Clinical trials for medicine and medical devices share similar challenges, including process inefficiencies and approval delays, but collaborative stakeholders can help seize opportunities to improve these trials for everyone involved, according to two review papers published in Oct. 17 in the Journal of the American College of Cardiology (JACC).

Randomized clinical trials (RCTs) are the benchmark to determine therapeutic efficacy and safety. However, as large clinical outcome trials in cardiovascular disease have proliferated, so have their complexities, according one review paper which looked at the changing landscape of RCTs in cardiovascular disease.

“The increasing complexity of trial protocols; long timelines for budget negotiations, contracting, and institutional review board approval; and other logistical difficulties have created an atmosphere of obstruction, rather than facilitation, of clinical research in the U.S.,” assert W. Schuyler Jones, MD, et al. In addition, many clinical trials now rely on enrollment outside of the U.S. due to rising costs, lack of engagement of patients, clinicians, and investigators, and other obstructions. 

In response to these challenges, many stakeholders, including professional societies, academic research organizations, industry sponsors, regulatory agencies, and funding agencies, have begun developing and refining methods to conduct more pragmatic trials. The report provides a list of requirements for conducting pragmatic trials, which are characterized by large sample sizes, simplified operational approaches, fewer restrictions on the use of concomitant therapies, and leveraging of “electronic health record (EHR) and observational data already collected in routine clinical practice or within ongoing observational registries to eliminate redundant data collection.”

Also discussed is the burgeoning successes of the Patient-Centered Outcomes Research Institute’s National Patient-Centered Clinical Research Network, which is working to create a national research infrastructure that engages patients, clinicians and health systems. It also leverages EHRs, administrative claims data and data directly from patients to more efficiently conduct high-quality clinical research.

Medical device trials, while quite different from medicine trials, come up against many of the same burdens, according to the second paper. The paper, led by David R. Holmes Jr, MD, MACC; Robert Califf, MD, MACC, et al., looked at overcoming the challenges of conducting Early Feasibility Studies (EFS) of medical devices in the U.S.

They explain that complex regulations and processes from the U.S. Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH) have contributed to the flight of device trials out of the U.S. “In 2004, 87 percent of clinical studies for medical technology products listed on ClinicalTrials.gov were conducted in the U.S., whereas by 2009, that number dropped to 45 percent.”

To help mitigate the effects of the unique regulatory challenges associated with early device clinical studies, FDA CDRH introduced the EFS Program with the aim of streamlining the system and expediting access to new medical device technology. But to successfully implement the EFS program, the authors note that a more holistic approach is needed.

They recommend the development of a new paradigm that will “require compromise and commitment by a consortium of all stakeholders to view EFS projects differently, accepting that changes to current clinical practice may be needed to fulfill the essential goal of providing the best available, safe, and effective technology to U.S. patients earlier than previously possible.”

They conclude with eight actions that stakeholder groups can take to improve the EFS process, affirming that “improving early access to potentially beneficial medical devices is a shared interest of all participants in the clinical studies ecosystem.” 

Keywords: Academies and Institutes, Benchmarking, Biomedical Research, Cardiovascular Diseases, Data Collection, Electronic Health Records, Ethics Committees, Research, Feasibility Studies, Medicine, Patient Outcome Assessment, Radiologic Health, Randomized Controlled Trials as Topic, Registries, United States Food and Drug Administration

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