Clinical Trial
Also known as: Clinical Study, RCT, Pivotal Trial, Feasibility Study
A structured study evaluating the safety and/or efficacy of a medical product in human subjects.
Full Definition
Clinical trials are essential for regulatory clearance/approval and reimbursement establishment for most HealthTech and many Digital Medicine products. They range from small feasibility studies (20–50 patients) to large randomized controlled trials (500–2000+ patients). Trial design, endpoints, and sample size are driven by regulatory requirements and the evidence standards of payors and KOLs. Clinical trials are typically the largest single cost item in a HealthTech company's budget.
Example
A diagnostic device company designs a 200-patient prospective study at three academic medical centers to demonstrate sensitivity and specificity versus the current standard of care — the clinical data package required for its 510(k) submission.