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What is a Clinical Research Trial?

Clinical trials are supervised research studies to assess the safety and efficacy of investigational drugs or treatments. A clinical trial is conducted to answer scientific questions and to find new and improved ways to help patients with the targeted condition. A clinical trial can accomplish many things for a given condition such as establishing the first effective treatment or finding a more effective treatment. Likewise, better tolerated treatments or new uses for existing treatments can be found through clinical research studies.

Clinical Trials: The Four Phases of Research

There are four phases of clinical trials:

Phase I Trials: This phase of clinical trials involves healthy volunteers. New drugs and treatments are tested on these human subjects to evaluate their safety and efficacy, as well as dosing and tolerability of the medications. Phase I trials may require inpatient stays for varying lengths of time.

Phase II Trials: This phase is conducted on a larger group of patients who are afflicted with the targeted condition for which the drug is intended to treat. Phase II research evaluates the investigational drugs’ toxicity and efficacy.

Phase III Trials: This phase involves the trial being conducted across multiple trial centers on large groups of patients. Phase III research further examines efficacy, safety and possible side effects.

Phase IV Trials: Post-marketing studies used to further examine benefits and risks of the drug over time. Phase IV research is conducted on patients who have been taking the drug regularly.

Common Questions:

Why Participate in a Clinical Research Trial?
Is there a difference between Clinical Trials and Treatment?
How are New Drugs Tested?

Learn More About Clinical Trials:

What Types of Clinical Trials are Available?
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