IOM Committee Recommends Overhaul of NCI Clinical Trials Cooperative Group Program
A special Institute of Medicine (IOM) committee has recommended substantial restructuring and increased funding of NCI’s Clinical Trials Cooperative Group Program in a report issued April 15 titled A National Cancer Clinical Trials System for the 21st Century: Reinvigorating the NCI Cooperative Group Program.
The IOM committee’s report and analysis, which was requested by NCI Director Dr. John E. Niederhuber, lauded the cooperative groups’ substantial contributions in past years to landmark research for improving cancer care. However, Dr. John Mendelsohn, IOM committee chairman and president of the University of Texas M. D. Anderson Cancer Center, also cautioned that “the NCI Cooperative Group Program is falling short of its full potential to improve the quality of care that cancer patients receive. An accumulation of problems is hampering progress just at a time when new knowledge about the genetic and molecular underpinnings of cancer has created opportunities for designing trials with new, targeted anticancer agents.”
The IOM committee issued recommendations based on four broad goals for improving the cooperative group clinical trials process:
- Improve the efficiency and reduce average time for the design and launch of innovative clinical trials by consolidating functions, committees, and cooperative groups; streamlining oversight processes; facilitating collaboration; and streamlining and standardizing data collection and analysis.
- Incorporate innovation in science and trial design, for example, in studies identifying biomarkers that can predict therapeutic response.
- Adequately support those clinical trials that have the greatest possibility of improving survival and the quality of life for cancer patients, and increase the rate of clinical trial completion and publication.
- Incentivize the participation of patients and physicians in clinical trials by providing adequate funds to cover the costs of research by reimbursing the costs of standard patient care during the trial.
In an independent survey of NCI cooperative group members, conducted by the American Society of Clinical Oncology (ASCO) and published in the May issue of the Journal of Oncology Practice, 33 percent of respondents were planning to limit their participation in NCI-funded cooperative trials and another 9 percent were considering limiting participation. A majority (75 percent) of these cooperative group respondents cited inadequate NCI reimbursement as the reason for limiting involvement in such studies. NCI’s per-patient case reimbursement of $2,000 for cooperative group studies has not changed in 10 years and falls short of the estimated $5,000 to $6,000 typically spent per patient enrolled, the ASCO authors wrote.
Dr. Mendelsohn noted that the IOM committee also endorsed the recommendations recently made by NCI’s Operational Efficiency Working Group (OEWG), which aim to achieve similar goals for improving the cooperative group program and cancer clinical trials in general. Those recommendations were highlighted by Dr. James H. Doroshow, director of NCI’s Division of Cancer Treatment and Diagnosis in an April 6 Guest Director's Update for the NCI Cancer Bulletin.
Responding to the IOM report’s release, Dr. Doroshow expressed thanks to the IOM committee for their efforts and “complete endorsement” of the OEWG report. “We will carefully review the IOM report and equally carefully consider how we will follow up on its recommendations,” he added. “Our hope is that this report will complement NCI’s ongoing efforts to improve the clinical trials system, as we continue working to implement the recommendations of our Clinical Trials Working Group’s 2005 report.”
The IOM report helps “reinforce the notion that in an era of molecular oncology the clinical trials process must change,” Dr. Doroshow added. “The costs—in dollars and time—to bring a new drug to market are unsustainable. Moreover, cancer clinical trials of the future will require the testing of multiple agents against multiple disease targets. Creating a cancer clinical trials system capable of testing multiple hypotheses faster, with less cost and greater efficiency, is and must remain one of NCI’s highest priorities.”