The Clinical Trial Process

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).

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.