Association of Clinical Research Professionals (ACRP) Certified Professional Practice Exam

Which of the following best describes the effect of an intercurrent event on a clinical trial?

1. It should always be avoided

2. It is detrimental to study integrity

3. It may complicate the interpretation of results

4. It has no effect on outcomes

The correct answer is: It may complicate the interpretation of results

An intercurrent event refers to any event that occurs during a clinical trial that is not part of the study protocol but can impact the participants or the study's results. Choosing that it may complicate the interpretation of results accurately reflects the nuances involved when these events occur. When an intercurrent event such as a change in medication, an additional illness, or any unforeseen circumstance happens, it can alter the trajectory of a participant’s condition or response to treatment. This means that when researchers analyze the data, they have to consider how these events may have influenced outcomes. If a significant number of participants experience intercurrent events, it may introduce variability that clouds the overall findings. As a result, drawing clear, actionable conclusions about the efficacy or safety of the intervention may be challenging. Understanding the potential complications introduced by intercurrent events is essential for maintaining the integrity of the study's conclusions and ensuring that any findings reflect the true effects of the intervention being tested on the intended population. This awareness informs the design of trials as well, promoting careful planning to mitigate the impact of such events when possible.