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A clinical drug trial is a scientific study that helps to determine how a new medicine or treatment works in humans. Through clinical trials, clinicians find new, and potentially better ways to prevent, detect, diagnose, control and treat illnesses.
Many years are spent researching and testing medications to determine the safety and usefulness before they are ever tried in humans. The Food and Drug Administration (FDA) requires that clinical drug trials in humans be conducted before a medication is approved for use in the general public.
Clinical drug trials are carried out in research centers like Omega Medical Research, in doctors’ offices, or at medical centers. At each site, a Principal Investigator who is a physician is selected to carry out the study’s protocol. The protocol is a carefully designed by an FDA approved study plan created by the sponsor of the study.
All study information is submitted to an Institutional Review Board (IRB). An IRB is typically composed of health care professionals and community members not associated with the research site. This group makes sure all FDA and protocol requirements are followed. This board reviews all activities involved in the study and determines if the study is safe, ethical and offers no extreme risks to the volunteer. The research site, where the volunteer goes to participate, collects all the data involved in the study and reports any safety information to the sponsor and the IRB that is collected while the volunteer is in the study. The sponsors of research studies are pharmaceutical companies, research institutions or other health organizations that design the protocol and fund the research.
All data collected in the study is submitted to the sponsor in a most confidential manner. Those who analyze the data do so without ever knowing the volunteers name, address or other personal information that would identify the participant.
Although it is ideal for volunteers who enter the study to stay in the study until it is complete, a volunteer is just that, a volunteer who can withdraw for the study at any time and for any reason. (See Patient's Rights)