Leveraging Patient Registries - continued

And, finally, providers and prescribers have stepped up in recent years to demand these data as well, to better support their treatment decisions, organization-wide patient outcomes assesssments, and other measures of the effectiveness of patient care.

Meeting the Demands

With demand growing in virtually every corner of the healthcare arena, attention in recent years has focused largely on patient registries as a viable approach, and solution, to addressing the demands.

Certainly, the various regulatory bodies have expressed an interest in registries, and in better
understanding their appropriate application in addressing product safety and effectiveness and in meeting the post-market commitments. While the agencies have not issued specific statements about the appropriateness of various methodologies, they have demonstrated a growing acceptance of registries as a reasonable approach. Yet still, the answers are not clear. Going forward, then, sponsors must weigh their internal objectives alongside the FDA’s anticipated response, for instance, and find a viable middle ground.

More and more sponsor companies are also recognizing both the value and the challenge in using patient registries to address safety concerns and mandates. Certainly, through their inherently
observational approach, registries offer a valuable methodology for collecting real-world data on a product’s safety in a post-approval setting.

In practice, though, these programs are also being implemented to address both scientific and strategic objectives—often within the same program. They are most commonly supported by a cross-functional team within the sponsor organization, with stakeholders often representing clinical, pharmacovigilance, medical affairs, outcomes research, and marketing groups. And they are driving important scientific publications—and even treatment guidelines—across medicine, supporting both the clinical and market positioning of numerous products.