Thursday, April 15, 2010

IOM Report - US Cancer Clinical Trials Network Has Broken

The latest news from the Institute of Medicine is a report about the dysfunctional NCI Clinical Trials Cooperative Group in the US, a topic breast cancer activists have been discussing for a while.

Below is the text of IOM's press release

Overhaul of NCI Cooperative Group Program Needed to Ensure

It Can Continue to Conduct Important Cancer Clinical Research

WASHINGTON -- Because a robust national clinical trials network is essential to achieving advances in cancer treatment and prevention, the National Cancer Institute (NCI) should preserve and strengthen the capabilities of the Clinical Trials Cooperative Group Program through an overhaul of its organization, management, and funding, says a new report of the Institute of Medicine. The program has been instrumental in establishing many therapies routinely used to treat cancer patients, said the committee that wrote the report. But it faces many difficulties at present that undermine its ability to facilitate the multi-institutional collaborations necessary to conduct large, late-stage trials that answer important research questions single institutions and the private sector cannot or do not tackle.

Inefficient processes for developing trials, complicated government oversight, and a lack of sufficient resources hinder the program's ability to efficiently and effectively design and conduct trials, the committee concluded. To reduce waste and streamline the program, the report calls for consolidating redundant administrative and support functions that are handled separately by each of the 10 cooperative research groups that comprise the program. It recommends strategies to more effectively incorporate scien­tific advances into clinical trials and a boost in funding and other incentives to encourage and support health professionals' participation in studies. And it urges public and private health plans to fully cover the nonexperimental costs of study participants' health care during trials to eliminate financial disincentives that lead patients to decline enrollment or to drop out.

"Cooperative group studies have steadily improved the care of cancer patients for more than 50 years, but the program is at a breaking point," said committee chair John Mendelsohn, president of the University of Texas M.D. Anderson Cancer Center in Houston. "Its effectiveness is being undermined at a time when the opportunity for improving cancer care has never been greater because of rapid advances in biomedical research. A few isolated or partial measures won't suffice. The program urgently needs changes across the board if it is going to continue producing the kind of studies necessary to answer crucial and fundamental questions about how to successfully treat and prevent cancer, which can't be answered through other means."

The Cooperative Group Program involves more than 3,100 institutions and 14,000 investigators who enroll more than 25,000 patients in clinical trials each year. Research by the cooperative groups has contributed to the introduction of treatments and drug indications that have led to improved survival for cancer patients.

Successful trials depend on sufficient involvement by physicians and other health professionals. Cancer care providers devote significant amounts of time and effort to recruit patients into trials and manage their care during the studies. Inadequate reimbursement and recognition for their efforts are increasingly deterring their willingness to initiate or participate in trials, the report concludes.

The committee called on NCI to increase the amount it reimburses clinicians for the costs of managing each of their patients in trials, and to pay for their time and effort spent on designing and carrying out clinical trials. Medical centers should take into account health professionals' participation in clinical trials during their consideration for tenure and promotions. NCI should establish a centralized credentialing system for investigators and sites that wish to participate in a national trials system to increase consistency across sites and eliminate the burden of recredentialing with different cooperative groups. This system also would provide a way to eliminate research sites with low levels of recruitment or inadequate data management capability.

Insurance providers' variable and uncertain coverage of patients' care during studies and overly restrictive eligibility criteria deter patient involvement in clinical trials. The committee called on public and private health plans to cover all nonexperimental costs of participation in clinical studies. Patient eligibility criteria should allow the broadest participation possible to facilitate more rapid recruitment and allow broader generalizations about study results to be made. Greater involvement by patient advocates could help facilitate this change, the committee added. Advocates can provide valuable input to study design and procedures, safety and confidentiality issues, and other factors important to potential research participants.

Funding for the Cooperative Group Program is lower now in inflation-adjusted dollars than it was in 1999, and constitutes less than 3 percent of NCI's total budget. Current funding is insufficient to support the number of trials the groups undertake, especially as trials are becoming more complex with a new focus on developing therapies tailored to the molecular and genetic characteristics of individual patients' cancers. NCI should allocate a larger portion of its research portfolio to the program, and if adequate funding is not available, cooperative groups should reduce the number of NCI-funded trials undertaken to a quantity that can be fully supported.

The report was sponsored by the U.S. Centers for Disease Control and Prevention, Food and Drug Administration, National Cancer Institute, American Society of Clinical Oncology, Association of American Cancer Institutes, and C-Change. Established in 1970 under the charter of the National Academy of Sciences, the Institute of Medicine provides independent, objective, evidence-based advice to policymakers, health professionals, the private sector, and the public. The National Academy of Sciences, National Academy of Engineering, Institute of Medicine, and National Research Council make up the National Academies. A committee roster follows.

Link to news story

Link to IOM Press Release

Link to IOM Report