Cancer clinical trials in the USA are "in crisis" according to a new report from the Institute of Medicine, commissioned by the US National Cancer Institute to review its Clinical Trials Cooperative Group after a number of stakeholders expressed concerns that the programme is falling short of its potential to conduct the timely, large-scale, innovative clinical trials needed to improve patient care.
Improved treatments for cancer will be delayed and patient lives will be lost unnecessarily unless the efficiency and effectiveness of the clinical trials system improves, it says, and changes across the board are urgently needed.
The CGP needs to efficiently respond to emerging scientific knowledge; involve broad cooperation of stakeholders; and leverage evolving technologies to provide high-quality, practice-changing research, says the IoM. Four 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
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 Given the pace at which new scientific findings are emerging, a trial concept may become outdated in that period.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 IoM stresses the need to move beyond cooperation to integration by reorganising clinical trial structures and operations into a truly national trials network, including other federal agencies such as the Food and Drug Administration, as well as academic centers, community practices, and the pharmaceutical industry. The NCI should also take the lead in developing and testing innovative designs for clinical trials that evaluate multiple therapies, combinations of therapies, and biomarkers, it says.