What is the drug development process?

Following is a summary of the clinical trial process which we hope you find useful in your journey towards understanding if clinical trial participation is right for you and/or someone you care about. It is our hope that by providing you with this information, you will become more familiar with the drug development process and explore further with your physician the possibility of clinical trial participation.

The process of developing new drugs is complex, time consuming, expensive and risky. Unfortunately, most drugs in development never make it to patients. The challenge is even greater for the development of drugs for diseases that affect limited numbers of people. Drug development is regulated by the Food and Drug Administration (FDA). The FDA estimates on average, it takes 8 years to study and test a new drug before it becomes available for patients.

The search for a new treatment begins in the laboratory with scientific research about a particular disease and to identify potential compounds that can be made into drugs to treat the disease. Potential compounds are analyzed for their physical and chemical properties, first in the laboratory and then in animals to determine their pharmacologic properties and toxic effects. Before a new drug can be approved for use in humans, it must be thoroughly tested in the laboratory.

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