Guideline for authors

CLINICAL TRIAL REGISTRATION My trial was finished a long time ago. Do I still need to register? If the results of your trial have been previously published and this is a follow-up or secondary publication, then no. Otherwise, yes. If you saw the last patient before September 13, 2005, please register your study before submission and make a note in your cover letter. I didn’t know I needed to register my trial. The last patient intervention occurred after September 13, 2005. Will you still consider our trial? The NEJM policy is firm. If the trial was ongoing or started after September 13, 2005, it MUST have been registered in a WHO/ICMJE compatible database (of which there were at least four functional worldwide) as of December 31, 2005, if there was commercial sponsorship or by December 31, 2006, if there was no commercial sponsorship. If you have not met these requirements, we cannot consider your trial for review. Does this also apply to pilot trials? No. Only pilot (phase I) trials that began on or after July 1, 2008, need to be registered before first patient enrollment. Is EUDRACT an acceptable registry? What about Center Watch? Where can I find a list of ICMJE-approved registries? We will accept registration in the European Clinical Trials Database if the trial began on or after July 13, 2011, and if it was registered before the first patient was enrolled. We will not consider trials that were registered prior to that date; however we will consider trials that are registered in an ICMJE/WHO compatible database. Click here to view a list of ICMJE-acceptable registries. ICMJE maintains a list of acceptable registries in the FAQ section of its website. Additionally, the ICMJE will accept registration in any of the PRIMARY registries that participate in the WHO International Clinical Trials Registry Platform (ICTRP). 
 * NEJM