Health Subcommittee Examines Opportunities to Modernize Clinical Trials

Press Release

The Energy and Commerce Subcommittee on Health, chaired by Rep. Joe Pitts (R-PA), today held a hearing in the 21st Century Cures initiative to discuss opportunities to modernize clinical trials in the effort to accelerate the discovery, development, and delivery cycle of new cures and treatments. Witnesses spoke about how advances in technology, data analysis, and personalized medicine can strengthen clinical trials, safely bringing more effective drugs and devices to patients more quickly and at lower costs.

Dr. Jay Siegel, Chief Biotechnology Office and Head of Scientific Strategy and Policy for Johnson & Johnson commented, "Several opportunities are before us, through advances in clinical trials, to improve the translation of scientific advances into medical advances and patient cures, and to ensure that more of the vast amount of medical data created and recorded every day are used to improve the care of patients and advance medical knowledge. The result will be nothing less than longer and healthier lives."

Dr. Roy Herbst, PhD, Chief of Medical Oncology at the Yale Cancer Center noted, "Clinical trials need to be modernized for the molecular age. Often clinical trials are limited by numerous challenges including the start-up time, accrual, expense, and the need to identify defined sub-populations of patients that makes trial enrollment difficult. Developing a potential therapy from the initial discovery stage through clinical testing and regulatory approval is a complicated, expensive, and often inefficient process that can take up to 15 years. Only by finding better ways to match drugs with patients and studying them in large and diverse populations can we help more patients with this disease and get drugs approved. Modernizing this process with innovative approaches and new clinical trials is of high importance."

Dr. Sundeep Khosla, Dean for Clinical and Translational Science at the Mayo Clinic expressed optimism about the prospects and underscored the need for this to remain a collaborative effort. "The opportunities for bringing new drugs to patients have never been greater, but significant challenges remain. … Legislative policy changes and incentives are necessary to remove specific roadblocks in the clinical trials process. Together, government, the private sector, and academic medical centers must all step up and do all we can to rapidly deliver discoveries to our patients."

William Murray, President and CEO of the Medical Device Innovation Consortium (MDIC), discussed one such collaborative effort that has already shown some success in this effort. "MDIC represents a new, collaborative approach to improving the methods used to regulate new medical device innovations. We believe that our focus on improving regulatory science will offer concrete ways to make patient access to new technologies faster, safer, and more cost-effective. … We believe that clinical trial innovation has the potential to improve the safety and effectiveness of products being introduced into the market, reduce clinical trial timelines and costs, and give U.S. patients earlier access to beneficial innovative technologies."

Paula Brown Stafford, MPH, President of Clinical Development for Quintiles, added, "Recent advances allow for the use of genomics, RNA sequencing, expression analysis, soluble and tissue-based biomarkers, and statistical methodologies to identify appropriate subpopulations. With these technologies, the patients who are most likely to benefit can be identified, optimizing the benefit-risk profile. However, we need FDA's continued acceptance and support of stratifying biomarkers as valid inclusion criteria and Congressional support of collaborative efforts to combine and study existing genomic data, and to encourage ongoing banking of samples."

"We can and must do better because patients deserve better," summed up Pitts.

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