Clinical Trial
A structured research study conducted in human participants to evaluate the safety, efficacy, and optimal dosing of a medical intervention. Clinical trials are the required pathway for regulatory approval and proceed through four phases, from initial safety testing to post-marketing surveillance.
Technical Context
Clinical trials follow a regulatory framework established by ICH-GCP (International Council for Harmonisation Good Clinical Practice) guidelines. Key requirements include: written protocol specifying objectives, design, methodology, and statistical analysis plan; ethics committee/IRB approval before enrolment; informed consent from all participants; data integrity through case report forms and electronic data capture; monitoring by the sponsor or contract research organisation (CRO); adverse event reporting to ethics committees and regulatory authorities; and trial registration on public databases (ClinicalTrials.gov, EU Clinical Trials Register). The drug development process from preclinical through Phase III typically takes 10-15 years and costs $1-3 billion. Only approximately 12% of drugs entering Phase I eventually receive approval.