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Guest Commentary: GI coordinated registry network makes a case for obesity devices
In this guest commentary, Deborah A. Fisher, MD, MHS, associate professor of medicine at Duke University and associate director of GI research at Duke Clinical Research Institute, discusses the topics examined at the recent FDA conference on gastrointestinal devices and the value of a national evaluation system for medical devices.
Health care providers, regulators and industry agree that it takes too long for new medical devices to come to market. Further, many feel the cost is too high and the resulting data are not applicable to real world use. It is a strategic goal of the Center for Devices and Radiological Health (CDRH) at the FDA to establish a national evaluation system for medical devices that will increase access and use of real-world evidence to support regulatory decision making.
Deborah A. Fisher
To create a functional national system, many smaller steps need to be accomplished to establish coordinated networks and to pilot data collection and sharing methodology. With a focus on bariatric interventions, stakeholders from the FDA, industry, patient advocacy and academia came together to discuss GI devices in the context of work toward the larger national system goal.
Why start with obesity?
There are more than 90 million people with obesity in the U.S. Obesity cuts across all races, ethnicities and socioeconomic statuses. Obesity rates continue to increase and annual health care costs for obesity and obesity-related illnesses approach $150 billion. Health care systems have treated obesity as an acute problem when it is a chronic disease. Recidivism or weight regain occurs in 20% to 30% of patients after gastric bypass and 22% to 55% of patients 5 years after a sleeve gastrectomy.
Weight loss interventions accomplished via surgery, endoscopy or medication are different but they can complement each other in the treatment of a complicated disease that progressively worsens if left untreated. In addition, multiple modalities allow the opportunity to treat the spectrum of patients with obesity and provide patient choices in expected risk and benefit.
Challenges in obesity research and evaluation
Many challenges in obesity data collection reflect the challenges in device data collection more broadly, but there are some challenges that are particular to obesity. Joe Nadglowski of the Obesity Action Coalition presented the patient view, sharing that a singular “patient perspective” on meaningful weight-loss or tolerable risk level does not exist.
Many individuals with obesity do not consider themselves patients. Most people with obesity have not accepted the value of modest weight loss (3%-10%) and unrealistic expectations are a significant problem. Further, there is stigma associated with obesity that leads to bias and discrimination against people with obesity and impacts their care. The language we use matters and People First Language is recommended for projects related to obesity. By using “individual with obesity” instead of “obese individual” we avoid equating a person with their condition.
Challenges in device studies, registries
Laura Eaton, RN, BSN, CCRN-R, at Apollo Endosurgery spoke on the challenges of data collection for GI devices regarding regulatory decisions. The pivotal randomized controlled trials of devices are typically small, costly and have limited long-term follow-up. In addition, there are not standardized outcome measures to help facilitate comparisons across interventions. For example, weight loss interventions are inconsistently measured across studies and specialties as total weight change, total BMI change, excess weight change and excess BMI change.
Long-term data (5 years) are difficult to collect as are the economic data needed to support coverage and coding. The post-approval studies often mirror the pre-approval pivotal trials and are without a mechanism to collect off-label uses. Therefore, the post-approval data are not representative of real world patients or real world use of the device. Further, most of the current registries related to GI conditions are tied to surgical center accreditation. For example, the Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program is limited in collection of endoscopic devices and limited to procedures performed at Bariatric Surgery Centers of Excellence. Finally, device manufactures have had limited access to the data or reports of these registries.
Use of real world data in regulatory decisions
While there are certainly challenges to creating a national medical device evaluation system — essentially a network of registries — there many more potential benefits. Owen Farris, PhD, director of Clinical Trials Program, Office of Device Evaluation, CDRH, FDA, listed several of these benefits including:
- Shorter time for new devices to reach the market and a lower pre-market burden of data collection because there would be confidence the post approval data collection;
- Increased efficiency and decreased expense of having an evaluation structure that does not need to be assembled and then discarded for each device as trials or single-use registries typically are; and
- Ability to use real world data can facilitate premarket indication expansion, allow study of iterative improvements to approved devices, identify and clarify safety signals, and support coverage and reimbursement decisions.
Summary
The attendees agreed on the value of work toward a pilot project in obesity devices to support the longer term goal of a national medical device evaluation system. Common themes throughout the conference included the need to standardize data elements for medical devices; producing data extraction and query protocols that could be used in multiple electronic systems such as existing registries and electronic health records; and the importance of patient engagement throughout the process including use of patient reported outcomes, patient input for variable selection and data collection and patient facilitation of long term follow-up.
As a physician and researcher I welcome the potential end of, or at least reduction in, duplicate work. When I see patients in clinic or for endoscopy, I enter information in an electronic health record for clinical documentation. While conducting clinical research, I or my team often enter very similar data into electronic case report forms. These parallel systems are redundant and wasteful.
In addition, data collected for billing often lack important clinical details, but these details should be available in the documentation for clinical care, further advancing research opportunities at lower costs and higher efficiency than current practices. However, my excitement at the possibilities is always tempered with caution for patient privacy and protection. Patients will ultimately benefit from having effective devices reach the market sooner and discovering safety signals faster, but they must be a voice and active participant in how this is accomplished.
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