When designing a clinical trial, why is it important to define the study population?

Defining the study population is crucial because it ensures that the trial targets the appropriate group for evaluating the investigational product (IP). A well-defined population supports the study objectives by providing reliable and interpretable data that can address the research questions.

GCP guidelines emphasize the need for a clearly defined study population to ensure the generalizability and accuracy of trial results.

"The study population must be clearly defined to ensure that the trial data are relevant and applicable to the intended patient group."

Objectives:

Enhance the scientific validity of clinical trial outcomes.

Support the accurate interpretation of efficacy and safety data.