Improving the conduct of cancer trials in the USA

Abstract

Every year, 1·5 million individuals are diagnosed with—and 560 000 die from—cancer in the USA. Some of these patients might experience delay in receiving proper cancer treatment, and some lose their lives unnecessarily. So concludes the new US Institute of Medicine (IOM) report A National Cancer Clinical Trial System for the 21st Century: Reinvigorating the NCI Cooperative Group Program, which highlights the lack of efficiency and effectiveness of the federally sponsored cancer clinical trials system. The US National Cancer Institute's (NCI) Clinical Trials Cooperative Group Program has developed and provided new and improved therapies for cancer patients for half a century. Its ten nationwide cooperative research groups do trials though networks of cancer centres and community oncology practices that enrol 25 000 patients and 14 000 clinical investigators every year. But half these trials do not get completed. Frequently, 2 years elapse between the design, approval, and activation of a cancer trial, and by the time patients are enrolled the trial's concept could have become outdated by new scientific findings. Nor does the existing trial structure encourage collaboration and integration. Unsurprisingly, there is currently no standardised case report system in place, and no mandate exists for a central biorepository. The IOM report emphasises the need for priority funding of those cancer trials with the highest potential of obtaining beneficial outcomes, such as improved survival and quality of life. The document also restates the need for increased participation of cancer patients in trials, which could be possible with a more consistent nationwide health-insurance coverage of cancer care in these trials. Participation of clinical investigators and sites is also to be stimulated by more appropriate reimbursements, rewards, and incentives. If a truly national cancer trial network is to operate efficiently, changes must be adopted by physicians, health insurers, the NCI and other federal agencies, academia, cancer foundations, and industry. Patients deserve to be given high-quality and timely treatments. Ineffective planning, collaboration, and communication are unacceptable barriers to much needed cancer care. The IOM report is a stern judgment on a flagship national research programme. NCI's leadership has been sleeping. A serious response is required.