If you’ve been involved in research or read about research studies involving human participants, you’ve likely heard the terms “inclusion and exclusion criteria.”
While the definitions of inclusion criteria and exclusion criteria seem fairly self-explanatory, it is important to understand some background on why these criteria are utilized.
Let’s start by defining a couple of terms and then we’ll dive into some of the reasoning behind utilizing inclusion and exclusion criteria.
While eligibility criteria may feel restrictive, they are an essential element for research involving human subjects because they help ensure that treatments are safe and effective for a range of patients.
Inclusion and Exclusion criteria vary from study to study, especially because a new treatment may utilize a very specific approach and a very specific group of participants is needed. Inclusion and Exclusion criteria are never meant to reject potential participants personally, but rather to keep them safe. Often, the initial criteria are very specific, and if the treatment is successful, the criteria may broaden during a future phase of the study.
What are some common inclusion criteria for Ataxia related studies?
- Age ranges: Each study varies, and if a study allows participants under 18, the participant will need consent from a parent or guardian. Because Ataxia typically affects middle aged people, the age range is often targeted to reflect middle age.
- Diagnosis: A confirmed diagnosis by a neurologist for the specific type of ataxia or neurodegenerative disease that the study is evaluating.
- Willingness to participate and give informed consent
What are some common exclusion criteria for Ataxia related studies?
- Comorbidities: Other conditions a person may have that could put them at risk if they participated. Some conditions are excluded if they may affect the results of the study. Some examples may include dementia, cancer, liver disease, and/or severe psychiatric disease.
- Medications: Some medications may not be compatible with the study’s treatment protocol.
- Inability to undergo MRI scan: Some studies require an MRI scan as part of the study protocol. If a participant is unable to participate in an MRI related to weight, cognitive function, or other reasons, they may be excluded.
- SARA score outside targeted range: The Scale for Assessment and Rating of Ataxia (SARA) is often used to rate a person’s severity of ataxia. Some studies require a specific performance on this scale to be included in the study. This is because this scale is often used to show progress and change in disease over time as a measurement during the study.
Eligibility criteria are a crucial part of research studies and often are determined strategically by the investigators and approved or modified by the Institutional Review Board (IRB) or Ethics Committee. The primary use of eligibility criteria is to ensure participants’ safety and help researchers ensure that they can answer the questions they are studying to find future treatments for ataxia.
For a list of current Ataxia related studies, visit https://www.ataxia.org/help-develop-new-treatments/
Evaluating Inclusion and Exclusion Criteria in Clinical Trials: https://www.fda.gov/media/134754/download
Learn More About Clinical Trials
Check out our other educational blogs about Clinical Trials.
Getting Involved with Ataxia Research
Taking part in research is one way to help accelerate the development of treatments for ataxia. Some people like playing an active role in improving our understanding of ataxia by Read More…
Advancing Research by Joining the CoRDS Patient Registry
The Coordination of Rare Diseases at Sanford (CoRDS) coordinates the advancement of research into 7,000 rare diseases via data sharing and study recruitment. CoRDS works with advocacy groups such as Read More…
The Difference Between Observational and Interventional Studies
There are two main categories of human clinical trials: (1) observational studies, and 2) interventional studies. Both types of clinical studies are essential to developing new therapies for rare diseases Read More…
All About Cerebral Spinal Fluid (CSF) Donation
DISCLAIMER: The information provided in this article is for informational use only. NAF encourages all readers to consult with their primary care provider, neurologist, or other healthcare provider about any Read More…
How Do I Know if I Qualify for a Research Study
If you’ve been involved in research or read about research studies involving human participants, you’ve likely heard the terms “inclusion and exclusion criteria.” While the definitions of inclusion criteria and Read More…
How COVID is Evolving Participation in Research Studies
Made with Visme Infographic Maker Read More…
Clinical Trial Phases
Let’s chat about Clinical Trial Readiness with a focus on Ataxia. Clinical trials ensure that treatments are safe and effective before they gain approval for widespread use in humans. Clinical Read More…
What does a placebo mean? A placebo is a simulated substance that has no therapeutic effect or active ingredients. Often, a placebo looks, feels, and tastes like other therapies being Read More…