RANDOMIZED CONTROLLED CLINICAL TRIALS: CONCEPTUAL FOUNDATIONS AND SCIENTIFIC-METHODOLOGICAL APPROACHES TO EVIDENCE TRANSLATION INTO CLINICAL PRACTICE
DOI:
https://doi.org/10.32782/pub.health.2026.1.23Keywords:
evidence-based medicine, randomised controlled clinical trials, clinician, effectiveness indicators, clinical question, PICO, algorithm, international evidence-based medicine resources, evidence implementation, clinical practiceAbstract
Topicality. Evidence-based medicine, grounded in the findings of randomised controlled clinical trials as the “gold standard”, necessitates a thorough understanding among physicians not only of its theoretical foundations for the interpretation of evidence, but also of the scientific and methodological approaches required for the translation and implementation of research findings into clinical practice.
Aim of the study – to provide a theoretical substantiation of the conceptual foundations of randomised clinical trials as the “gold standard” of evidence-based medicine and to synthesise scientific and methodological approaches to the implementation of their findings into physicians’ clinical practice in the context of the ongoing transformation of the healthcare system in Ukraine.
Materials and methods. A cross-sectional, descriptive, comprehensive theoretical and applied study was conducted to achieve the aim and objectives of the research. The study materials included contemporary scientific publications, reviews, methodological guidelines, and research studies (2019–2024) addressing the design and outcomes of randomised controlled trials, as well as approaches to their integration into clinical practice and managerial decision-making.
The methodological framework was based on systems analysis, comparative analysis, synthesis and generalisation, structural-logical and system-structural analysis, as well as a deductive approach combined with content analysis grounded in the principles of systems thinking, in accordance with the field of knowledge “I Healthcare and Social Welfare”.
Research results. The synthesis of scientific sources confirmed that randomised clinical trials represent the “gold standard” of evidence-based medicine, as they provide the highest level of reliability in assessing the effectiveness and safety of medical interventions and form the basis of clinical guidelines. It was established that the use of the PICO framework for formulating clinical questions improves the clarity in defining the patient, intervention, comparison, and outcome, thereby optimising subsequent evidence search and appraisal. It was demonstrated that the application of standardised search algorithms in electronic databases ensures the selection of high-quality studies, increases the accuracy of findings, and reduces the influence of subjectivity. It was further emphasised that the implementation of evidence into clinical practice is a key determinant of improving the quality of healthcare delivery and standardising diagnostic and therapeutic decision-making.
Conclusions. Evidence-based medicine serves as a key methodological foundation of contemporary clinical practice, integrating findings from the highest levels of evidence with clinicians’ expertise and patients’ individual characteristics, thereby ensuring the optimisation of diagnostic and therapeutic strategies and improving the effectiveness of secondary disease prevention. It has been demonstrated that the implementation of an algorithm-based approach to searching, critically appraising, and synthesising scientific evidence in clinical practice contributes to improved quality of medical decision-making, as well as its scientific validity, reproducibility, and standardisation.
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