Human Reproduction, Vol. 18, No. 5, 1005-1009,
May 2003
© 2003 European Society of Human Reproduction and Embryology
Pitfalls in the design and analysis of efficacy trials in subfertility
Associate editor’s commentary: on the article ‘Common statistical errors in the design and analysis of subfertility trials’ by A.Vail and E.Gardner.
Departments of Obstetrics and Gynecology, and Clinical Epidemiology and Biostatistics, McMaster University, Hamilton, Ontario, Canada
1 To whom correspondence should be addressed at: McMaster University, 1200 Main Street West, Hamilton, Ontario, Canada, L8N 3Z5. e-mail: dayas@mcmaster.ca
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Introduction |
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The introduction, more than half a century ago, of the randomized trial in which allocation to the experimental and control interventions occurs by chance has been a pivotal point in the evaluation of therapeutic efficacy. It is now well accepted that the gold standard in such evaluation is the well-designed controlled, clinical experiment that has high methodological rigour so that bias can be minimized and the magnitude of treatment effect can be estimated reliably and confidently. The acceptance of the randomized controlled trial (RCT) in the field of reproductive medicine is evident by the increasing numbers of such trials being published.
In the mid-1990’s the importance of improving the quality of reports of RCTs led to the publication of the Consolidated Standards of Reporting Trials (CONSORT) statement (1996) which was developed by an international group of experts, comprising clinical trialists, statisticians, epidemiologists and biomedical editors. The CONSORT statement, which consists
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What steps can be taken to reduce such errors so that the results of the trials can be interpreted reliably? |
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(i) Intention-to-treat analysis
(ii) Concealment of allocation
(iii) Cross-over trial
(iv) First cycle enrolment
(v) Sample size estimation
(vi) Lack of superiority versus equivalence
(vii) Definition of pregnancy and the implantation rate
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Summary |
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