Como desenhar e escrever um protocolo de pesquisa clínica em Cosmiatria


Autoria(s): Bagatin, Ediléia; Miot, Hélio Amante
Contribuinte(s)

Universidade Estadual Paulista (UNESP)

Data(s)

27/05/2014

27/05/2014

01/01/2013

Resumo

Cosmetic Dermatology is a growing subspecialty. High-quality basic science studies have been published; however, few double-blind, randomized controlled clinical trials, which are the major instrument for evidence-based medicine, have been conducted in this area. Clinical research is essential for the discovery of new knowledge, improvement of scientific basis, resolution of challenges, and good clinical practice. Some basic principles for a successful researcher include interest, availability, persistence, and honesty. It is essential to learn how to write a protocol research and to know the international and national regulatory rules. A complete clinical trial protocol should include question, background, objectives, methodology (design, variable description, sample size, randomization, inclusion and exclusion criteria, intervention, efficacy and safety measures, and statistical analysis), consent form, clinical research form, and references. Institutional ethical review board approval and financial support disclosure are necessary. Publication of positive or negative results should be an authors' commitment. © 2013 by Anais Brasileiros de Dermatologia.

Formato

69-75

Identificador

http://dx.doi.org/10.1590/S0365-05962013000100008

Anais Brasileiros de Dermatologia, v. 88, n. 1, p. 69-75, 2013.

0365-0596

1806-4841

http://hdl.handle.net/11449/74261

10.1590/S0365-05962013000100008

S0365-05962013000100008

WOS:000316807000008

2-s2.0-84875400305

2-s2.0-84875400305.pdf

Idioma(s)

eng

por

Relação

Anais Brasileiros de Dermatologia

Direitos

openAccess

Palavras-Chave #Clinical protocols #Clinical trial #Comparative study #Cosmetics #Epidemiologic research design #Research design #cosmetic #isotretinoin #placebo #sunscreen #actinic keratosis #clinical practice #clinical protocol #clinical research #comparative study #cryotherapy #dermatology #drug efficacy #drug safety #elasticity #evidence based medicine #human #humidifier #hydration #methodology #mucocutaneous candidiasis #photoaging #randomized controlled trial (topic) #review #skin surface
Tipo

info:eu-repo/semantics/article