The Institute of Medicine (IOM), the health arm of the National Academy of Sciences has published a report after reviewing the roles of the various stakeholders involved in cancer clinical trials across the U.S., and recommended a series of changes.
The National Cancer Institute’s (NCI) Cooperative Group Program conducts clinical trials through networks of cancer centers and community oncology practices across the U.S. The IOM’s report emphasizes the need to maintain a robust, standing cancer clinical trials network while improving components that are not working well.
The recommendations of the report were:
- Improving the speed and efficiency of the design, launch and conduct of clinical trials.
- The report called for consolidating many of the administrative functions and processes within the Cooperative Group Program, streamlining government oversight of trials and enhancing collaboration among stakeholders.
- Making optimal use of scientific innovations.
- The Cooperative Group should lead in developing and testing innovative designs for clinical trials that evaluate multiple therapies, combinations of therapies and biomarkers.
- Improving selection, prioritization, support and completion of clinical trials.
- Participating sites should be credentialed to enroll patients in any high-priority trial, and sites with low patient accrual should be eliminated.
- Fostering expanded participation of both patients and physicians.
NCI and other stakeholders should explore and expand approaches for reducing career and financial concerns for the clinical investigators and sites participating in Cooperative Group trials. Among other actions, federal and state health benefits plans, private health insurers and the Centers for Medicare & Medicaid Services should establish consistent payment policies to cover patient care costs (except for specific study-related costs that should be paid for by the drug or device manufacturer) in clinical trials approved through the NCI prioritization mechanism, the report stated.
The report concluded that all stakeholders, including physicians, patients and healthcare insurers, as well as NCI, other federal agencies, academia, foundations and industry, must reevaluate their roles and responsibilities in cancer clinical trials and work together to develop an improved multidisciplinary trials system.