Tip of the Week Archive

The International Committee of Medical Journal Editors (ICMJE) policy compels its member journals to require that clinical trials be registered on ClinicalTrials.gov before enrollment of the first participant as a condition of consideration for publication.

ICMJE 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, behavioural 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.

Additionally, ICMJEexpects authors to ensure that they have met funder policy (e.g., NIH) and regulatory requirements for results reporting. ICMJE recommends referencing the ClinicalTrials.gov record in publications, and therefore journals often carefully verify whether the results data submitted to ClinicalTrials.gov aligns with the manuscript, particularly in regards to outcome measure data. In some cases, journals have declined to publish a manuscript, or have asked that discussions of certain outcome measures be removed from the manuscript, due to discrepancies between the results reported to ClinicalTrials.gov and the manuscript.

Avoiding heartache when it's time to publish is easy! Simply:

1. register any interventional health-related research in humans prior to enrollment (err on the side of caution, if unsure), and
2. be sure to post accurate results data, if required, within 12 months of the Primary Completion Date (usually, the last participant's last study visit).

For help registering your study or submitting results to ClinicalTrials.gov, contact clinicalresearchsupportcenter@ucdenver.edu.