ICMJE statement on compulsory clinical trial registration: should Indian journals follow suit?

In May 2005, the International Council for Medical Journal Editors (ICMJE), a group of general medical journal editors who have been responsible for introducing the “uniform requirements for manuscripts submitted to biomedical journals”, released a joint editorial statement on registration of clinical trials. ICMJE journals will consider manuscripts reporting clinical trials only if the trial was registered in a public registry before patient recruitment started. Trials which started before the ICMJE statement are given a grace period within which they must be registered. This is an update of the ICMJE statement published a few months earlier. The statements are a first step to regulate and make transparent the messy and murky world of clinical trials. The ICMJE seeks to create an accessible and searchable public record of all clinical trials, containing all the relevant information clinicians need to make informed decisions regarding a particular treatment option, not just what “the researchers wanted to report and the editors chose to publish”. The ICMJE has clarified that registration is required of all “clinically directive trials” phase 3 trials that test a health outcome, whether drug, surgical procedure, behavioural therapy or screening procedure. In short, any study where an intervention is compared with a concurrent control group. Among exempt trials are the purely pharmacokinetic studies or phase 1 clinical trials. However, the ICMJE urges researchers, when in doubt, to go ahead and register. The ICMJE statement was signed by editors representing major international medical journals with the exception of the BMJ which supported the idea but differed on the type of trial registry. 4] The idea of registering clinical trials, mooted nearly three decades ago, has long been resisted. The example of paroxetine illustrated the importance of early registration and transparency in clinical trials. Certain safety and efficacy data of paroxetine in major depressive disorders in children and young adults had been withheld from publication. As a result, thousands of patients were prescribed the drug unnecessarily. This is just one example of a widespread problem.