The uneven laws and regulations create disparities in patient access to phase I trials and deny many patients the opportunity to try a novel therapy and contribute to knowledge about their disease.
— Jeffrey S. Weber, MD, PhD
ASCO has released a policy statement calling for greater access to and education about phase I clinical trials, the first-in-human studies of new agents designed to fight cancer.
In “The Critical Role of Phase I Trials in Cancer Research and Treatment” ASCO policy statement, the Society stresses the critical importance of phase I clinical trials in cancer research and treatment. The statement emphasizes that this research offers greater potential as a treatment option for many patients than was the case in the past, due to development of molecularly targeted agents, biomarker tests to identify patients likely to respond to treatments, and innovative clinical trial designs.
The ASCO policy statement reviews evidence that shows patients who participate in phase I trials may experience improved quality of life, psychological advantages, and direct medical benefits. Yet, according to the Society, significant barriers, including insurance coverage, discourage patient enrollment in research.
“The uneven laws and regulations create disparities in patient access to phase I trials and deny many patients the opportunity to try a novel therapy and contribute to knowledge about their disease,” said the statement’s lead author, Jeffrey S. Weber, MD, PhD, a member of the ASCO Cancer Research Committee. “[The Centers for Medicare & Medicaid Services] should address these disparities and fix these gaps.”
Phase I clinical trials are an important step in translating basic research into clinical practice. Researchers use these studies to determine the recommended dose and schedule of an investigational agent, observe its therapeutic effect, and assess its safety profile. Additional phase I studies, called phase Ib, may also be used to evaluate new schedules of existing agents or combinations of new agents with established agents or radiation.
In addition to specifically focusing on the special issues related to conducting phase I trials in children, the ASCO policy statement recommends concrete steps be taken to creating a health-care delivery and payment system and expanding educational efforts that support decisions by patients to participate in these trials. ■
© 2015. American Society of Clinical Oncology. All rights reserved.