Introduction to Adaptive Design for Clinical Trials

This 2-day seminar includes an overview of Adaptive Design, and an emphasis in group sequential design, sample size re-estimation, and Phase II/III Adaptive Seamless Designs.

The role of statistics in clinical trials incorporates the tools used to develop a robust study, minimize bias, and assess efficacy of new treatments as relates to comparison to competing therapies.

Randomized clinical trials remain the standard for clinical research. However, the cost of a traditional randomized controlled trial especially in large sample sizes and long study duration, are limiting factors of innovation in the pharmaceutical and medical device arenas. A trial with an adaptive design can often result in lower costs and more efficiency by making use of interim analyses with data accumulated during the course of a trial to modify a study, without compromising validity and integrity. Adaptive designs also allow for checking trial assumptions and progress before the conclusion of the study. Studies can be adapted for dose response, patient accrual, and early stopping for futility or patient safety concerns.

Areas Covered in the Session:
Overview of Applications for Adaptive Design in Clinical Trials
Statistical Techniques of Adaptive Design
Practical Considerations for implementation of an Adaptive Design
Regulatory Aspects of an Adaptive Design
When an Adaptive Design is, and is not, Appropriate
Examples of Clinical Trials that Incorporated Adaptive Design
Computer Code in R Statistical Software for Simulation Studies
Who will benefit:
Trial Sponsors
Principal Investigators
Clinical Investigators
Clinical Research Statisticians
Clinical Research Coordinators
Clinical Research Nurse Coordinators
Clinical Research Associates/Assistants
Clinical Project Managers/Leaders

Read More

View Less