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Evidence-Based Medicine and Good Clinical Practice in Research in Pediatric and Adolescent Medicine
Ageliki A Karatza1, Asimina Tsintoni1, Dimitrios Kapnisis1
1Department of Pediatrics, University of Patras Medical School, 26504 Patras, Greece.
Abstract:
Practicing medical research based on the best evidence is gaining increased value and popularity among most medical societies in the current era. Good clinical practice (GCP) is internationally recognized as the scientific and ethical standard for the design, conduct, performance, auditing, recording, analysis, and reporting of clinical trials involving human subjects. GCP ensures the accuracy and credibility of trial while safeguarding the rights, integrity, and confidentiality of participants. Adherence to GCP facilitates the generation of high-quality studies that can be incorporated in Evidence-Based Medicine (EBM). The clinical practice of EBM seeks to integrate robust medical literature into daily medical practice. This process involves systematically searching for high-quality evidence, critically appraising the retrieved literature, applying sound clinical principles and finally evaluating the efficacy of the chosen approach. Although EBM has been evaluated in many resource settings, it has not been addressed sufficiently in the field of Pediatrics and more specifically in indigenous populations. In this review, we briefly explain the EBM approach and its applications in Pediatrics, in order to help physicians care for young subjects more efficiently by integrating the best available information into their routine clinical practice. Also, the basic good practice principles for conducting clinical trials in children and adolescents are highlighted, emphasizing the importance of applying high ethical principles in this vulnerable population.
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