Some considerations related to clinical trials
Keywords:
clinical trial, medical ethic.Abstract
Clinical trials are controlled and planned experiments involving human volunteers, used to evaluate the efficacy and safeness of surgical, medical and sanitary interventions, and also to determine the pharmacologic, pharmacokinetics or pharmacodynamic effects of new therapeutic products, including their adverse reactions study. Considered the paradigm of the epidemiologic research, because they are the designs that are more similar to an experiment due to the control of the conditions under study, and because they could establish cause-effect relations, the clinical trials favor
decision-making in public health and, beginning from the moment of the implementation of their results, they contribute to the increase of the life quality of human beings wherever they live. The priority of health care decision-makers should be seeing for their correct design, evaluation and following-up by the scientific councils and research ethic committees, and also for the adequate interpretation of the results and their publication.
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2. Manríquez J, Valdivia G, Rada G, Letelier LM. Análisis crítico de ensayos clínicos randomizados publicados en revistas biomédicas chilenas. Rev Méd Chile. 2005; 133:439- 46.
3. Clyburne-Sherin AV, Thurairajah P, Kapadia MZ, Sampson M, Chan WW, Offringa M. Recommendations and evidence for reporting items in pediatric clinical trial protocols and reports: two systematic reviews. Trials. 2015; 16(1):417.
4. Turner L, Shamseer L, Altman DG, Weeks L, Peters J, Kober T, et al. Consolidated standards of reporting trials (CONSORT) and the completeness of reporting of randomised controlled trials (RCTs) published in medical journals. Cochrane Database Syst Rev. 2012 Nov 14; 11:MR000030.
5. Lazcano-Ponce E, Salazar-Martínez E, Gutiérrez-Castrellón P, Angeles-Llerenas A, Hernández-Garduño A, Viramontes JL. Ensayos clínicos aleatorizados: variantes, métodos de aleatorización, análisis, consideraciones éticas y regulación. Salud Pública de México. 2004; 46(6):559- 84.
6. Kenneth F. Schulz, Douglas G. Altman, David Moher for the CONSORT Group. CONSORT 2010 Statement: Updated Guidelines for Reporting Parallel Group Randomized Trials. Ann Intern Med. 2010; 152(11):1- 8.
7. Barnhill A, Miller FG. The ethics of placebo treatments in clinical practice: a reply to Glackin. J Med Ethics. 2015; 41(8):673- 6.
8. Ćurković M1, Živković M, Radić K, Vilibić M, Ćelić I, Bagarić D. Ethical Overview of Placebo Control in Psychiatric Research - Concepts and Challenges. Psychiatr Danub. 2015; 27(2):118- 25.
9. Cañete R, Guilhem D, Brito K. Consentimiento informado: algunas consideraciones actuales. Acta Bioeth. 2012; 18(1):121- 7.
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