Are there any ICMJE registration requirements for clinical trial study?
The International Committee of Medical Journal Editors (ICMJE) now require that clinical trials are registered at the start. Trials that are not registered at onset will not be considered for publication. Note that ICMJE represents the major health science journals worldwide so registration is essential to ensure eligibility for publication. ICMJE requires registration for all clinical trials as defined by “Any research project that prospectively assigns human subjects to intervention and comparison groups to study the cause-and-effect relationship between the medical intervention and the health outcome”. Medical intervention is to be interpreted broadly to include drugs, devices, surgical procedures, behavioural or management studies which have the intent to modify a health outcome. In general all Phase III studies will need to be registered. However Phase I and some phase II studies are excluded. The Principal Investigator of a clinical trial is responsible for registering the trial
