Registries are an increasingly popular tool for gathering population-level data on a particular medical device or therapy, but given their complex nature and potentially high cost they may not be the best way to get the information needed.
In a conference call this morning AdvaMed officials and industry partners highlighted some of the major components of the group’s new guidelines for medical device registries, including so-called "threshold questions" for determining whether a registry is necessary or wise to begin with.
The registry threshold is dependent on 4 primary considerations, according to the new guidelines: method, cost, tools and commitment.
Between clinical trials, FDA post-market requirements, medtech reporting requirements and other existing methods of gathering data on medical devices and the clinicians who use them, a registry may not be necessary, Edwards Lifesciences (NYSE:EW) government affairs vice president Barry Liden, who helped craft AdvaMed’s new principles, said during today’s call.
"There’s a lot of ways to collect data and, as time goes on, increasingly easier ways to collect this kind of information," Liden said. "The 1st threshold question asks, with all these current collection methods available, is the new registry really necessary to answer the specific scientific questions we want to answer?
The next question is one of cost: Are the objectives of the proposed registry worth the cost in terms of funding, personnel and burden on the healthcare system? The costs of a registry can vary wildly from one to the next, depending on the technology in question, the size of the registry, the methods of data collection and a host of other considerations, but the task is not one to be undertaken lightly.
"We really need to make sure before we decide to do registries that we answer the objectives that are going to be answered," Liden said. "These scientific questions we set up in advance need to be important enough to warrant and justify the increased cost that’s going to be put on our hospitals and onto our healthcare system."
The 3rd question relates to the tools needed to conduct the registry, and whether such instruments are reliably available. Whether the registry requires little more than a paper form filled out during a procedure or whether it involves advanced electronic data entry mechanisms, without the means of collecting and analyzing data it may not make sense to launch a registry, according to the call.
The final component, and perhaps the most important, relates to long-term commitments to fund and maintain a registry, involving stakeholders from across the healthcare spectrum.
"Long-term success in any registry depends on all the stakeholders: industry, regulators, physicians, hospitals, consumers, patient groups, everyone providing their support," Liden said. "Many groups benefit from the data generated by a registry, so it’s appropriate that all parties have some stake in its development."