Inclusion and Exclusion Criteria in Clinical Research

Have you ever applied for a research study only to be told you were not eligible? While this can be incredibly frustrating, there are valid reasons for this that we wanted to touch on. This is something that comes up in our practice daily as a clinical research site. We must assess each potential patient for what is called inclusion and exclusion criteria for every study; and for each of them, that criteria is different.

What is inclusion and exclusion criteria?

Inclusion criteria is criteria that must be met for a person to be eligible to participate in the study. Exclusion criteria is criteria that if a person meets, they would then not be eligible for the study.

All research studies and clinical trials have these criteria in place. Those who develop the protocol for the study, the pharmaceutical sponsor, determine these criteria for who is and is not eligible for the study for a variety of reasons.

Why is it important?

First and foremost, patient safety is the priority of all researchers. In order to maintain and ensure safety of all research participants, certain criteria must be in place. Some studies may exclude patients with certain diagnoses and conditions, lab abnormalities, and medications if participating in the study may pose a risk to them. These are just a few of many examples.

Another reason for these criteria is efficacy of the study. In order for researchers to truly be able to measure what they are trying to understand from a study, they have to narrow down their participants in some ways to not lose sight of what they are studying.

These are all reasons why we have such a comprehensive intake and pre-screening process for our studies. Your safety is our priority, and we must ensure that all study procedures and criteria are followed accordingly.

How can I find out if I am eligible?

This is usually something assessed by the patient recruitment specialist or clinical coordinator and intake team when you first indicate your interest in a study. Members from the team will look at the inclusion and exclusion criteria to determine whether you are eligible and will then discuss your eligibility with you.

If you’re wondering about eligibility for any of our available studies, be sure to contact us here or call 610-891-7200 to discuss your eligibility.

What if I am not eligible for a study?

Every study is different. It can be frustrating to not qualify for a study, but we don’t want you to lose hope. There are a myriad of research studies and clinical trials available at any given time, and the studies are ever changing as new ones begin. If you have applied for a study that you weren’t eligible for, there is always a possibility that a new study will start with different criteria; as research is evolving every single day.

You can also always talk to your medical and/or mental health care team to discuss different options that might be able to help if you are unable to participate in a research study. New treatment plans and options are evolving at a rapid rate.

Never give up, new options are always out there.

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