Clinical Trial Registration

Before registration requirements existed, companies and researchers could run multiple trials, then publish only the ones showing positive results — burying negative findings. This selective reporting distorted the medical evidence base. Trial registration counters this by creating a time-stamped public record of the study protocol, primary outcomes, and sample size before data collection begins. ClinicalTrials.gov (US) is the largest registry, mandated by the FDA Amendments Act (2007) for trials of FDA-regulated products. The WHO International Clinical Trials Registry Platform (ICTRP) aggregates data from national registries worldwide. Other major registries include: EU Clinical Trials Register (EudraCT/CTIS), ISRCTN registry, and national registries in China, India, Japan, and others. The ICMJE policy (2005) requires that any interventional trial enrolling human subjects be registered in a qualified public registry before enrolling the first participant. Failure to register can result in: inability to publish in major journals, regulatory penalties, loss of funding, and reputational damage. Registration also promotes collaboration — researchers can identify ongoing studies on similar topics and avoid duplication. Results reporting requirements now mandate that sponsors post summary results within 12 months of study completion.