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

Why is specifying an estimand important in clinical trials?

1. To determine sample size

2. To specify target attributes

3. To outline the protocol

4. To assess data accuracy

The correct answer is: To specify target attributes

Specifying an estimand in clinical trials is crucial because it defines the target attributes of the treatment effect that the study aims to estimate. An estimand provides clarity regarding what specific aspects of treatment effect are of interest, whether it's the efficacy under a specific treatment condition, the effect in a real-world scenario, or the implications of treatment adherence. This specification aids in making the trial's objectives clear and allows for a focused analysis, which aligns the study design, statistical methods, and data analysis with the primary goals of the research. It ensures that all stakeholders — researchers, sponsors, regulators, and participants — have a unified understanding of what is being measured and the context surrounding that measurement. The other options relate to different aspects of clinical trials. While determining sample size is an important step, it is more a function of study design rather than a purpose of the estimand. Outlining the protocol is critical for the overall conduct and regulatory compliance of the trial, but it doesn't specifically pertain to what is being estimated. Finally, assessing data accuracy is vital for the integrity of the study, but it is also separate from the concept of estimands. Defining an estimand focuses on the core questions the trial seeks to answer, leading to more relevant and