Inclusionary and exclusionary criteria are specific limitations that clinical researchers place on a recruited study population. Researchers may screen and select specific participants in order to isolate variables that pertain to the experimental medication’s safety, effectiveness, dosing recommendations, or side effects.
Inclusionary or exclusionary factors include age, gender, weight, ethnicity and medical history. These variables are closely connected to a specific medication’s effectiveness and metabolic breakdown in the body; consequently, it is important for researchers to control these variables for the benefit of the study.
According to the National Institutes of Health, “Inclusion and exclusion criteria are not used to reject people personally; rather, the criteria are used to identify appropriate participants and keep them safe, and to help ensure that researchers can find new information they need.”
Excluding or including a specific variable can have a dramatic impact on the volunteer population, and thus the scientific validity of the researcher’s findings. Selecting the right group of participants enables researchers to generate more accurate data.
For instance, if a researcher excludes young men from a study about a medication’s effectiveness, additional research will be required before a manufacturer can move forward with mass distribution.
Pre-existing conditions and requirements vary depending on a researcher’s study protocol. Currently, at OCRC, our studies have slightly different criteria.
Our Low Testosterone study requires that participants:
Our Kidney disease study participant qualifications are:
Our Liver Studies participants should: