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What types of trials are there?

There are typically two groups of clinical trials: comparative studies and open label studies. There are inherent differences between the two types of trials, which both evaluate the safety and efficacy of investigational drugs and treatments.

Clinical Trials: Comparative

Comparative, or controlled, clinical research studies involve two groups of patients. One group receives the investigation drug, while the control group receives a placebo, existing treatment or none at all. Another type of comparative trial is conducted as “double-blind,” meaning that neither the patients nor the investigators are aware of which group is the control and which is receiving the drug.

Clinical Trials: Open Label

Open label trials are the opposite of comparative trials, meaning that no control group or blind is used. Therefore, both the investigators and patients are aware of who is receiving the investigational treatment.

Clinical Trials – Phase I-V

The four phases of clinical trials comprise the entire drug approval process, which can typically take eight to 10 years to complete. The four phases of clinical trials are as follows:

Phase I Trials: Learn more about Phase I trials. Phase I research is the first step in evaluating investigational drugs for safety, dosing and efficacy.

Phase II Trials: Click here to read more about Phase II trials. Phase II research further assesses the new drug’s safety, efficacy and toxicity.

Phase III Trials: Learn more about Phase III trials, the phase that ultimately determines the investigational drug’s efficacy across multicenter trials.

Phase IV Trials: Click here to learn more about Phase IV trials, which are post-marketing trials conducted to examine the drug’s long-term benefits and side effects.

Common Questions:

What is a Clinical Research Trial?
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:

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