Unique Challenges for Medical Device Clinical Trials

Medical Device Market Overview 

From glucose meters to artificial heart valves, the medical device industry produces a broad range of diagnostic and therapeutic devices for the treatment and prevention of numerous patient health conditions. 

The FDA uses a class system to rank individual devices as low, intermediate, or high risk — Class I, II, or III, respectively. Higher risk devices face a more stringent Premarket Approval (PMA) process, while other devices will be assigned to follow a process for Premarketing Notification (510(k)) or may be exempt. Additional regulatory paths include Investigational Device Exemption (IDE), Humanitarian Device Exemption (HDE), Postmarket Device Reporting, and Postmarket Surveillance (522PMS).

Medical Device Clinical Trials

Class III (high risk) and some Class II (intermediate risk) devices are required to conduct clinical trials. These Medical Device studies face unique challenges compared to their pharmaceutical counterparts:

• Inability to blind patient and/or practitioner
• “Learning curve” effect for practitioners using new devices
• Operator variability
• Device trial design and selection of endpoints
• Potential malfunctions of device mechanisms

An Endpoint Adjudication Committee can help to address the challenges listed above by providing a source of independent expertise to review Medical Device study data in a consistent manner. Adjudication of events of interest can support overall study integrity and ensure reliable, consistent definitions are provided to regulators and the scientific community.

Endpoint Adjudication is thought to be helpful in studies with the following characteristics:

• Complex and/or subjective endpoints
• Study cannot be blinded
• Global or cultural differences across sites
• Endpoint of interest differs from the investigator’s therapeutic specialty

WCG's Chief Scientific Officer, Dr. Jonathan Seltzer chaired a March 2016 Thinktank Meeting on “The Role of Endpoint Adjudication in Medical Device Clinical Trials”, hosted by the Cardiac Safety Research Consortium (CSRC) and MDEpiNet with a great deal of FDA participants. At the event, it was recommended that the majority of medical device studies be adjudicated.

WCG's ACI Clinical’s Device Adjudication Model

ACI Clinical recognizes there are many nuances in medical device adjudication compared to clinical drug trials. In general, device studies are often smaller, shorter and less expensive than clinical trials. ACI has therefore built a device adjudication model that is faster and cheaper than the traditional drug adjudication models. In addition, ACI works collaboratively with sponsors at the project start to understand their true objectives, whether it may be to gain regulatory approval, to gain reimbursement, or simply to promote awareness and recognition through publications, etc. ACI uses this information to develop and implement a cost certain, standardized adjudication process to effectively deliver what is needed for the sponsor.

As an industry-leading provider of clinical trial expert committees and clinical safety and consulting services, ACI Clinical is available to support and assist you with any Medical Device trial Endpoint Adjudication or clinical consulting needs. ACI brings clients the largest dedicated committee staff in the industry, a global network of qualified medical experts that can serve as members, and a proprietary technology designed for adjudication workflows.