The I-SPY 2 Breast Cancer Trial: How Clinical Trials May Be Changing

Three pill bottles spilling.It takes a very long time–thirteen years on average–for a new cancer drug to be developed, go through the standard clinical trials process and become available for patients.

Only a fraction of oncology drugs studied in clinical trials are successful. And the cost is extremely high at hundreds of millions of dollars to bring one new drug to patients. These facts, and the reasons behind this dysfunctional process, are discussed by Clifton Leaf in his book, “The Truth in Small Doses,” which I recently reviewed.

What can be done to bring better therapies to patients more quickly? One approach that is being tested is called “adaptive” clinical trial design.

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Review of “The Truth in Small Doses” by Clifton Leaf

In "The Truth in Small Doses," Clifton Leaf explains that the culture around cancer research has slowed progress.Last December, for the first time, I attended the San Antonio Breast Cancer Symposium as a patient advocate. Each year, thousands of oncologists and cancer researchers go to this event to hear about advances in breast cancer research and breaking results from important clinical trials.

I was excited to be attending, but was soon struck by the contrast between the enormous gains that are being made in understanding the biology of breast cancer, and the slow progress in translating these remarkable findings into clinical application. Reading Clifton Leaf’s book, “The Truth in Small Doses: Why We’re Losing the War on Cancer–and How to Win It,” has given me some food for thought as to why we may be facing this situation.

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