Improving Access to Medical Devices: FDA Uses Existing Clinical Data to Reduce Premarket Data Needs

By: Ben Fisher, Ph.D.

At the FDA, we recognize the value of encouraging medical device innovation. We recently have acted to reduce the time and cost of clinical trials while maintaining patient protections. By doing so, FDA is helping to ensure that manufacturers will be more likely to conduct their clinical studies in the U.S., and patients in this country will have earlier access to innovation.

Ben FisherOne way the FDA can reduce the time and cost of a clinical trial is to determine if publicly available clinical data for medical devices with which we have considerable experience can be leveraged to develop a less burdensome clinical trial design. For example, take the case of global endometrial ablation (GEA) devices, used to treat heavy menstrual bleeding by applying heat or extreme cold to the inner lining of the uterus.

Since 1997, the FDA has approved five GEA devices based on the results of randomized clinical trials (RCTs) of 250-350 women in each trial. The participants were assigned to a group that received treatment with a new GEA investigational device or to a control group treated with rollerball ablation, an older, well-known technology for treating heavy menstrual bleeding.

Each of the RCTs shared similar study and control populations, study design, and endpoints. Those characteristics, combined with the consistent performance of the roller ball ablation device (the control device) across the RCTs, prompted the FDA to assess whether we could leverage the RCT data to help support a less burdensome clinical trial design for future premarket approval applications for GEA devices.

With input from industry and members of the FDA Obstetrics and Gynecology Devices Advisory Panel, the FDA was able to apply a statistical analysis model, called an objective performance criterion (OPC), to determine the minimum acceptable success rate for demonstrating device effectiveness. The FDA will post detailed information on how we developed this OPC on our website soon.

The FDA’s development of an OPC means that less burdensome clinical trial designs without a control group may be appropriate for clinical studies of GEA devices, resulting in studies that require fewer subjects, thereby reducing the length and cost of such clinical trials compared with RCTs.

In addition, development of an OPC may help encourage subjects to enroll in these clinical trials since all study subjects would undergo treatment with the investigational device.

The FDA has established a strategic priority of strengthening the clinical trial enterprise. This includes finding ways to streamline clinical trials so that fewer resources are required to bring a new device to the market.

Through strengthening the clinical trial enterprise, we hope to encourage manufacturers to study new and important medical devices in the U.S., helping us fulfill our vision of providing patients with high-quality, safe and effective medical devices of public health importance first in the world.

Ben Fisher, Ph.D., is FDA’s Director, Division of Reproductive, Gastro-Renal, and Urological Devices, in the Office of Device Evaluation at the Center for Devices and Radiological Health

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