Clinical data registries are useful across many parts of healthcare. One of their most valuable purposes is post-market surveillance.
Registries are designed to collect, analyze, and interpret large amounts of real-world data. This triad sets the foundation for successful post-market surveillance. When these three are done well, the result is a vast data resource that provides real-time, ongoing data collection, and is a central source of truth to answer key questions like:
Let’s dig into how registries are used in post-market surveillance, starting with some key definitions. In this post we will cover:
Post-market surveillance (also called post-marketing surveillance) demonstrates the real-world safety and effectiveness of medical devices and pharmaceuticals.
The U.S. Food and Drug Administration (U.S. FDA) defines it as “the active, systematic, scientifically valid collection, analysis, and interpretation of data or other information about a marketed device.”1
This definition underscores that post-market surveillance is an active, ongoing process – not a one-off. It also emphasizes data science as a critical part.
The European Medical Device Regulation (E.U. MDR) defines it as “all activities carried out by manufacturers in cooperation with other economic operators to institute and keep up to date a systematic procedure to proactively collect and review experience gained from devices they place on the market, make available on the market or put into service for the purpose of identifying any need to immediately apply any necessary corrective or preventive actions.”
Similar to the U.S. FDA, the EU MDR also highlights the need for a post-market surveillance system that provides up-to-date insights. But it goes a step further to call out the importance of using those insights to make adjustments and improvements.
Pharma and medical device companies rely on the real-world insights they gain through post-market surveillance activities to:
There are many different aspects of a device or product that are assessed in post-market surveillance. A few examples include:
Real-world evidence delivered through post-market surveillance offers differing importance for different stakeholders.
For medical device and pharmaceutical companies, post-market surveillance can provide information on how a given product performs relative to others. Companies can then tweak marketing and pricing strategies accordingly and develop new and improved products.
For clinicians and provider organizations, post-market surveillance can provide information on how products perform relative to others in the context of real-world patient populations, which are often materially different from clinical trial populations. This can then inform treatment decisions, including off-label use of products.
For payers and regulatory agencies, post-market surveillance can shed light on which products and drugs are the safest and most cost-effective. This can then inform coverage and reimbursement decisions.
Let’s break down the U.S. FDA’s definition of post-market surveillance into three parts:
These are the steps to conducting post-market surveillance for medical devices and drugs.
You need the right sources of healthcare data and the right technology to collect data efficiently, securely, and accurately for post-market surveillance activities.
These data can come from several sources, such as:
These data are collected in two primary ways:
The technology you use to get this data matters. You need an efficient and secure way to collect large amounts of real-world data and prepare it for analysis.
Once you collect data for a given device or product, the next step is transforming it into real-world evidence. This involves combining, blending, validating, and analyzing various data sources. These analyses can be risk- and reliability-adjusted according to the data ingested, and then presented to stakeholders in an interactive and engaging way.
Once you are collecting and analyzing data, you need a way to interpret the data easily and readily. Here are a few things to keep in mind:
Clinical data registries are uniquely useful in their ability to facilitate post-market surveillance for three reasons.
There are a few ways medical device and pharma companies are using registries to support their post-market surveillance programs.
We can illustrate these with a few examples.
Medical device companies that develop products used for extracorporeal membrane oxygenation, commonly referred to as ECMO, are leveraging clinical data from a centralized registry managed by the Extracorporeal Life Support Organization (ELSO).
ELSO’s Quality Registry is the largest source of real-world data on ECMO in the world. It tracks the use of medical devices for ECMO, and it contains details on devices and patient demographics, clinical information, patient outcomes, and adverse events.
Device manufacturers leverage data from the ELSO Quality Registry through a device registry called ELSO Evidence Explorer. They have access to de-identified real-time data from more than 700 centers worldwide. Companies use this information to know how clinicians are actually using their devices, what the average patient looks like, and how their device truly performs in the real-world.
The Michigan Urologic Surgery Improvement Collaborative (MUSIC) has a long-standing clinical registry they use to identify opportunities to improve processes of care, develop strategies for quality improvement, and monitor the success of quality improvement interventions.
MUSIC runs a few registry-based randomized clinical trials to advance its research mission.
Acacia Pharma is a hospital pharmaceutical company focused on the development and commercialization of new products aimed at improving the care of patients undergoing significant treatments such as surgery, other invasive procedures, or cancer chemotherapy.
Their latest product is a new therapy for postoperative nausea and vomiting (PONV). PONV has been cited as the most undesirable of all surgical complications, even worse than pain, in some patient surveys.2 It is a common complication of surgery and anesthesia that occurs in approximately 30% of surgical patients and up to 80% of high-risk patients.
Acacia is leveraging registry technology to support a registry-based observational study called PROMPT (PONV Rescue Outcomes after aMisulPride Treatment). As a large observational patient dataset, PROMPT will collect RWE on the presentation, evaluation, and rescue treatment of PONV.
As medical technology and research continues to advance, the importance of tracking and reacting to real-world evidence through post-market surveillance will only continue to grow. Registries will play an integral part in this process, and their analytic potential will serve as an essential asset for patients, providers, and industry partners alike.
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