The WHO, WHY, WHAT, WHEN, WHERE, and HOW of clinical trial registries

Abstract

Clinical trials must be appropriately registered prior to patient enrollment to be considered for publication by most top journals, including Fertility and Sterility. Clinical trials involving FDA regulated drugs, whether investigational or already approved, must be registered by law, and summary results must be posted in the registry whether ultimately published or not. This review provides detailed information for authors regarding these requirements and a discussion as to their importance for acceptance of a manuscript and for reviewers to be assured of the integrity of the trial design, execution, and analysis. The accompanying review on study design and statistics is meant to illustrate the difficulties reviewers experience in evaluating a manuscript that does not follow these requirements. The editors of Fertility and Sterility reiterate that clinical trials that have not been registered will not be accepted for review.