Shaking Up Cancer Clinical Trials: An Interview With John Mendelsohn, M.D.

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A recent report from the Institute of Medicine (IOM) said the National Cancer Institute’s cooperative group program is not prepared to meet current opportunities in cancer research despite its contributions to past progress. The IOM criticized the program for being slow, bureaucratic, inefficient, and unproductive. Simultaneously, the American Society of Clinical Oncology (ASCO) published a survey showing that oncologists are planning to limit, or are considering limiting, their participation in trials because NCI’s reimbursement is inadequate. Although they were issued in April, the two reports continue to reverberate throughout the cancer community. John Mendelsohn, M.D. , president of the M. D. Anderson Cancer Center in Houston and chair of the IOM panel, spoke about the recommendations in press briefi ngs and oral sessions at the annual meetings of ASCO and the American Association for Cancer Research. Outgoing NCI director John Niederhuber, M.D., who commissioned the report, went further. He recommended to the National Cancer Advisory Board in June that the cooperative group system be scrapped and replaced by a system based on the NCI-funded cancer centers. Richard Schilsky, M.D., a longtime leader in the cooperative group system and an IOM panelist, responded publicly that this was not a good idea and that all the IOM recommendations should be implemented soon. Cooperative groups continued to be in the oncology news with an announcement that three of the groups would merge some administrative functions — a development in line with IOM recommendations but predating the report, they said. And incoming NCI director Harold Varmus, M.D., in his fi rst town hall meeting with staff, named the clinical trials system as one of several areas that were “obviously dysfunctional” and needed repair. Meanwhile, innovative trial designs, based on patient biomarkers, are attracting attention as ways to streamline and speed up trials ( see accompanying news stories). I interviewed Mendelsohn in May about the IOM report — A National Cancer Clinical Trials System for the 21st Century: Reinvigorating the NCI Cooperative Group Program — and what he thinks needs to be done to improve the cancer clinical trial system. JN: The IOM report was issued at the same time as the ASCO survey. With a new director scheduled to be appointed, was the timing a coincidence? JM: The IOM report was commissioned a year ago by NCI director Dr. John E. Niederhuber, over concerns about the program’s ability to maintain the progress they have produced. I hope that when the new director addresses the report, he will see it as helpful and accept our recommendations. It may allow the new head of the NCI to get cracking and not waste time with another review. [ Editor’s note: the interview occurred before a new director was named. ] JN: Your report found that the NCI’s review process delays launching a clinical trial. The NCI reports that 56% of phase III clinical trials took more than 2 years to start. How can the speed and effi ciency of the design, launch, and conduct of clinical trials be improved? JM: The entire process must be streamlined so we can implement ways to do it more effi ciently. The NCI has redundant review procedures that add to reviews by the cooperative groups, the intergroup scientifi c review committee, the Food and Drug Administration [FDA], etc. As modifi cations are made, protocols must be recycled again and again. All of this only serves to delay the launch of a clinical trial. The prime task should be to get an innovative, high-priority trial approved in a shorter period of time with adequate reimbursement for time and effort, adopting best practices for effi cacy and safety. Right now, the NCI, the FDA, the cooperative groups, pharmaceutical and biotech companies, and academic and community medical groups are looking at the shared goal of developing new drugs against cancer through different lenses with different agendas. If we could get all of the various people who have an interest in clinical trials and lock them in a room, we’d get lots of work done quickly and have a better trial. We are all going to have to do some giving because there is such a great opportunity today to exploit our capacity to select new drugs and antibodies that target the genetic abnormalities expressed in an individual patient’s cancer.