How to design and write a clinical research protocol in Cosmetic Dermatology

How to design and write a clinical research protocol in Cosmetic Dermatology

Alternative title How to design and write a clinical research protocol in Cosmetic Dermatology
Author Bagatin, Edileia Autor UNIFESP Google Scholar
Miot, Helio Amante Autor UNIFESP Google Scholar
Institution Universidade Federal de São Paulo (UNIFESP)
Universidade de São Paulo (USP)
Abstract 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.
Keywords Clinical protocols
Clinical trial
Comparative study
Cosmetics
Epidemiologic research design
Research design
Language English
Date 2013-01-01
Published in Anais Brasileiros De Dermatologia. Rio De Janeiro Rj: Soc Brasileira Dermatologia, v. 88, n. 1, p. 69-75, 2013.
ISSN 0365-0596 (Sherpa/Romeo, impact factor)
Publisher Soc Brasileira Dermatologia
Extent 69-75
Origin http://dx.doi.org/10.1590/S0365-05962013000100008
Access rights Open access Open Access
Type Review
Web of Science ID WOS:000316807000008
SciELO ID S0365-05962013000100008 (statistics in SciELO)
URI http://repositorio.unifesp.br/11600/42510

Show full item record




File

File Size Format View

There are no files associated with this item.

This item appears in the following Collection(s)

Search


Browse

Statistics

My Account