The U.S. House of Representatives Committee on Energy and Commerce's Subcommittee on
Health held a hearing entitled "21st Century Cures: Modernizing Clinical Trials" last week.
The bottom line is that the clinical trials process has a long way to go toward becoming an efficient process for bringing treatments and medical devices patients. The need to get therapies to market has to be balanced with ensuring that those drugs, devices, and other treatments are safe for patients.
Enter electronic medical records (EMR).
A study in the UK showed that EMRs can play a role in getting the right treatments to the right patients at the right time and at lower cost.
"Researchers installed a new computer program in 23 approved general practitioner surgeries across England and Scotland. The program was able to identify which patients were eligible to take part and allowed doctors to sign up relevant participants.[...]Researchers then used the patients’ [EMR]s, as recorded in the Clinical Practice Research Datalink, the NHS observational data and interventional research service, to monitor the impact of the treatments they had been prescribed."
In her testimony before the House committee, Paula Brown Stafford, president of clinical development at Quintiles proposed an EMR-enabled future of clinical development:
"...a digital, global model, which the industry is making some small strides toward, design is informed by real-world large, de-identified datasets and performance and productivity metrics, with patient recruitment taking advantage of the Internet and social media. The right patient would be identified by prescreening through data collection instruments served through the Internet, and trials would be conducted by collecting data directly from EMRs or through data collected at point of care that is integrated with EMRs. Data would then be housed within HIPAA-compliant e-Source archives, accessible for real-time access, remote monitoring, and application of signal detection analytics to allow 7 “just-in-time” assessment of safety and protocol compliance. Interim data would be available within hours, and safety demonstrated through immediate access to real-world data."
Video of the entire hearing is available online here, along with links to other witnesses' testimonies. A short video of commitee chairman Fred Upton (R-MI) and Representative Diana DeGette (D-CO) announcing their joint initiative, "A Path to 21st Century Cures" is below.
Image Credit: via Flickr St. Louis University Madrid, used under a Creative Commons license.
