Clinical Trial Basics

Clinical research of drugs and medical devices proceed sequentially through four levels.

Phase I includes first-in-man trials. These studies usually take place at dedicated research facilities and recruit healthy volunteers to be subjects. Thus, Phase I studies are not appropriate for the private practice setting.

Phase II trials for new drugs generally involve pharmacokinetic (PK) and pharmacodynamic (PD) testing and analysis of blood samples. Typically, Phase II studies are conducted at dedicated research facilities that recruit patients who have a specific condition or disease related to the drug or medical device being studied. However, Phase II trials might be conducted in the private practice setting, depending upon the nature of the physician's practice.

Phase III trials are studies designed to obtain FDA-approval for a new medication or medical device. Frequently, these trials are suitable for the private practice setting.

Phase IV trials are studies of drugs or devices which have already received FDA approval. These are called "post-marketing studies", and are usually registry studies that collect information from people who are taking the FDA-approved drugs or using the FDA-approved medical devices. These studies are performed almost exclusively in private practice settings, and are designed to collect information about the long-term effects of the drug or medical device. Phase IV studies usually require an evaluation of how well the drug/medical device is working, as well as the patient's health status and quality of life. Questionnaires may be used to collect this information, and study procedures (such as blood sample collection) are usually limited.

Each phase of clinical trials for new drugs or new medical devices is overseen by an Independent Review Board (IRB). Before a clinical trial begins, the IRB must review the study to ensure that it is scientifically and ethically sound, and that all study procedures, risks, and benefits are disclosed to participants in an Informed Consent document. The U.S. Food and Drug Administration (FDA) and the U.S. Department of Health and Human Services Office of Human Research Protection provide regulatory guidance and auditing of clinical research to verify that it is being done in compliance with the law.

Sentral Clinical Research Services pledges to support the physician private practice and to uphold the highest standards of patient-protection and research quality to ensure the integrity of the clinical trial endeavor.