Types of Clinical Trials
The U.S. Food and Drug Administration (FDA) requires that clinical trials are conducted before a medication, device, or medical procedure can be manufactured and made available to patients. The process of developing new therapies drugs is long, complex, and expensive. Unfortunately, investigational products are more likely to fail at any given stage in the research process, than to succeed.
There are two main types of clinical trials: observational and interventional:
Observational
Observational clinical trials do not test medications or treatments. Researchers observe research participants by monitoring their health over a period of time. These studies offer data to help advances our understanding of certain conditions, and how to treat them.
Interventional
Interventional clinical trials test the safety and effectiveness of an investigational product or treatment.
There is a series of phases in which clinical trial are conducted:
Phases I, II, III and IV.
Phase I
Phase I trials are the first stage of testing investigational products involving humans. Phase I trials typically involve smaller groups of healthy volunteers and require strict and consistent parameters to standardize the group of volunteers. Phase I trials examine the safety, dosing level, drug formulation and potential side effects of the investigational product.
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Phase II
Phase II trials are performed on larger groups of volunteers to assess the efficacy and safety of the investigational product. Phase II trials incorporate patients with specific diseases or conditions.
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Phase III
Phase III trials are typically conducted across multiple research sites, and involve large groups of volunteers. Phase III trials aim to gather information on the effectiveness of the investigational medication, device, or medical procedure over a longer period of time. It is during this phase that researches evaluate whether the treatment benefits outweigh any potential risks.
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Phase IV
Phase IV trials are conducted after a treatment has received FDA approval and been made available to patients. These trials further evaluate potential long-term side effects and new uses for the approved medication, device, or intervention.
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