Clinical research studies (also known as clinical trials) are medical research studies conducted with volunteers and play an integral part in the development of new therapies for diseases and health-related conditions.
All potential therapies, both devices and medications, must go through intensive testing. The process usually begins when a research company discovers a new compound or device. These research organizations, also known as sponsors, primarily include pharmaceutical and biotech companies.
Long before a new candidate drug or device ever enters a clinical trial, it is studied extensively in the laboratory setting. This phase typically can take several years. Only a few promising candidates make it through this phase and are allowed into the next phase of development which is comprised of pre-clinical or animal trials. Any candidate showing significant toxicity is eliminated from further study. Only a few are ultimately selected by the sponsor for a clinical trial, but only if sanctioned by the Food and Drug Administration (FDA).
The sponsor then chooses a clinical trial site to actually conduct the study. During this clinical trial phase, safety and effectiveness must be demonstrated. All new drugs and medical devices must be first approved by the FDA before being released into the public market. Understandably, in order to receive such FDA approval, the sponsors must present data that demonstrate safety and effectiveness.