Certified Clinical Research Associate (CCRA) Practice Exam 2025 – Complete Preparation Guide

The Intention-To-Treat Principle emphasizes the importance of following up on subjects regardless of their treatment compliance. This approach is crucial in clinical trials as it helps maintain the randomization of the treatment assignment and minimizes biases that might occur if participants are excluded from the analysis based on their adherence to the treatment protocol. By including all randomized participants in the groups to which they were originally assigned, the analysis reflects the real-world scenario of how a treatment might perform across a diverse population, including those who may not fully comply with the treatment.

This principle helps in preserving the integrity of the trial and ensures that the results are applicable and generalizable, making it a vital aspect of designing and interpreting clinical research. It also accounts for the possibility of dropouts or crossovers, providing a more conservative estimate of treatment effect. This is contrasted with evaluating outcomes only for compliant subjects, which could lead to an overly optimistic view of the treatment's efficacy, as it may not represent the broader patient population who would be taking the treatment in a clinical setting.