In my post a few days ago, I mentioned that to take part in a clinical trial, you will need to meet the Inclusion Criteria. What does it mean if you meet the Exclusion Criteria? That is what I want to discuss in this Blog post.
Any one who has reviewed a protocol on the US government site, www.clinicaltrials.gov., will have noticed that there are a set of criteria that are called Exclusion Criteria. Every clinical trial protocol has Inclusion and Exclusion Criteria. If you have not read my previous Blog post on Inclusion Criteria, please feel free to do so. The Exclusion Criteria are extremely important. If you meet any of the criteria on the list of Exclusion Criteria, it means that you will not be able to take part in the clinical trial.
The Exclusion Criteria are written for a number of reasons, including:
- Keeping the patients safe. If an Investigational Agent has a side effect in certain types of patients, then it may be prudent to exclude those patients.
- Ensuring the patients with disease that is poorly controlled will not enter the study. This is often for safety reasons, but it may also be to maximize the chance that a study will be successful.
- If you are taking medicines that may interact with the Investigational Drug, then it may be appropriate to exclude you.
- If you are suffering from a kidney disease, and the Investigational Drug requires that your kidneys are able to function well, you will need to be excluded.
- If you are suffering from a liver dysfunction, and the Investigational Drug requires that your liver is functioning well, to break it down, then you will be excluded.
- If you are over or under the age defined for inclusion, you will be excluded from the study.
- If you are suffering from a disease that requires you to take medicine that will interact with the investigational drugt, you will be excluded.
There are many other reasons why a patient may need to be excluded from a study. These will all be listed in the Exclusion Criteria. Read this section of the clinical protocol very carefully to ensure you do not meet any of the Exclusion Criteria.
It is important to bring your medical charts to the Informed Consent Discussion, where the review of Inclusion and Exclusion criteria will take place with Investigators and nursing staff. Bring any medicines that you are taking. This will help the investigators to determine if you are appropriate for inclusion in the study, and if you meet any of the Exclusion Criteria.
It is extremely important to be truthful during the Informed Consent process, to ensure that you are not harmed by taking part in the clinical trial. If you meet the Inclusion Criteria, and do not meet any of the Exclusion Criteria, you may be a good candidate for inclusion in the clinical trial. Your exclusion from a study does not necessarily mean that you cannot be given the Investigational Drug. You may be able to access the Investigational Drug on a compassionate -use basis, if your doctor believes the Investigational Drug may be of benefit to you.
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Lorna Speid. Ph.D
President of the Board
Putting Rare Diseases Patients First!(R)