Clinical validation as a mechanism for transforming the implementation of innovative medical technologies: ten years of experience at the national medical research center (2015–2025).

Résumé fourni par la source

Clinical approbation of innovative medical technologies in pediatric oncology, hematology and immunology is of particular importance due to the high proportion of orphan diseases and the need for high-tech interdisciplinary approaches. At the same time, the issues of practical translation of clinical approbation results into clinical guidelines, regulatory documents and financing mechanisms remain insufficiently studied. Purpose of the study is to characterize the portfolio of clinical approbation protocols, assess their distribution across the stages of the medical technologies life cycle, and identify the main mechanisms for translating the obtained results into practical healthcare. Materials and methods. A retrospective descriptive analysis of 46 clinical approbation protocols initiated, supported, or completed at the Dmitry Rogachev National Medical Research Center of Pediatric Hematology, Oncology and Immunology of the Ministry of Health of Russia in the period 2015–2025 was conducted. The protocol portfolio covered drug and combined treatment methods, hematopoietic stem cell transplantation, cell technologies, surgical treatment of complex tumors, reconstructive interventions, diagnostic and monitoring approaches, as well as medical rehabilitation technologies. For each protocol, the stage of the life cycle (completed cycle, active implementation and administrative support, methodological revision and feasibility assessment) was determined, as well as the presence of subsequent translation of results into healthcare system documents. Results. Among the 46 protocols analyzed, 22 (48%) successfully concluded their full implementation cycle, culminating in the submission of a final report. Concurrently, 6 protocols (13%) were undergoing execution, initiation, or administrative oversight, whereas 18 (39%) necessitated methodological refinement or a re-evaluation of their feasibility. The insights gained from this clinical evaluation were subsequently institutionalized within the healthcare system. Specifically, they were integrated into clinical guidelines, healthcare delivery protocols, medical reimbursement models, educational textbooks, methodological manuals, and the Center’s internal organizational frameworks. Findings. Clinical approbation in a federal center performs evaluative, methodological, organizational, economic, and translational functions. The most significant result is not only the implementation of individual protocols, but also the formation of a sustainable mechanism for the transition of medical technology from a clinical idea to regulatory, methodological, and financial consolidation in the healthcare system.

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