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Understanding Cancer Series
Dr. James Doroshow, Director, Division of Cancer Treatment and Diagnosis. Credit: NCI, Ernie Branson; Photographer
At the opening presidential session of the 2010 annual meeting of the American Society of Clinical Oncology in Chicago, NCI Director John E. Niederhuber, M .D., gave an introduction to James H. Doroshow, M.D., director of NCI’s Division of Cancer Treatment and Diagnosis. It was Dr. Niederhuber’s task to present the multiple achievements that Dr. Doroshow has brought to advancing clinical trial reform and development at NCI.
“Jim understands clearly that a future in which we administer multiple targeted agents against optimally characterized tumors will require new thinking about private sector collaboration and the rights of intellectual property,” said Niederhuber. “He was instrumental in an effort to develop standard contract clauses that can be used to speed the opening of both investigator- and company-sponsored clinical trials.”
Dr. Niederhuber noted that Dr. Doroshow has been a key player in devoting resources necessary to bringing new drugs forward to first-in-human testing, with the example of Phase Zero trials as being a key advance. After bestowing the compliment of ‘ultimate public servant’ on him, Dr. Niederhuber left the stage to Dr. Doroshow, who went on to discuss how NCI asked for the Institute of Medicine review of the clinical trials processes and how NCI readily accepted their findings and is working, and has been working, on ways to advance and reform the clinical trials process.
One key element that Dr. Doroshow honed in on during his talk was the time for design and then accrual to trials, which now runs a median of 80 months. He made it known that that timeframe was no longer acceptable and that any phase 3 trial that wasn’t able to meet accrual deadlines within two years would be discontinued.
It was clear from Dr. Niederhuber’s introduction and Dr. Doroshow’s detailed presentation that the design and conduct of clinical trials has entered a new era.