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The Lowdown on Adaptive Clinical Trials with Don Berry

Guest:

Don Berry, Prof of Statistics, MD Anderson Cancer Center
Bio and Contact Info

Listen (5:39) What is the goal of I-SPY trials?

Listen (8:31) Why were adaptive trials not introduced sooner?

Listen (4:34) What is the latest from I-SPY 2?

Listen (3:06) What about other cancers and diseases?

Listen (3:51) We have barely scratched the surface with biomarkers

Listen (2:34) Thoughts on genetic testing space

Listen (2:35) Trials of one?

The development of therapeutic drugs is a lengthy and costly process and too often ends in failure during clinical trials. So, understandably, there is much interest in improving clinical trial design to take into account the individual biology of trial participants. This more precise approach not only has great potential to improve the chance for the therapy to succeed, it provides better outcomes for patients in the trial.

The I-SPY trials are just such an approach. These national studies are designed to identify biomarkers predictive of response to various therapies throughout the treatment cycle for women with breast cancer. These trials are being called adaptive because there are changes in design throughout the trial based on an examination of accumulated data at various interim points in the trial. A patient may start with one therapy, but end up in the same trial with another therapy.

Don Berry is the founding head of the division for Quantitative Biosciences at MD Anderson Cancer Center. He is one of the principal designers of the I-SPY trials.

Are there trials in progress for cancers other than breast cancer? Will adaptive trials be broadly adopted? How can we develop better biomarkers?

Join us today in learning about this promising new approach to clinical trials directly from one of the principal architects.

Podcast brought to you by: National Biomarker Development Alliance - Collaboratively creating standards for end-to-end systems-based biomarker development—to advance precision medicine