What Are Exclusionary and Inclusionary Clinical Trial Criteria?

What Are Exclusionary and Inclusionary Clinical Trial Criteria?

July 28, 2016

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.

What is the difference between inclusionary and exclusionary criteria?

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.”

Why do these criteria exist?

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.

Clinical trial requirements and criteria

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:

  • Are between 18-75 years old
  • Have low testosterone (we can do the test if levels are unknown)
  • Have no history of prostate or breast cancer

Our Kidney disease study participant qualifications are:

  • Age range between 18-80
  • Presently have kidney impairment or disease
  • Currently seeing a nephrologist and taking medicine such as: Procrit® or Aranesp® for low blood count, or PhosLo® or Renagel® for high blood phosphorus

Our Liver Studies participants should:

  • Be between 18-75 years old
  • Have liver impairment or disease
  • Study volunteers are more likely to qualify if presently taking medicines such as spironolactone, lasix®, lactulose, aldactone®, or Rifaximin
  • Individuals with abdomen fluid (called ascites) or cirrhosis are also welcome