Increased data sharing and greater interoperability of electronic health records are needed to modernize and improve Americas clinical trial process, according to witnesses who testified at a July 9 congressional hearing.
The House Energy and Commerce Subcommittee on Health examined how improvements to clinical trials can accelerate the discovery, development, and delivery cycle of new cures and treatments. The problem is that fewer new drugs reach patients each year, argued subcommittee chairman Joseph Pitts (R-Penn.), and on average it takes about 14 years and $2 billion to bring a new drug to the market, with a large portion of the cost spent on recruiting and retaining subjects for clinical trials.
It is often difficult to identify potential participants, due to a shortage of centralized registries, low awareness of the opportunity to participate in clinical trials, low patient retention and lack of engagement among community doctors and volunteers, said Pitts. In many cases, researchers have been slow to utilize technology, such as electronic health records and web-based platforms in their trials, which is also a barrier to greater collaboration and information sharing.
Jay Siegel, M.D., chief biotechnology officer at Johnson & Johnson testified before the subcommittee that despite massive amounts of valuable medical data being generated and recorded every day, only a tiny fraction is being used to advance the health and welfare of patients by enhancing medical knowledge. Siegel argued that the adoption of EHRs and EHR-based trials provide the potential to collect data efficiently in the settings in which healthcare is being delivered, creating a learning health system.
Large scale registries of patients with a shared condition can be constructed allowing studies of disease course, risk factors, biomarkers and treatment defects, he said. The powerful tool of randomization could be applied to such cohorts, creating large simple clinical trials in the care setting. The resultant enhancement of the ability to learn about the effects of medicinal products while in clinical use could allow earlier availability of important new therapies with assurance that additional information would be collected reliably and efficiently at approval.
Siegel asserted that what is needed for EHR-enhanced research to fully realize its potential is the standardization, interoperability and data quality of EHR systems, determining how best to compile and use the data, as well as a reassessment of the regulatory frameworks that protect patients.
Sundeep Khosla, M.D., director of the Center for Clinical and Translational Science at the Mayo Clinic, told lawmakers that much greater EHR interoperability is needed. This could facilitate, for example, a study investigators search across all 62 [Clinical and Translational Science Awards] sites and beyond for the potential pool of study participants at various centers, which--with appropriate privacy protections--could allow her/him to select the ones where the study could be most rapidly conducted, testified Khosla. Interoperability is also critical for other types of outcomes research, including comparative-effectiveness research in real work clinical practice.
Paula Brown Stafford, president of clinical development at Quintiles, a contract research organization that conducts clinical trials, believes that all EHR systems in the U.S. should be interoperable to allow a free flow of longitudinal health data. This would allow real-world outcomes to be discerned much more quickly, allowing risk/benefit assessment to be carried out on millions of patients in near real time, said Stafford. This would transform the way we do clinical trials, giving access to patient data from all sources--doctors office, urgent care, pharmacy clinics, hospitals, secondary, tertiary care centers--allowing complete tracking of patient care and outcomes.
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