What's a clinical trial?
A vital step toward
what's possible.
Utilizing volunteers to study effectiveness and safety, clinical trials, and the participants are essential to advancing new therapies. Clinical research studies are conducted by either the sponsor of the study or a contract research organization (CRO) hired by the sponsor to oversee and manage the study. The process typically starts when a therapeutic device or compound is created by a pharmaceutical or biotechnology company.
In turn, a several years-long stage begins where new therapies are tested rigorously in laboratories to ensure their safety. Very few potential therapies make it through this testing phase, but those that do, move on to the pre-clinical phase, where testing in animals typically occurs.
Once past animal testing, the potential candidate is sanctioned by the Food and Drug Administration (FDA) for a multi-phased process of in-human testing. During the three phases of study, a drug candidate is introduced to increasingly larger patient populations. This takes place at clinical investigation sites (like ours) throughout the US and the rest of the world. Sponsors will select a clinical research site or a network of sites to begin conducting trials. These clinical trial sites will select volunteers who meet the proper criteria for testing.
The investigator sites administer the treatment on behalf of the sponsor, and then collect a whole host of information, including data on efficacy, safety, stability, and potential interactions, in addition to numerous other metrics. Upon demonstration of safety and effectiveness, the FDA will approve the therapy and the sponsor will send it to market.
Learn about specific clinical trial topics like joining a study on our FAQ page.
• • •