“Advances in biomedical research continue to create significant opportunities for improving the detection, treatment, and prevention of cancer,” according to a recent Institute of Medicine (IOM) report titled “A National Cancer Clinical Trials System for the 21st Century: Reinvigorating the NCI Cooperative Group Program.”
These significant opportunities have resulted from collaboration with industry and clinical trials that have tested the safety and therapeutic benefit of promising treatments.
Such clinical trials are essential in translating new knowledge into tangible benefits for patients with cancer—the second leading cause of death in the United States, behind heart disease. This collaboration with industry is also important because it has played a key role in developing new and improved cancer therapies.
Although NCI’s “efforts complement the clinical trials that pharmaceutical and biotechnology companies conduct,” the program has “been falling short of its potential to conduct the timely, large-scale, innovative clinical trials needed to improve patient care,” according to the report.
IOM Report
IOM reviewed the roles of the various stakeholders involved in cancer clinical trials and recommended a series of changes across the board to improve clinical trials by:
– Using a system that efficiently responds to emerging scientific knowledge;
– Involving broad cooperation of stakeholders; and
– Leveraging evolving technologies to provide high-quality, practice-changing research.
IOM feels that by adopting these changes, “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 also “emphasizes the need to maintain a robust, standing cancer clinical trials network by preserving the historical strengths of the Cooperative Group Program while:
· 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; and
· Fostering expanded participation of both patients and physicians
Improving Speed and Efficiency
Since the average time required to design, approve, and activate a cancer clinical trial is two years, IOM recommended that protocol development be coordinated and streamlined by implementing the processes proposed by the Operational Efficiency Working Group.
They proposed reorganizing clinical trial structures and operations into a truly national trials network, expanding drug distribution, and implementing standardized case report forms and remote data capture systems to aid trial efficiency.
This would entail consolidating many of the administrative functions and processes within the Cooperative Group Program, streamlining government oversight of trials, and enhancing collaboration among stakeholders. In doing so, IOM called on federal agencies, academic centers, community practices, and the pharmaceutical industry to work together to improve the system.
Incorporating Innovative Science
To advance progress in clinical trials, IOM recommended 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.
This strategy will allow trials to focus more on the treatment strategy most likely to benefit individual patients, and will allow for more systematic, multidisciplinary, and dynamic approaches when developing standards for new scientific methods and technologies used in trials, to ensure appropriate and consistent use.
Prioritizing and Supporting Trials
To increase the speed of advances in oncology care, IOM recommended that NCI focus on the facilitation of Cooperative Group trials by prioritizing, selecting, and supporting clinical trials and for enrolling patients quickly after a trial is launched. They also want NCI to enroll patients in any high-priority trial, and eliminate sites with low patient accrual.
Patient and Physician Participation
To get the most participation out of trials, IOM recognized the need for adequate reimbursement for physicians and patients, such as reducing career and financial concerns and providing salary support for protected research time. They also called for the system to reward more collaborative work, and to accord more clinical trials at academic medical centers.
Patients also need more consistent coverage from insurance for costs in clinical trials, and IOM asked that CMS 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.
Conclusion
It is disappointing that the IOM which is generally favors all new regulations, has pointed out that our regulatory and clinical trials system is unnecessarily slow.
Given the pace at which new scientific findings are emerging, a trial concept may become outdated in the two years it is being tested, and patients simply cannot afford this setback.
If improved treatments for cancer are delayed, patient lives will be lost unnecessarily unless the efficiency and effectiveness of the clinical trials system improves.
In order to improve this system, all stakeholders, including physicians, patients, and health care insurers, as well as NCI, FDA, other federal agencies, academia, foundations, and industry, must work together.