ASCO Survey Finds NCI Cooperative Groups Limiting Clinical Trial Participation

April 15, 2010

Amanda Stanley
(571) 483-1364

In this news digest:

  • Summary of a survey being published online on April 15, 2010 on the Journal of Oncology Practice (JOP) Web site, showing that National Cancer Institute Cooperative Group clinical trials per-case reimbursement negatively affects participation in federally funded clinical trials.
  • Link to ASCO statement on the Institute of Medicine (IOM) report, “A National Cancer Clinical Trials System for the 21st Century: Reinvigorating the NCI Cooperative Group Program”
  • Links to additional information for patients and practitioners on Cancer.Net

Note: Today, IOM will issue a new report, “A National Cancer Clinical Trials System for the 21st Century: Reinvigorating the NCI Cooperative Group Program,” which will provide comprehensive recommendations to strengthen the National Cancer Institute’s Clinical Trials Cooperative Group Program. The 10 Cooperative Groups conduct collaborative large-scale cancer clinical trials that currently enroll 25,000 participants annually. Cooperative Group trials have led to fundamental advances in cancer treatment, quality of life, and prevention, and have contributed to the significant reduction in death rates from cancer over the past 15 years.

This news digest summarizes a new ASCO survey suggesting that increased funding for the Cooperative Group Program is critical to its success.

A new survey conducted by the American Society of Clinical Oncology (ASCO) finds that one-third of National Cancer Institute (NCI) Cooperative Group Sites plan to limit participation in federally funded clinical trials due to inadequate per-case reimbursement. Additionally, nearly 40 percent of sites planning to limit NCI Cooperative Group trials reported plans to increase industry trial participation, despite expressing a preference for conducting Cooperative Group trials.

Federally funded Cooperative Group clinical trials often examine questions that the private sector has little incentive to investigate, such as the comparative effectiveness of treatments made by different companies, therapies for rare diseases, and quality of life after treatment.

“This study indicates that far too many NCI Cooperative Group sites plan to reduce participation in federally funded clinical trials,” said ASCO President and co-author Douglas W. Blayney, MD. “Clinical trials are the essential link between laboratory discoveries and new treatments for patients. The outcomes of clinical trials help doctors improve patient care, and sometimes participation in a clinical trial is the patient’s best option. Adequate NCI support for the Cooperative Group Program is critical to advancing progress against cancer and improving the lives of millions of cancer patients.”

ASCO surveyed 509 U.S. and Canadian NCI supported Cooperative Groups to identify the issues influencing enrollment in Cooperative Group trials. The sites planning to reduce participation will include limits on: the total number of patients accrued; the number of trials opened; and the number of Cooperative Group affiliations. Sites planning to limit participation were asked to indicate the reason(s) for their decision, including insufficient staffing, insufficient NCI per-case reimbursement, and other (which allowed a free-text response). Of the 168 sites planning to limit participation, 75 percent of the sites selected insufficient NCI per-case reimbursement as a reason for their decision.

NCI funding for the Cooperative Group Program has been virtually flat since federal fiscal year 2003. Currently, NCI devotes approximately $145 million annually to the program, including $60 million to the $2,000 per-case reimbursement, representing only 1.2 percent of NCI’s FY2009 budget of approximately $5 billion. An ASCO study in 2003 and a C-Change study in 2005 determined that the actual cost of conducting NCI trials was $5000-6000 per case. If NCI reimburses at a more realistic rate of $6,000 per patient, tripling the current amount, this would require an additional $120 million, yet total funding would only account for 3.6 percent of the NCI budget.

The findings also suggest that 39 percent of respondents who indicated they are decreasing participation in Cooperative Group clinical trials plan to increase participation in industry-funded trials. This signifies that sites remain committed to clinical trials but are limiting participation in federally funded trials.

Anecdotal reports indicate that some sites see a necessity to increase industry trials in order to maintain infrastructure, staffing and equipment necessary to conduct trials and remain compliant with rules and regulations. The shift away from federally funded trials could lead to fewer trials of diseases that affect small populations and fewer independent trials, which generate high-quality evidence to guide clinical practice.

As oncology treatments move into an era of highly characterized molecular subpopulations, the national reach of the NCI Cooperative Group Program provides the network critical to accrue sufficient numbers of patients on trials. While funding is not the only factor impacting participation, the significant and growing disparity between actual research costs and the amount provided by NCI to cover those costs serves as a significant deterrent. Without increased funding from the NCI, Cooperative Groups and research sites cannot increase the number of trials, the number of participants enrolled or maintain current infrastructure to support and conduct clinical trials.

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About the Journal of Oncology Practice
The Journal of Oncology Practice is a bi-monthly, peer-reviewed authoritative resource on clinical and administrative management for oncology professionals. The Journal is published by the American Society of Clinical Oncology (ASCO), the world’s leading professional society representing physicians who treat people with cancer.