Understanding Per Protocol Analysis in Clinical Studies

What does per protocol analysis entail in a clinical study?

• A. Analysis of only patients who dropped out
• B. Analysis of all subjects who completed the study per the protocol
• C. Analysis of data from all patients enrolled
• D. Analysis of only those who experienced an AE

Answer: (B)

Per protocol analysis refers to the practice of analyzing data from participants who have completed a clinical trial according to the study's specified protocol. This type of analysis includes only those participants who adhered strictly to the study’s requirements, such as following the treatment regimen, attending scheduled visits, and completing assessments as outlined in the protocol. By focusing on this subgroup, per protocol analysis aims to evaluate the treatment effect under ideal circumstances, reflecting a clearer picture of the intervention’s efficacy without the confounding effects of non-compliance or protocol deviations. Because it limits the analysis to those who fully completed the study as intended, this method can provide insights into the true impact of the treatment being tested. Other options reflect different approaches to data analysis. For instance, analyzing patients who dropped out or those who experienced adverse events does not align with the core intent of per protocol analysis, which emphasizes adherence to the protocol. Analyzing data from all patients enrolled may include those who did not comply with the study requirements, thereby diluting the results and potentially introducing bias.

Are you gearing up for the Certified Clinical Research Associate (CCRA) exam? One essential concept you’ll want to grasp inside and out is per protocol analysis—a pivotal part of our data analysis toolkit. So, what exactly does it mean, and why is it so vital for clinical research? Let's break it down, shall we?