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.
A question that often comes up during Institutional Review Board (IRB) review is whether a research study involves a clinical intervention occurring within the context of the research, or if the research only involves collection of data about an intervention occurring outside of the research. Reviewing the protocol should provide the answer to this question, but often it does not.
In this paper, we will address how sponsors/investigators can design research protocols that clearly indicate whether the clinical intervention is occurring within, or outside of the context of the research, and why this distinction is critical in ensuring regulatory compliance.