential Design
  • Adaptive Interim Analysis in Clinical Trials

SESSION 2:

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

SESSION 3:

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

SESSION 4:

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

HOMEWORK:

Homework in this course consists of short answer questions to test concepts, guided data analysis problems using software, and guided data modeling problems using software.

In addition to assigned readings, this course also has discussion tasks, an end of course data modeling prject, example sofware examples/codes, and supplemental readings available online.

Adaptive Designs for Clinical Trials

Who Should Take This Course:
Statisticians with responsibility for designing, analyzing and reporting clinical trials.
Level:
Intermediate/Advanced
Organization of the Course:

This course has supplemental reading that are available online, software examples, an end of course data modeling project, and discussion based tasks.

Options for Credit and Recognition:

Course Text:

The following texts will be used during the course:

Pong, A.P. and Chow, S.C. (2010). Handbook of Adaptive Designs in Pharmaceutical and Clinical Development. Chapman and Hall/CRC, Taylor & Franics, New York, New York. 

FDA Draft Guidance on Adaptive Design Clinical Trials for Drugs and Biologics, The U.S. Food and Drug Administration, Rockville, Maryland, February, 2010, which can be downloaded here.

Software:

Students will have access to EaSt software, which implements some of statistical methods for the adaptive clinical trial designs described in the text book.  Illustrations and demos will be provided for students to work through on their own.

Instructor(s):

Dates:

March 06, 2020 to April 03, 2020

Adaptive Designs for Clinical Trials

Instructor(s):

Dates:
March 06, 2020 to April 03, 2020

Course Fee: $589

Do you meet course prerequisites? What about book & software? (Click here to learn more)

We have flexible policies to transfer to another course, or withdraw if necessary (modest fee applies)

Group rates: Click here to get information on group rates. 

First time student or academic? Click here for an introductory offer on select courses. Academic affiliation?  You may be eligible for a discount at checkout.

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