Clinical trials can be an exciting opportunity for patients to try a new drug or treatment and see if it helps their sarcoidosis symptoms. These trials are important because they advance sarcoidosis research and bring us closer to finding better treatment and a cure. An important part of any clinical trial is establishing eligibility criteria. Like in any scientific experiment, the groups that are participating must be uniform to an extent – this is to make sure that other factors are not influencing the data. If you see a new trial that you’d like to participate in, looking at the inclusion and exclusion criteria can help you determine if you are eligible.
What is exclusion criteria?
Exclusion criteria is a list of characteristics that disqualify a person from participating in a clinical trial. These characteristics can vary from demographic information like age, gender, or race to something as complex as comorbidities, organ dysfunction, or the use of other medications. The purpose of exclusion criteria is to create a patient population with little variation so that the data gathered in the experiment is most likely due to the treatment or drug being administered.
Different Types of Exclusion Criteria
In many clinical trials, you may notice an age range in their inclusion criteria. This is often due to the physical vulnerability of adolescents, children, infants, and the elderly. Oftentimes, elderly people are suffering from more than one condition and they are taking medications that might interfere with the trial. Young people, on the other hand, are still developing, and that can also interfere with clinical trial results. New drugs have inherent risks, so researchers often do not want to test the drug on age groups with weaker immune systems like young children and the elderly.
Multiple Chronic Conditions
The purpose of a clinical trial is to test the effects of a drug on one specific condition. Therefore, someone suffering from multiple conditions may not be eligible to participate in a particular clinical trial. This is because the drug may interact with the other conditions and produce results that could skew the data. Also, if someone is suffering from multiple conditions, it is likely that he or she is taking multiple medications, and those other medications could also influence the data, making medication use another disqualifying factor.
There is already an inherent risk in testing a new drug on human participants, however, that risk increases when a participant has a dysfunctional organ other than the organ on which the drug is being tested. For this reason, dysfunction in multiple organs is a common exclusion criterion in clinical trials. For example, someone with cardiac sarcoidosis may not be eligible for a trial about pulmonary sarcoidosis. The safety of patients is the number one concern. Plus, even if the participant does not experience adverse effects, the effects that they do experience could be a result of the drug interacting with the dysfunctional organ, which is not what the trial intended to test. This would be another example of data being skewed by other variables.
Stay Up to Date
The inclusion and exclusion criteria varies from trial to trial, so if you want to participate in a clinical trial, keep your eyes peeled – there may be one out there for you! You can stay up to date on upcoming clinical trials by signing up for regular updates on our website.
Here are some studies going on right now as well as their inclusion criteria:
- Study of Intravenous ATYR1923 in Patients with Pulmonary Sarcoidosis
- Adults living in the United States ages 18-65
- Biopsy-proven diagnosis of pulmonary sarcoidosis for greater than or equal to 1 year. Patients may also have skin or eye involvement.
- Patients with symptomatic or active disease based on pulmonary function tests, FDG-PET/CT scan, and an evaluation of the shortness of breath you experience
- Be on a stable dose of 10-25 mg/day oral prednisone or similar medication
- Weight between 55 kg (approximately 121 pounds) and 140 kg (approximately 308 pounds)
- Pulsar Trial for Individuals with Pulmonary Sarcoidosis
Be between 18 and 90 years of age
Have biopsy-confirmed sarcoidosis for >1 year prior to initial visit
Be on a stable prednisone dose for at least 4 weeks prior to initial visit
- Study on Heart Scarring in Gainesville, Florida
- Be diagnosed with sarcoidosis.
- Be 18 years of age or older.
- Study of ACZ885 (Canakinumab) in Patients with Pulmonary Sarcoidosis
- Participants must be between the ages of 18 and 80 years old
- Diagnosed with pulmonary sarcoidosis for more than one year
Criteria that may not allow for you to participate include:
Diagnosis of pulmonary hypertension requiring treatment
Women of child-bearing potential who are not using birth control
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