Tip of the Week Archive

ICMJE policy states that, in order to be eligible for publication in member journals, clinical trials must be registered on ClinicalTrials.gov PRIOR to the enrollment of the first subject. 

The International Committee of Medical Journal Editors defines a clinical trial as “any research project that prospectively assigns people or a group of people to an intervention, with or without concurrent comparison or control groups, to study the relationship between a health-related intervention and a health outcome.

• Health-related interventions are those used to modify a biomedical or health-related outcome; examples include drugs, surgical procedures, devices, behavioral treatments, educational programs, dietary interventions, quality improvement interventions, and process-of-care changes.

   

• Health outcomes are any biomedical or health-related measures obtained in patients or participants, including pharmacokinetic measures and adverse events.

   

• This definition doesn’t include observational trials, though some journals may request that you retrospectively register an observational study prior to publication of the manuscript.

Trial registration is no joke, but Clinical Research Support is here to help! Contact clinicalresearchsupportcenter@ucdenver.edu at any time for assistance, or visit our ClinicalTrials.gov support page.