Innovation in Clinical Research: The I-SPY Trial
Dr. Laura Esserman, breast cancer surgeon from the University of California at San Francisco, was a keynote speaker at this year’s CDISC International Interchange. Dr. Esserman started the presentation with an overview of the I-SPY2 clinical trial. According to Dr. Rebecca Kush, it could be the “most innovative trial in the world.” This trial makes use of biomarkers, an adaptive design, and tests multiple drugs simultaneously. It is a ‘standing trial’ with the opportunity to graduate drugs to the next stage, drop them or add new ones.
It currently takes 10-15 years for a new oncology drug to reach patients and costs around two billion dollars. Furthermore, less than 5% of eligible adults participate in clinical trials. There are “problems in the way we design trials” and the “current path is unsustainable” said Dr. Esserman. Problems with the current system include over-treating patients and not finding tumors in time to treat them effectively; and, traditionally, one drug is tested per trial. In contrast, the I-SPY2 trial tests up to 12 different investigational drugs simultaneously. Furthermore, the neoadjuvant approach used in this trial involves giving patients chemotherapy prior to surgery and then operating after the team has evaluated the tumor response, thus salvaging the biomarker initially. Drugs that are not effective in shrinking the tumor are replaced with new drugs; and drugs that prove effective are graduated to the next phase.
Additional innovations are planned for subsequent I-SPY trials. I-SPY3 aims to build upon the I-SPY2 design by adding eSource checklists in an electronic health record, to aggregate information for the clinician, and reducing the number of data points that are collected to those that are necessary. Dr. Esserman stated “efficient capture of mission critical data in an effective way is still missing in clinical research.” Collecting only what is necessary will help compress trial timelines as well as reduce their costs and ease the burden on the research clinician. Hopefully, these innovations will serve as examples for others striving to improve trial designs and processes.
Alana St. Clair, CDISC Associate Project Manager
Strength through Collaboration
Page 1 |
Page 2 |
Page 3 |
Page 4 |
Page 5 |
Page 6 |
Page 7 |
Page 8 |
Page 9 |
Page 10 |
Page 11 |
Page 12 |
Page 13 |
Page 14 |
Page 15 |
Page 16 |
Page 17 |
Page 18 |
Page 19 |
Page 20 |
Page 21 |
Page 22 |
Page 23 |
Page 24 |
Page 25 |
Page 26 |
Page 27 |
Page 28 |
Page 29 |
Page 30 |
Page 31 |
Page 32 |
Page 33 |
Page 34 |
Page 35 |
Page 36 |
Page 37 |
Page 38 |
Page 39 |
Page 40 |
Page 41 |
Page 42 |
Page 43 |
Page 44