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Sarcoidosis

Clinical Research and Sarcoidosis


One topic that often brings an emotional response from patients is medical research. Clinical medical research is medical research that involves people. Other forms of research include animal research, basic science research which deals with molecules and cells, and translational research which is research of molecules or cells from people and therefore indirectly has an impact on patients.
In order to participate in medical research, the subject must be adequately informed about the research that they are being asked to participate in. This can be difficult because many types of clinical research are complex and difficult to clearly explain. However, you should not agree to participate in a research study until you understand the research study to your satisfaction. This includes:

  •  Understanding the purpose of the research
  • Potential risks of your participation in the study
  • Potential benefits of the study to you and to other people who have the disease
  • Alternative courses of action available to you in terms of treatment should you not want to participate in the study
  • Any costs that you may incur by participating in the study

You should not participate in a study if you are not given an opportunity to ask questions about the study and they are not answered to your satisfaction. Your agreement to participate in the study should be voluntary, and you should be free to change your mind about participating in a study even if you have already started to participate. Your agreement to participate is usually documented by your signature on a consent form that completely describes the study, including its risks and benefits.

Many clinical research studies are drug studies. There are many different types of drug studies. Probably the most powerful ones are randomized, double-blind placebo-control trials. These are studies where the patients are chosen at random to receive the drug that is being studied or a placebo, which is an inactive substance that should have no activity to treat the disease. Sometimes, instead of a placebo, the alternate treatment is a drug which represents a standard form of care.

For example, in the case of sarcoidosis, a study drug may be compared with steroids such as prednisone, which are usually the standard treatment of sarcoidosis. A double-blind study means that neither the study subject nor the personnel conducting the study know if the patient is receiving the study drug or the placebo. Studies are often made double-blind, because if either the doctor or patient knew if they were receiving the study drug or placebo, it may bias their opinion of how the medication is working. This is an extremely important aspect of sarcoidosis drug treatment studies, because sarcoidosis often gets better without receiving any medication. So, if every patient received the study drug and half of them got better, it might mean that the study drug worked. However, it might be that half of the patients were destined to get better from their sarcoidosis even without any medication, and therefore, the study drug did nothing. Including a group of patients into a study who are receiving a placebo allows the investigators to compare the response of the subjects who received the study drug to those who received no therapy. This will help determine if the drug is really having a beneficial effect.

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