A clinical trial is a form of research in which new treatments, drugs, diagnostic tests, procedures or other therapies are tested via human participants to see if they are safe and effective.

Carefully conducted clinical trials are the fastest and safest way to find successful treatments.

A pharmaceutical, medical device, or other organization contracts with a research site, such as Beyer Research, to conduct a trial to determine such things as effectiveness, dosage of a potential treatment, etc. Typically, Beyer Research will be one of several locations from around the world performing the study (i.e., doing the clinical research.)

The Drug Development Process

• Preclinical: Testing in labs and animals.
• Phase I: Checks the safety of an experimental drug through studies in a small number of people, usually healthy volunteers.
• Phase II: Safety continues to be evaluated, as well as the best dosage, and effectiveness, in a larger number of people who have the disease or condition.
• Phase III: Effectiveness is studied in a larger number of people (who have the diagnosis under study, such as diabetes). After Phase III studies, the manufacturer will apply for the medication’s approval with the US Food and Drug Administration.
• Phase IV: After The FDA approves a medication. Continued evaluation of safety may take place in a larger population over more time.

You can see that this is a long process, and it can take up to 15 years to develop a new medication. You are playing a critical role in the process of evaluating a potential treatment for people with illness. Thank you!

For more information on clinical trials, please see Resources & Links.