Building on a Strong Foundation
The IOM’s report, A National Cancer Clinical Trials System for the 21st Century: Reinvigorating the NCI Cooperative Group Program, reviews the roles of the various stakeholders involved in cancer clinical trials and recommends a series of changes across the board. The report’s authoring committee envisions a dynamic system that efficiently responds to emerging scientific knowledge; involves broad cooperation of stakeholders; and leverages evolving technologies to provide high-quality, practice-changing research. Clinical trial participation would be desirable for patients and physicians because it would provide access to innovative therapies that reflect patient preferences and are reimbursed. The report emphasizes the need to maintain a robust, standing cancer clinical trials network by preserving the historical strengths of the Cooperative Group Program while improving components that are not working well. The following overarching goals should guide improvement efforts:
- Improving the speed and efficiency of the design, launch, and conduct of clinical trials
- Making optimal use of scientific innovations
- Improving selection, prioritization, support, and completion of clinical trials
- Fostering expanded participation of both patients and physicians
Improving Speed and Efficiency
Clinical trials are complex endeavors that involve hundreds of steps and lengthy, iterative review processes by multiple oversight bodies with varying objectives and responsibilities. Inefficiencies in the processes used to develop, launch, and conduct clinical trials often lead to long delays. The average time required to design, approve, and activate a cancer clinical trial is two years. Given the pace at which new scientific findings are emerging, a trial concept may become outdated in that period. The committee recommends that protocol development be coordinated and streamlined by implementing the processes proposed by the Operational Efficiency Working Group.
The committee stresses the need to move beyond cooperation to integration by reorganizing clinical trial structures and operations into a truly national trials network. Among its recommended actions for improving overall operations, the report calls for consolidating many of the administrative functions and processes within the Cooperative Group Program, streamlining government oversight of trials, and enhancing collaboration among stakeholders. NCI should lead in instituting the necessary changes, but other federal agencies such as the Food and Drug Administration, as well as academic centers, community practices, and the pharmaceutical industry, will need to be involved in improving the system. NCI also should expand drug distribution and implement standardized case report forms and remote data capture systems to aid trial efficiency.
Incorporating Innovative Science
Progress in the treatment of cancer patients depends on the effective incorporation of scientific advances into clinical trials. For example, to achieve the goals of targeted cancer therapy, biomarkers (predictors of a response to a particular therapeutic intervention) increasingly are being used to select which treatment strategy is most likely to benefit individual patients. To advance this field, NCI should, among other actions, mandate that biospecimens collected from patients in the course of Cooperative Group trials be submitted to standardized central biorepositories supported by a national inventory and a defined peer-review process for accessing specimens for study.
The Cooperative Groups should lead in developing
and testing innovative designs for clinical trials that evaluate multiple therapies, combinations
of therapies, and biomarkers. The National Institutes of Health, including NCI, should take a more systematic, multidisciplinary, and dynamic approach when developing standards for new scientific
methods and technologies used in trials, to ensure appropriate and consistent use.