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How are drugs tested?

U.S. laws and regulations dictate that drug testing must go through various stages, or phases, to assess its efficacy and safety for targeted medical conditions in humans. By passing a new drug or treatment through these phases, the drug can be proven suitable for treatment and marketable to the public.

First, the new drug undergoes chemical and animal studies during a laboratory investigation to gain a basic understanding of how the drug works. The second phase of drug testing involves the evaluation of the drug’s safety for use in healthy human subjects. If the drug passes this phase successfully, it will move on to be tested on a group of patients afflicted with the targeted condition to assess its effectiveness in treating the condition.

Medication Testing in Phases III and IV

Once a drug makes it past the first two phases, the new treatment enters advanced clinical trials. Phase III trials involve a larger group of patients receiving the investigational drug to further assess its safety and efficacy. Following Phase III, an application for the new drug is prepared and submitted to the FDA to obtain marketing approval. If the FDA deems the drug safe and effective, it will gain clearance for marketing.

The Full Scope of Medication Testing

Prior to the four phases of drug testing, the FDA and an Institutional Review Board (IRB) must review the study protocol. The FDA and IRB will determine the benefits and risks of the clinical trial as well as ensuring the participants are fully informed on both. Once this protocol approval is achieved, the four phases of drug testing are initiated. The entire process is designed so that the efficacy and safety of an investigational drug for treatment on human subjects can be determined prior to being introduced in the market.

Common Questions:

What is a Clinical Research Trial?
Why Participate in a Clinical Research Trial?
Is there a difference between Clinical Trials and Treatment?

Learn More About Clinical Trials:

What Types of Clinical Trials are Available?
Phase I Clinical Trials
Phase II Clinical Trials
Phase IV Clinical Trials
Glossary of Clinical Trial Terminology
Alabama Health Resources
Brief History of Clinical Trials
Find Clinical Trials

Know Your Rights as a Participant:

Your Patient Rights
Patient Privacy Rules
Informed Consent Agreement
NIH Patient Bill of Rights
Legal, Ethical, and Safety Issues