Clinical Trial Registration

In September 2004 the International Committee of Medical Journal Editors (ICJME) published an editorial in which it stated:

• The ICMJE member journals will require, as a condition of consideration for publication, registration in a public trials registry. Trials must register at or before the onset of patient enrolment. This policy applies to any clinical trial starting enrolment after July 1, 2005. For trials that began enrolment prior to this date, the ICMJE member journals will require registration by September 13, 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. Ann Intern Med. 2004;141:477-478.

In the UK there has been no mandatory requirement for trial registration; unfortunately this has led to some studies experiencing difficulty publishing in the most prestigious journals on completion. We would therefore recommend all clinical trials including non-IMP trials be included in a recognised clinical trials register.

The preferred option is using the International Standard Randomised Controlled Trial Number (ISRCTN) and a process has been developed which allows free ISRCTN registration for non-commercial studies on the NIHR portfolio.

An alternative to ISRCTN registration is ClinicalTrials.gov which is an American based site that registers studies free of charge.