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What to Know about Clinical Trials for Primary Immunodeficiency Diseases

The safety and effectiveness of new medications and new medical devices depends on clinical research to provide the Food and Drug Administration (FDA) with enough information to decide to approve or reject these products.

Human testing, also known as a clinical trial or protocol, is necessary to develop safe and effective products with limited side effects, while providing the most therapeutic benefit. Potential new treatments are usually studied in laboratory animals first to determine whether they are safe enough to test in humans.

To make sure that new product being tested will work for different groups of people, it is important that the participants in the clinical trials are from different ages and genders. This is the best way to test potential treatments to see whether they should be approved for a larger group. A treatment could be a drug, medical device or a biologic, such as a vaccine, blood product or gene therapy. ‘New’ does not always mean better which is why the clinical research is so important.

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