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Interventional Clinical Trial Or Registry Study? Writing Protocols That Demonstrate The Difference
By Jeffrey A. Cooper, MD, MMM, Vice President, Process & Strategic Improvement and Lindsay A. Abraham, JD, CIP, IRB Chair – Regulatory Lead, WCG IRB
Interventional studies, also called clinical trials, are those in which a drug, device, or procedure is used on research participants as part of a research protocol, and outcome data are collected. Registry studies are observational studies in which the drug, device or procedure being evaluated is prescribed to patients by treating physicians, and outcome data are collected. The critical difference between these study designs is whether the intervention occurs because it is a component of participation in a research protocol, or because a clinical decision was made that the intervention was the appropriate treatment option.