Modern approaches to the development of a theoretical platform for clinical trials of medical devices for in vitro diagnostics

Solonin S.A.; Godkov M.A.

doi:https://doi.org/10.17116/labs20241301148

Solonin S.A.

Sklifosovsky Research Institute for Emergency Medicine

ORCID: 0000-0002-4379-6243

Godkov M.A.

Sklifosovsky Research Institute for Emergency Medicine;
Russian Medical Academy for Continuous Professional Education

RSCI AuthorID: 750164
Scopus AuthorID: 24576635800
ORCID: 0000-0001-9612-6705

Modern approaches to the development of a theoretical platform for clinical trials of medical devices for in vitro diagnostics

Authors:

Solonin S.A., Godkov M.A.

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Journal: Laboratory Service. 2024;13(1): 48‑59

DOI: 10.17116/labs20241301148

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To cite this article:

Solonin SA, Godkov MA. Modern approaches to the development of a theoretical platform for clinical trials of medical devices for in vitro diagnostics. Laboratory Service. 2024;13(1):48‑59. (In Russ.)
https://doi.org/10.17116/labs20241301148

Подписка 2025 Лабораторная служба (Laboratory Service)

Использование инфографики авторами научных работ

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INTRODUCTION

The rapid development of clinical laboratory diagnostics has naturally led to the complication of the process of clinical trials of medical devices for in vitro diagnostics (MD IVD), in particular the trials conducted for the purposes of state registration. The need for a wide use of scientific approaches within this type of activity is becoming more and more obvious. However, at present a unified view of the scientific problems of MD IVD testing has not been formed, and this makes it necessary to systematize and generalize the accumulated knowledge and experience in order to provide maximal reliability of the procedure which guarantees circulation of high-quality medical products on the national market.

OBJECTIVE

To substantiate the theory and practice of clinical trials of MD IVD as an applied research work.

MATERIAL AND METHODS

Analysis of the current state of clinical trials of MD IVD taking into account our own experience and global trends in the field of research of performance characteristics, clinical efficacy and safety of this group of medical devices was carried out.

RESULTS

Clinical trials of MD IVDs have become an independent interdisciplinary scientific branch which develops at the intersection of several types of activities: medical (evaluation of efficacy and safety of use), legal (legal regulation issues), and economic (material and financial resources) ones. Clinical trials are based on their own paradigm and methodology, which in many aspects are regulated by regulatory legal acts. This dynamically upcoming field of science faces a number of objective problems: insufficient harmonization at the intra- and interstate level, shortage of qualified tester specialists, mismatch between the legal framework and technological advances.

CONCLUSIONS

The relevance of the development of the theoretical basis for conducting clinical trials of MD IVD is substantiated. The main scientific problems that arise during the implementation of this form of conformity assessment are indicated, and the ways of their solution are outlined. The significance of comprehensive development of the new scientific direction is shown.

Keywords:

in vitro diagnostic medical devices

performance evaluation of in vitro diagnostic medical devices

clinical laboratory trials

medical science

clinical laboratory diagnostics

clinical diagnostic laboratory

registration of medical devices

Authors:

Solonin S.A.

Sklifosovsky Research Institute for Emergency Medicine

ORCID: 0000-0002-4379-6243

Godkov M.A.

Sklifosovsky Research Institute for Emergency Medicine;
Russian Medical Academy for Continuous Professional Education

RSCI AuthorID: 750164
Scopus AuthorID: 24576635800
ORCID: 0000-0001-9612-6705

Received:

22.11.2023

Accepted:

22.01.2024

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References:

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