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

Abstract

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.

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