|
The Baptist Clinical Research department was created because of the increasing demand for participation in research. We enrolled our first patient in 1999, though Baptist Health Care's research experience dates back to the seventies. What are Clinical Trials?
A clinical trial (also clinical research) is a research study in human volunteers to answer specific health questions. Carefully conducted clinical trials are the fastest and safest way to find treatments that work in people that can often improve health. Interventional trials determine whether experimental treatments or new ways of using known therapies are safe and effective in controlled environments. Observational trials address health issues in large groups of people or populations in natural settings. What happens during a clinical trial?The clinical trial process depends on the kind of trial being conducted. The clinical trial team includes doctors and nurses as well as social workers and other health care professionals. They check the health of the participant at the beginning of the trial, give specific instructions for participating in the trial, monitor the participant carefully during the trial, and stay in touch after the trial is completed. Some clinical trials involve more tests and doctor visits than the participant typically require for the thretment of an illness or condition. For all types of trials, the participant works with a research team. Clinical trial participation is most successful when the protocol is carefully followed and there is frequent contact with the research staff. Why participate in a clinical trial?Participants in clinical trials can play a more active role in their own health care, gain access to new research treatments before they are widely available, and help others by contributing to medical research. What are some benefits of being part of a research study?If you join a study that compares treatments, you get the best accepted treatment for the condition you have (called standard treatment) and the new treatment that doctors hope will be better than the standard treatment. Information gatherred in studies help people in the future. Who makes sure my rights are protected?Groups of experts at the national and local levels approve research studies before they begin. One of the most important groups is the institutional review board (IRB). The IRB's job is to review research studies and make sure they are run safely and fairly. All clinical trials should be reviewed by an IRB, that comprises doctors, nurses and people from the community. What is an Institutional Review Board (IRB)?Under FDA regulations, an IRB is an appropriately constituted group that has been formally designated to review and monitor biomedical research involving human subjects. In accordance with FDA regulations, an IRB has the authority to approve, require modifications in (to secure approval) or disapprove research. This group review serves an important role in the protection of the rights and welfare of human research subjects. Do I have to take part in a clinical trial?No. Taking part in a research study is up to you. It is important to look at all of your treatment options with the help of your family and doctor. This will help you decide if a study is the best way to treat your condition. You and your family should ask questions before you decide to take part in a research study. Be sure to get all the information you need before you decide to take part. Questions to ask:
Tip: Write out a list of your questions and concerns to discuss with your doctor. Baptist Clinical Research |
Copyright © 2008 Baptist Health Care. All rights reserved.
Pensacola FL Florida
