Irreproducible results The role of sample size blinding and interim analysis

In two reviews previously published in this journal on study design and clinical trials registration, we emphasized the importance of doing a calculation of the sample size required to examine the primary outcome of a trial.

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Authors

David Meldrum, M.D.

Volume 102, Issue 3, Pages 656-657

Abstract

In two reviews previously published in this journal on study design and clinical trials registration, we emphasized the importance of doing a calculation of the sample size required to examine the primary outcome of a trial (1, 2). Then the data must not be analyzed until that number of subjects is reached. If interim analysis or analyses are carried out it is necessary to alter the level of statistical significance required to reject the null hypothesis (3). Unfortunately, the clinicaltrials.gov website does not specifically require recording of a sample size calculation, but rather requires that the investigators record a “target or actual number of patients,” assumed to be equal to the sample size plus enough additional enrolled subjects to make up for expected drop-outs.

Read the full text at: http://www.fertstert.org/article/S0015-0282(14)01395-8/fulltext


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Fertility and Sterility

Editorial Office, American Society for Reproductive Medicine

Fertility and Sterility® is an international journal for obstetricians, gynecologists, reproductive endocrinologists, urologists, basic scientists and others who treat and investigate problems of infertility and human reproductive disorders. The journal publishes juried original scientific articles in clinical and laboratory research relevant to reproductive endocrinology, urology, andrology, physiology, immunology, genetics, contraception, and menopause. Fertility and Sterility® encourages and supports meaningful basic and clinical research, and facilitates and promotes excellence in professional education, in the field of reproductive medicine.

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