The Value of Registries in Post-Market Surveillance

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:

• How is a device or drug actually used in real-world settings?
• What does the average patient look like?
• How does a product truly perform?

Let’s dig into how registries are used in post-market surveillance, starting with some key definitions. In this post we will cover:

• What Is Post-Market Surveillance?
• What Are the Goals of Post-Market Surveillance?
• What Is the Value of Post-Market Surveillance?
• How Do You Conduct Post-Market Surveillance?
• How Do Clinical Registries Drive Post-Market Surveillance?

What Is Post-Market Surveillance?

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.

What Are the Goals of Post-Market Surveillance?

Pharma and medical device companies rely on the real-world insights they gain through post-market surveillance activities to:

• Detect adverse events or risks as they arise during real-world usage of a device or drug.
• Compare new products or treatments with existing options and the standard of care.
• Update clinical guidelines as certain populations or groups find more benefit than others.
• Comply with regulatory requirements.

There are many different aspects of a device or product that are assessed in post-market surveillance. A few examples include:

• Clinical effectiveness: Use data from real-world clinical settings to examine the relative effectiveness of a device or drug in a large, diverse patient group to compare that product to the standard of care or competition.
• Adverse events and side effects: Leverage real-world evidence to identify risks or adverse reactions that might have been missed in the initial clinical trial for a device or drug.
• Utilization: Examine how a product is actually used in the real world, which can be different than what is approved or marketed.

What Is the Value of Post-Market Surveillance?

Real-world evidence delivered through post-market surveillance offers differing importance for different stakeholders.

How Do You Conduct Post-Market Surveillance?

Let’s break down the U.S. FDA’s definition of post-market surveillance into three parts:

1. Data Collection
2. Data Analysis
3. Data Interpretation

Step 1: Data Collection for Post-Marketing Surveillance

You need the right data sources 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:

• Medical record data such as the electronic health record (EHR), clinical trials, lab results, imaging studies, and pharmacy prescriptions.
• Patient generated data like patient-reported outcome (PRO) surveys or wearable biometric devices like smartwatches and smartphones.
• Payer and regulatory data such as billing and insurance claims.
• Registry data from industry, disease, patient, or medical specialty registries.

These data are collected in two primary ways:

1. Machine-to-machine data connection allows you to securely and efficiently collect real-time data from any number of systems, including electronic health records and administrative claims.
2. Human-to-machine data collection allows you to capture essential care details and specialized information with electronic case report forms. It also allows you to collect patient-reported outcomes or gain insights directly from patients, clinicians, and others through web-based surveys.

Step 2: Data Analysis for Post-Marketing Surveillance

Step 3: Data Interpretation for Post-Marketing Surveillance

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:

1. To ensure timely and accurate interpretation of data, you need statistically-adjusted reports that are available in real-time. This helps you quickly and easily measure and understand clinical outcomes, determine patient quality of life, and understand the total financial impact of the intervention.
2. Statistically-adjusted reports should be built using key risk and reliability adjustment methodologies that are essential to success in maximizing data value.

How Do Clinical Registries Drive Post-Market Surveillance?

Clinical data registries are uniquely useful in their ability to facilitate post-market surveillance for three reasons.

1. They advance post-market surveillance activities to help us better understand the real-world safety and effectiveness of procedures, treatments, and devices.
2. They solve complex problems for device and pharma companies. These organizations in general are faced with complex barriers when seeking real-world data for purposes of research and development, quality improvement, or regulatory requirements.
3. They deliver the comprehensive technology needed to build a registry that collects real-world data, transform it into real-world evidence, and make it accessible and useful for decision-making.

Example of Registries and Post-Market Surveillance

There are a few ways medical device and pharma companies are using registries to support their post-market surveillance programs.

• Accessing data from an existing registry
• Partnering with an existing registry that is running registry-based clinical trials
• Leveraging registry technology to support a registry-based study
• Creating new registries and using existing registry data to support a full post-market surveillance program

We can illustrate these with a few examples.

Accessing Data from an Existing Registry

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.

Partnering with an Existing Registry on Registry-Based Clinical Trials

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.

• G-MINOR focuses on the impact of a genomic biomarker on adjuvant treatment decisions among patients with high risk prostate cancer.
• G-MAJOR — supported by the National Institutes of Health — aims to understand the clinical utility of genomic classifiers in newly diagnosed favorable-risk prostate cancer patients.

Leveraging Registry Technology to Support a Registry-Based Study

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, BARHEMSYS®, 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.

Industry-Leading Registry Technology for Post-Market Surveillance

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.

ArborMetrix offers an industry-leading, proven registry solution for post-market surveillance that meets the needs of medical device and pharma companies, medical specialty societies, and clinicians.

If you have any questions or would like to learn more about our registry solutions for post-market surveillance, contact me at sheaton@arbormetrix.com.

References

1. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?fr=822.3
2. Gan TJ, Diemunsch P, Habib AS, et al. Consensus guidelines for the management of postoperative nausea and vomiting. Anesth Analg. 2014;118(1):85-113.