Well-designed research protocols that clearly differentiate between a registry study and interventional trial can cut down on review time, minimize questions from an institutional review board (IRB), and better ensure compliance and subject protection.
Differentiating registry studies and interventional trials is required to protect research participants, and is essential to ensure proper regulatory compliance. To distinguish between these two study designs, the inclusion criteria and the procedures involved in the research should clearly indicate what is within the research study and what is outside the scope of the research.
“A question that often comes up during 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,” says Jeffrey A. Cooper, MD, MMM, vice president for process and strategic improvement at WIRB-Copernicus Group, and Lindsay A. Abraham, JD, CIP, an attorney and the regulatory lead for the IRB chairs at Western IRB, a WIRB-Copernicus Group Company.
“Reviewing the protocol should provide the answer to this question, but often it does not,” the authors suggest in a white paper on “Interventional Clinical Trial or Registry Study? Writing Protocols that Demonstrate the Difference.”
The problem: The risks and benefits of the research may not be identified and analyzed accurately, and consent documents may fail to identify research procedures and research risks. The possible consequences: Subjects would not be adequately informed as to what their participation in the study involves.
An example of an interventional trial that may not be identified as such is a study where subjects are assigned to be implanted with an artificial hip system approved by the U.S. Food and Drug Administration, according to Cooper and Abraham. In their example, the research is described as a postmarketing study. The protocol indicates that subjects are eligible to enroll in the study based on their need to receive a hip replacement, and meeting the specific indications for use of this device. These subjects then undergo hip replacement surgery. Data are collected before, during, and after the surgery. Investigators state that subjects will receive the hip replacement regardless of whether they are in the research study. Because of these factors, this could easily be misconstrued as a registry study.
“However, since the protocol inclusion criteria prescribe use of the device as part of the research, the hip replacement operation using this medical device is a research procedure and the protocol is an interventional trial,” the authors conclude.
Under the hypothetical scenario, the consent form would need to include the hip replacement surgery as a research procedure, as well as details on the risks of the surgery and the risks of the artificial hip itself. If the inclusion criteria were modified to indicate that subjects whose surgeons decided to use the device independent of the research would be enrolled, and data collected during and after implantation, the protocol would now be a registry study.
To receive a copy of the white paper, visit the FDA News website.
Author: Michael Causey