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European Heart Journal: Randomized Controlled Trials are not always the solution

European Heart Journal Article | Published 13 December 2023

By Sara Finocchietti (NAMSA Senior Strategy Consultant, Clinical)

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




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Monica Tantalean

Monica Tantalean, BS, AAS, CVT currently serves as one of NAMSA's Global Marketing Specialists and joined the organization with the acquisition of American Preclinical Services (APS) in 2021. She has been with APS since 2017. Monica has 7 years' experience within the medical device and veterinary healthcare industries and has worked in a variety of roles from Surgical Technician to Business Development. In her role at NAMSA, she is responsible for assisting with the development and execution of marketing communications that contribute to organizational growth and sales.