Ensaios Clínicos em Medicamentos
Abstract
Randomized controlled trial, despite some disadvantages, is usually considered the gold standard for determining the efficacy of an intervention (drugs, clinical devices, surgery, etc.). In this article, we discuss some aspects of the trial design needed for its critical appraisal of quality.
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References
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Carneiro AV. Estimating sample size in clinical studies: basic methodological principles. Rev Port Cardiol 2003; 12: 1513-21
Roque A, Carneiro AV. Types of clinical studies – IV Clinical trials. Rev Port Cardiol 2005; 12:1535-56
Soares I, Carneiro AV. Basics of methodologic analysis of therapeutic trials. Part I: Validity of the results. Rev Port Cardiol 2002; 4: 455-65
Fernandes SM, Carneiro AV. Types of clinical studies – II Cohort studies. Rev Port Cardiol 2005; 5: 1151-5
Vaz D, Santos L, Machado M, Carneiro AV. Randomization methods in clinical trials. Rev Port Cardiol 2004; 5: 541-55
McLeod R. Randomized, controlled trials: is there a role for them in surgery? Ann Surg 2006; 5:654-5
Ergina PL, Cook JA, Blazeby J, Boutron I, Clavien PA, Reeves B and Seiler C. Challenges In Evaluating Surgical Innovation. The Lancet 2005; 354: 1055-1104
Berger RL, Celli BR, Meneghetti AL, Bagley PH, Wright CD, Ingenito EP, Gray A, Snider GL. Limitations of randomized clinical trials for evaluating emerging operations: the case of lung volume reduction surgery. Ann Thorac Surg 2001; 2: 645-55 5. Carneiro AV. Bias in clinical studies. Rev Port Cardiol 2011; 2: 235-42
Moher D, Hopewell S, Schulz F, et al. CONSORT 2010 Explanation and Elaboration: updated guidelines for reporting parallel group randomized trials. BMJ 2010; 340: c565
Vaz Carneiro A. [Evaluation of Clinical Research]. J Port Gastrenterol 2005; 15:30-36
Hansen JB, Smithers BM, Dchache D, Wall DR et al. Laparoscopic versus open appendectomy: a prospective randomized trial. World J Surg 1566; 20: 15-20
Carneiro AV. Estimating sample size in clinical studies: basic methodological principles. Rev Port Cardiol 2003; 12: 1513-21
Published
2013-03-18
How to Cite
BORGES, Margarida.
Ensaios Clínicos em Medicamentos.
Revista Portuguesa de Cirurgia, [S.l.], n. 24, p. 57-63, mar. 2013.
ISSN 2183-1165.
Available at: <https://revista.spcir.com/index.php/spcir/article/view/15>. Date accessed: 25 apr. 2024.
Section
SPECIAL FILE – RESEARCH IN SURGERY
