Interview: Adaptive Clinical Trials

October 4 , 2007
Phil Banks
Interviewed as an 'Expert from the Field' in recent Adaption Adoption PharmaVoice article on Adaptive Clinical Trials

PharmaVoice:
How do you define adaptive trials and how are these designs put into practice?

Mr. Banks :
"The primary objective of an adaptive trial is to modify a study design based on interim looks at observed data with adequate control of the Type I error (i.e., probability of concluding that a treatment difference exists when, in fact, it does not). Modifications can be made for a variety number of design features and include: sample size re-estimation, changing the treatment arm allocation ratio, eliminate/add treatment arms, reformulation of the study hypothesis, and enrich subpopulations.

Adaptive trials can aid the drug development process by requiring fewer patients and/or a reduced time to meet study endpoints. However, these designs can result in complicated decisions and uncertainty about the best approach for data analysis. In planning an adaptive trial, one needs to preserve the operational characteristics of the design and maintain credibility. Consequently, these trials require extensive planning and should be a collaborative effort with the regulatory authorities."

- click here to read the entire article on Adaptive Clinical Trial design -

About Phillip L. Banks, MS, FRS:
Phil is Prologue's Senior Director of Biostatistics and Information Technology. In addition to his extensive expertise in statistical analysis methods, Phil has a wealth of knowledge about oncology trial protocol design and is at the forefront of the new adaptive design initiative. His input at the oncology protocol development phase is essential to creating an efficient and effective clinical trial.

Featured Presentations on Adaptive Clinical Trials:

Adaptive Designs for Clinical Trials - IIR USA's Oncology Clinical Trials conference, April 10-12, 2007; Orlando, FL
Self Design Trials - Trial Adjustment Strategies to Amplify Trial Results - IIR USA's Oncology Clinical Trials conference, April 5, 2006; Las Vegas, NV

For more information about Phil, click here to read his bio.