The application of patient registries in the United States by the Federal Drug Administration (FDA) and in the European Union by the European Medicines Agency (EMS), allow these regulatory authorities to monitor the safety and effectiveness of both medical devices and pharmaceutical therapies. The expansion of EMR data exchanges has increased the ability for small and large companies to leverage “real world” patient data to better understand where their products work best, and to discover potential new uses for their therapeutics.
Manufacturers of new devices or therapeutics approved by the FDA or EMS are required to report adverse events to these regulatory agencies. This is often referred to as “post-market surveillance”. In 2017 the FDA launched the FDA Adverse Events Reporting System (FAERS). The FAERS public dashboard is a public interactive web-based tool that gives the public the ability to search the FDA FAERS database. While having such a system helps create transparency around adverse events on any particular treatment – it is limited in that it does not provide information such as how many patients were treated, and what the overall therapeutic benefit was to a particular patient population.
This is where the value of patient registry systems come into play. The FDA has acknowledged that patient registries help ensure the safety and efficacy of devices and therapeutics. An article discussing innovation at the FDA, “FDA Facts: Postmarket Patient Registry Ensures Access to Safe and Effective Devices” reviews some specific examples of how “Registries support the FDA’s ability to learn about potential problems (a process called “device surveillance”) and can therefore improve patient outcomes. They also encourage innovation by allowing manufacturers to collect data more efficiently than via traditional clinical studies, thereby saving manufacturers’ time and money.”
Formalization of Patient Registry Systems
In Europe, the EMS is formalizing guidelines surrounding patient registries. Currently the guidelines are under “public consultation” until December 21, 2020, and the EMS has a goal to finalize documentation in 2021. Per EMS, the goal of the project is as follows: “The European Medicines Agency (EMA) has set up an initiative to make better use of existing registries and facilitate the establishment of high-quality new registries if none provide an adequate source of post-authorisation data for regulatory decision-making.”
As a result, Patient Registry Software systems will continue to grow and become more sophisticated – as both private and public sectors seek to realize the benefits of systems that can allow better treatment and outcomes for patients based on real-world usage.