A lack of interoperability among electronic health records systems is hindering the ability of registrieslarge databases that collect information on groups of patients treated for a particular medical conditionto extract clinical and outcomes data from EHRs for the medical device approval process.
Despite the dramatic uptake of electronic health information sources, these systems cannot easily transmit data among one another, testified Allan Coukell, senior director of health programs for The Pew Charitable Trusts, on March 24 before the Senate Committee on Health, Education, Labor and Pensions. Instead, registries must develop the ability to extract information from the EHR systems at each facility, or require manual entry from providers.
According to Coukell, there are several barriers to fully achieving the promise of registries in the medical device approval process. One is getting the data into the database, he said. Right now, for a lot of these registries, it requires somebody to hand enter it. In some cases, its taking more time to enter the data in the registry than it is to actually carry out the procedure. So, if we were better at pulling that from the electronic health recordor at least some of the datait would reduce the costs of operating the registries.
Coukell believes that part of the problem is that registries are being built one at a time in a costly way and that we need a sustainable funding model that will let us operate them at lower cost. He pointed to a large, simple trial in Sweden that was successful in randomizing patients through the use of an existing cardiovascular disease registry.
The TASTE trial enrolled more than 7,000 patients, andin unprecedented fashionallowed investigators to keep track of every patient throughout the course of the research at a total cost of $50 per patient, or only $300,000 for the entire trial, Coukell told senators. Conducting a traditional study of this size in the United States would cost hundreds of millions of dollars, if not more.
Why was the Swedish trial so cheap? Because the data for the trial were drawn from a cardiovascular disease registry, Coukell asserts.
He argues that registries have been used to a limited extent in the United States to expedite patient access to new products. However, they are not that common and tend to be costly. Coukell says that in one notable case the U.S. Food and Drug Administration approved an expanded indication for an innovative heart valve based on data from an existing registry, in lieu of a randomized clinical trial.
At the same Senate hearing on Continuing Americas Leadership: Advancing Research and Development for Patients, Michael Mussallem, chairman and CEO of Irvine, Calif.-based Edwards Lifesciences, told lawmakers that his company used such a registry to get one of its productsSAPIEN transcatheter aortic heart valvesapproved for a new use.
In a remarkable effort of collaboration between the medical societies, regulators and other interested stakeholders, the American College of Cardiology and the Society of Thoracic Surgeons helped build what has become one of the most robust clinical evidence and quality measurement tools ever created: the STS/ACC TVT Registry, according to Mussallem. In an unprecedented step, data from the STS/ACC TVT Registry for transcatheter aortic valve replacement procedures were used by FDA in 2013 to help expand the indications for use of our SAPIEN technology, allowing access to a broader patient population.
Mussallem, who testified before the Senate committee on behalf of the Advanced Medical Technology Association, which represents 80 percent of U.S. medical technology firms including companies producing medical devices, diagnostic products and health information systems, called registries very powerful tools that can really work provided that they can be automatically populated so you dont make this another big administrative burden for hospitals.
By being able to collect vast amounts of data on all the patients that are being treated, providers can make some very informed decisions on efficacy and safety for that matter, he concludes.
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