European Heart Journal: Randomized Controlled Trials Are Not Always the Solution

Operating room with monitor

Published:

December 13, 2023

Author Info:

Sara Finocchietti, MEng, PhD

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European Heart Journal Article | Published 13 December 2023

The recent article authored by Siontis et al.1 has made considerable contributions to the ongoing debate concerning the pre-market clinical evaluation of implantable medical devices in Europe, with a particular focus on the cardiovascular domain.

The study encompassed seven different classes of devices over a span of 20 years, providing comprehensive details regarding study design, patient demographics, interventions, and primary outcomes. This information was critically evaluated in relation to the timing of the corresponding CE-mark approval, offering valuable insights that can shape the design of clinical investigations for novel devices.

However, it is important to acknowledge certain reservations about the conclusions drawn in the article:

Firstly, a randomized controlled trial (RCT) design is not always a feasible or ethical option. While RCTs remain a cornerstone of evidence-based medicine, they may present practical and ethical challenges in the context of medical device evaluations, especially in the case of vulnerable populations like children.2 As an alternative, prospective cohort studies and adaptive design trials have gained prominence due to their capacity to enhance result generalizability and explore individual variations and causal mechanisms.3,4

Sara Finocchietti, MEng, PhD

Sara Finocchietti, MEng, PhD

Sara Finocchietti has 15 years of experience in the medical device industry, having lived in multiple European countries and Japan. Her career started in public research developing innovative medical devices as well as providing clinical and regulatory strategy for market access in Europe. Her previous experiences include working as a Clinical Affairs Manager at a French manufacturer with a full orthopedic portfolio, defining the strategy to transition to the EU's Medical Device Regulation (MDR). Sara has a keen interest in new technologies and innovation. She has extensive experience working within cross-functional and cross-cultural teams.

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