What is Clinical Research?
Clinical research scientifically investigates new drugs and modalities in human participants to prevent or treat human diseases. Multiple research sites throughout the United States (and sometimes throughout other countries) are often used to conduct clinical studies, also called clinical trials. Progressive Clinical Research is a research site that has been conducting clinical trials for over 15 years.
Clinical trials are required for all new drugs before the FDA (U.S. Food and Drug Administration) will consider its approval for sale and marketing in the United States. During a clinical trial, the safety and efficacy of a new drug is studied in people called participants. The clinical trial is conducted by a research team composed of a principal investigator, who is usually a medical doctor, and specially-trained healthcare personnel.
Clinical research can be sponsored by a variety of entities, including pharmaceutical companies, National Institutes of Health (NIH), academic medical centers, physicians, and other groups.
Clinical trials require many different components to work together. Scientists test new ideas in the laboratory and in animal studies. The ideas with the most potential are advanced to the clinical research phase. Protocols are carefully written and include a set of specific requirements called inclusion/exclusion criteria that describe who can participate. The protocol is reviewed by an independent committee called the Institutional Review Board (IRB) to safeguard the participants.