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

被引:17
作者
Bagatin, Edileia [1 ]
Miot, Helio A. [2 ]
机构
[1] Univ Fed Sao Paulo UNIFESP, Sao Paulo, Brazil
[2] Univ Estadual Paulista Julio de Mesquita Filho UN, Dept Dermatol & Radiotherapy, Botucatu, SP, Brazil
关键词
Clinical protocols; Clinical trial; Comparative study; Cosmetics; Epidemiologic research design; Research design; RANDOMIZED CONTROLLED-TRIALS; ORAL ISOTRETINOIN; OF-INTEREST; SIZE; IMPACT;
D O I
10.1590/S0365-05962013000100008
中图分类号
R75 [皮肤病学与性病学];
学科分类号
100206 ;
摘要
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.
引用
收藏
页码:69 / 75
页数:7
相关论文
共 34 条
  • [21] Oral isotretinoin as part of the treatment of cutaneous aging
    Hernandez-Perez, E
    Khawaja, HA
    Alvarez, TYM
    [J]. DERMATOLOGIC SURGERY, 2000, 26 (07) : 649 - 652
  • [22] Hulley S.B., 2001, Designing clinical research, V2nd, DOI DOI 10.1016/j.neuroimage.2007.12.053
  • [23] Katz MH, 2006, MULTIVARIABLE ANALYSIS: A PRACTICAL GUIDE FOR CLINICIANS, 2ND EDITION, P1, DOI 10.1017/CBO9780511811692
  • [24] Miot HA, 2011, J VASC BRAS, V10, P276
  • [25] Study Designs in Clinical Research
    Noordzij, Marlies
    Dekker, Friedo W.
    Zoccali, Carmine
    Jager, Kitty J.
    [J]. NEPHRON CLINICAL PRACTICE, 2009, 113 (03): : C218 - C221
  • [26] Extent and impact of industry sponsorship conflicts of interest in dermatology research
    Perlis, CS
    Harwood, M
    Perlis, RH
    [J]. JOURNAL OF THE AMERICAN ACADEMY OF DERMATOLOGY, 2005, 52 (06) : 967 - 971
  • [27] Portal.anvisa.gov, PROT SAUD MED ASS IN
  • [28] Methods and design considerations for randomized clinical trials evaluating surgical or endovascular treatments for cerebrovascular diseases
    Qureshi, AI
    Hutson, AD
    Harbaugh, RE
    Stieg, PE
    Hopkins, LN
    [J]. NEUROSURGERY, 2004, 54 (02) : 248 - 264
  • [29] The nature of clinical evidence: Floating currencies rather than gold standards
    Rees, Jonathan
    [J]. JOURNAL OF INVESTIGATIVE DERMATOLOGY, 2007, 127 (03) : 499 - 500
  • [30] Research fundamentals: III. Elements of a research protocol for clinical trials
    Silverman, R
    Kwiatkowski, T
    [J]. ACADEMIC EMERGENCY MEDICINE, 1998, 5 (12) : 1218 - 1223