Registration of Clinical Trials

Definition of Clinical Trials

Catalyst Research Chronicles adheres to the clinical trial definition established by the International Committee of Medical Journal Editors (ICMJE). A clinical trial is defined as any research study that prospectively assigns individuals or groups to an intervention, with or without concurrent comparison or control groups, to investigate the relationship between a health-related intervention and a health outcome.

Health-related interventions may include drugs, surgical procedures, devices, behavioral treatments, educational programs, dietary interventions, quality improvement initiatives, and changes in processes of care. Health outcomes encompass any biomedical or health-related measures obtained from patients or participants, including pharmacokinetic measurements and adverse events.

Requirements for Clinical Trials

1. Registration

1. • All clinical trials must be registered.
   • Registration must occur at or before the time of first patient enrollment.

2. Accepted Registries

1. • Clinical trials must be registered in a public registry that is a primary register of the WHO International Clinical Trials Registry Platform (ICTRP) or in ClinicalTrials.gov.
   • Catalyst Research Chronicles accepts trial registrations in any publicly accessible registry that meets these criteria.

3. Trial Registration Number

1. • The trial registration number must be included at the end of the abstract of the manuscript.

4. Secondary Data Analyses

1. • Secondary data analyses of primary (parent) clinical trials should not be registered as separate trials. Instead, these should reference the registration number of the primary trial.

Authors unsure whether their study requires registration can refer to the ICMJE FAQs for further clarification.