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Sunday, December 11, 2016

Novel Precision Medicine Trial Designs JAMA Oncology

Novel Precision Medicine Trial Designs | Oncology | JAMA Oncology | The JAMA Network


What Is Precision Medicine in Cancer, and Why Do We Need New Trial Designs?
Precision medicine in cancer care leads us to transition from a “one size fits all” approach of categorizing cancers by the body organ where they began (eg, breast, lung, colon) to a focus instead on specific identified mutations that may drive a cancer. One advantage of the old model of treating broad populations with the same approach was that it was possible to conduct studies that included many patients who, we thought, shared the same disease. With the greater resolution of precision medicine looking for particular mutations, we now must split those populations into much smaller subgroups. In some cases, these subgroups may be just a very small percentage of the overall population of patients with a given cancer, creating challenges in how to study the best treatments for them.
Two new and very different trial designs for molecular targets in cancer care are umbrella trials and basket trials......


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