BSHRI-CORE Labs Clinical Research Program
Clinical trials are biomedical or health-related research studies, approved by our Institutional Review Board, involving consenting human beings. They are conducted to establish the safety and efficacy for new drugs or devices. These trials are closely regulated by a number of Health and Ethics Committees and the Food and Drug Administration.
Clinical trials can vary in size and scope. There are a number of phases each drug or device goes through to obtain FDA approval for marketed use. The focus of each phase varies, and in part determines, the number of people participating in the study and the number of investigators involved in the trial.
The participants are patients who meet the study criteria for a specific clinical trial. These patients are given the option of participation and are informed about what will happen during the course of the trial. They are also given an explanation of the associated risks and benefits of being a participant. Choosing not to participate in a trial does not affect a patient's care. Those patients choosing to participate will embark on a journey that advances medicine for nationwide and global communities. They can rest assured knowing that they are protected by federal and local ethical codes pertaining to the research they are involved in, with their individual safety being paramount.
The investigators are grouped into study teams consisting of a physician who specializes in the area of interest that pertains to the drug, device, or procedure under investigation; the members of the physician's medical staff who help oversee the patient's safety during the trial; and a number of research staffers who oversee the data collection and ensure regulatory compliance. Investigators also have the right to decide if they would like to participate in a trial, and therefore may choose not to participate if they feel that the study is not in the best interest of their patients.
The SHRI-CORE Labs and Physicians of The CORE Institute take pride in their contributions to the body of health care knowledge and the development of new treatment modalities through their participation in clinical trials.