Clinical Trial Registration

1Detailed Explanation

Clinical trial registration is required by the ICMJE, WHO, and most major journals as a condition of publication. Key registries include: ClinicalTrials.gov (US), ISRCTN (UK), EU Clinical Trials Register (EU), Chinese Clinical Trial Registry (ChiCTR). Required registration items include: trial ID, study design, participants, interventions, outcomes, eligibility, contact, and timeline. Registration must occur before enrollment or before submission to ICMJE-compliant journals. Results registration within 12 months of primary completion date is required by ClinicalTrials.gov. Protocol amendments must be documented. The CONSORT statement recommends trial registration. Prospective registration prevents selective reporting and publication bias.

2Examples

• A.ClinicalTrials.gov registration: NCT05812345 — 'A Randomized Controlled Trial of Drug X vs. Placebo in Patients with Disease Y'
• B.Trial registration statement in manuscript: 'This trial was registered at ClinicalTrials.gov (NCT05812345) on March 1, 2024, before patient enrollment.'

3Why It Matters in Research

Prospective trial registration is an ethical imperative and is now a publication requirement at all major medical journals. Unregistered or retrospectively registered trials face rejection.

4Related Terms