As the complexity of clinical trials continues to grow, increased data sharing and interoperability will become more important, according to panelists participating at a House Energy and Commerce Committee hearing Wednesday.
The committee's subcommittee on Health held the hearing, entitled "21st Century Cures: Modernizing Clinical Trials," which focused on how to make clinical trials of new drugs and devices in the U.S. more efficient through science and technology.
Jay Siegel, head of scientific strategy and policy at Johnson & Johnson, said some ways to improve trials include standardization, interoperability, researching how best to compile and use data and reassessment of regulations to protect patients. What's more, he called electronic health record adoption necessary to collect data efficiently.
Sundeep Khosla, director of the Center for Clinical and Translational Science at Mayo Clinic, also spoke on the importance of interoperability of EHRs to find participants. He said one way Congress can help with clinical trials is to urge the U.S. Department of Health and Human Services to accelerate the process for interoperability for EHRs.
The Office of the National Coordinator for Health IT currently is working toward healthcare interoperability, but the plan is set to take 10 years. Part of the plan includes clinical data registries, which will be increasingly integrated.
Paula Brown Stafford, president of clinical development at Quintiles, a biopharmaceutical development and commercial outsourcing services company, spoke about the need for sharing of precompetitive data. She said that data helps find the right patients for the right trials, and thus called improved access to information imperative to speedy trials.
Currently, she said, it takes anywhere from 10 months to 4 years to find trial participants; with data as a recruitment tool, she said, it could take as little as 14 days.
It's important for us to be "bringing in data sooner and helping to make those decisions sooner based on the real-world information we have," Stafford said.
Data transparency also was touched on by Aaron Kesselheim, an assistant professor of medicine at Harvard Medical School. Kesselheim said transparency allows groups to share information with one another, and added that the committee and Congress can put in place structures to make sharing of data between groups easier.
Some data, he said, is "held as a trade secret" in some companies, but more data sharing can increase innovative relationships between facilities.
The panelists also briefly touched on HIPAA when it comes to clinical trial data. Siegel said that it is time for a review of the regulation, which was updated in early 2013. Privacy, he said, should be protected, but in ways that facilitate advancement of research.
To learn more:
- check out written testimony from the hearing