What is a Clinical Research Study or Trial?

What is a Clinical Research Trial?

A clinical research trial or study comes about when a biotech, pharmaceutical, or device company wants to get regulatory approval for its product to market it.  In order to get the approval of an agency like the FDA, it is required to conduct research in humans or a "clinical trial".  The company that has the product is called the "Sponsor" of the clinical trial.  The product that is going to be studied can be a drug, device, molecule, or a combination of them and is called the "Investigational Product" or IP.  The Sponsor then comes up with a plan on how the clinical trial will be run.  These instructions also include safety and background about the Investigational Product.  The plan is called a "protocol" whose main purpose is to answer questions about how the IP works in  humans who participate in the trial.  The clinical trial can be in one country or can be worldwide in multiple countries.

Clinical research seeks to find cures for cancer, diabetes, genetic diseases, and more.   Clinical research professionals work as a team to innovate these medical breakthroughs.

A career in this field means learning how to protect the safety and well being of humans who participate in these trials while looking for the next generation of medical healthcare treatments.

The above information was tested for clarity in conversations with taxi cab drivers on trips to and from airports.

- Article by Laurel Latto, Certified Clinical Research Associate (CCRA)

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