Trial Registration. As a member of the International Committee of Medical Journal Editors (ICMJE), Archives of Pediatrics & Adolescent Medicine will require, as a condition of consideration for publication, registration of all trials in a public trials registry.8,15 Trials must be registered at or before the onset of patient enrollment. This policy applies to any clinical trial starting enrollment after July 1, 2005. For trials that began enrollment before this date, registration will be required by September 1, 2005, before considering the trial for publication. For this purpose, the ICMJE defines a clinical trial as any research project that prospectively assigns human subjects to intervention or comparison groups to study the cause-and-effect relationship between a medical intervention and a health outcome. Studies designed for other purposes, such as to study pharmacokinetics or major toxicity (eg, phase I trials), are exempt.