The importance of clinical trial protocols
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Abstract
The International Committee of Medical Journal Editors (ICMJE) and the World Health Organization (WHO) define a clinical trial as any research that prospectively assigns participants or groups of human subjects to one or more interventions (medicines, procedures, devices, behavioral treatments, dietary supplements and diets, for example). These trials aim to evaluate the effects of interventions on human health. Prospective clinical research is essential for discovering new knowledge, improving the scientific base, solving challenges, and improving clinical practices. The basic principles for a successful researcher include interest, availability, persistence, and honesty. However, it is essential that, first of all, one has complete and detailed knowledge of scientific writing and preparation of the research protocol.
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References
Angelis CD, Drazen JM, Frizelle FA, Haug C, Hoey J, Horton R, et al. Clinical trial registration: a statement from the International Committee of Medical Journal Editors. Lancet. 2004;364(9438):911-2. http://doi.org/10.1016/S0140- 6736(04)17034-7. PMid:15364170. DOI: https://doi.org/10.1016/S0140-6736(04)17034-7
Bagatin E, Miot HA. How to design and write a clini¬cal research protocol in Cosmetic Dermatology. An Bras Dermatol. 2012;88(1):69-75. https://doi.org/10.1590/S0365- 05962013000100008. PMid:23539006. DOI: https://doi.org/10.1590/S0365-05962013000100008
Schulz KF, Altman DG, Moher D, CONSORT Group. CONSORT 2010 Statement: updated guidelines for reporting parallel group randomised trials. BMC Med. 2010;8(1):18. http://doi. org/10.1186/1741-7015-8-18. PMid:20334633. DOI: https://doi.org/10.1186/1741-7015-8-18
Chan AW, Tetzlaff JM, Altman DG, Laupacis A, Gøtzsche PC, Krleža- Jerić K, et al. SPIRIT 2013 statement: defining standard protocol items for clinical trials. Ann Intern Med. 2013;158(3):200-7. http://doi.org/10.7326/0003-4819-158-3-201302050-00583. PMid:23295957. DOI: https://doi.org/10.7326/0003-4819-158-3-201302050-00583
ReBEC: Registro Brasileiro de Ensaios Clínicos. 2024 [cited 2024 June 5]. Available from: https://ensaiosclinicos.gov.br