Characteristics of pivotal clinical trials of FDA-approved endovascular devices between 2000 and 2018: An interrupted time series analysis

John T Moon; Menelaos Konstantinidis; Nevon Song; Nariman Nezami; Bill S Majdalany; Allen Herr; Gary Siskin

doi:10.1017/cts.2023.10

Characteristics of pivotal clinical trials of FDA-approved endovascular devices between 2000 and 2018: An interrupted time series analysis

J Clin Transl Sci. 2023 Feb 3;7(1):e67. doi: 10.1017/cts.2023.10. eCollection 2023.

Authors

John T Moon¹, Menelaos Konstantinidis², Nevon Song³, Nariman Nezami⁴, Bill S Majdalany¹, Allen Herr³, Gary Siskin³

Affiliations

¹ Division of Interventional Radiology and Image-Guided Medicine, Department of Radiology and Imaging Sciences, Emory University School of Medicine, Atlanta, GA, USA.
² Division of Biostatistics, Institute of Health Policy, Management and Evaluation, University of Toronto, Toronto, Ontario, Canada.
³ Albany Medical College, Albany, NY, USA.
⁴ Division of Vascular and Interventional Radiology, Department of Diagnostic Radiology and Nuclear Medicine, University of Maryland School of Medicine, Baltimore, MD, USA.

Abstract

Background: The Food and Drug Administration (FDA) reviews safety, efficacy, and the quality of medical devices through its regulatory process. The FDA Safety and Innovation Act (FDASIA) of 2012 was aimed at accelerating the regulatory process for medical devices.

Objectives: The purpose of our study was to (1) quantify characteristics of pivotal clinical trials (PCTs) supporting the premarket approval of endovascular medical devices and (2) analyze trends over the last two decades in light of the FDASIA.

Methods: We surveyed the study designs of endovascular devices with PCTs from the US FDA pre-market approval medical devices database. The effect of FDASIA on key design parameters (e.g., randomization, masking, and number of enrolled patients) was estimated using an interrupted time series analysis (segmented regression).

Results: We identified 117 devices between 2000-2018. FDASIA was associated with a decrease in double blinding (p < 0.0001) and a decrease in historical comparators (p < 0.0001).

Discussion: Our results reveal an overall trend of decreased regulatory requirements as it relates to clinical trial characteristics, but a compensatory increased rate of post-approval across device classes. Furthermore, there was an emphasis on proving equivalence or non-inferiority rather than more use of active comparators in clinical trials. Medical device stakeholders, notably clinicians, must be aware of the shifting regulatory landscape in order to play an active role in promoting patient safety.

Keywords: Food and Drug Administration; Regulatory approval; medical devices; policy.