What is a Clinical Trial?
A clinical trial is a medical research study on human beings that follows a plan called a protocol. Many clinical trials test the safety and effectiveness of new drugs or devices that are seeking regulatory approval. A clinical trial protocol describes what types of people may participate in the trial, when the tests and procedures will be done, which treatments will be used, and how long the study will last. A subject who is participating in a clinical trial is seen regularly by the research staff to monitor their health and to determine the safety and effectiveness of their treatment. Participants in clinical trials have an opportunity to: 1) gain access to new research treatments before they are widely available; 2) interact with a team of healthcare professionals with whom they can discuss their medical condition; and 3) and help others by being part of a medical research study. Researchers in clinical trials report their results at scientific meetings, to medical journals, and to the FDA. The names of participants will remain secret and will not be mentioned in these reports. Every clinical trial at Mills-Peninsula Health Services has been approved by an institutional review Board (IRB), which makes sure that the risks of the trial are as low as possible and are worth the potential benefits. An IRB is an independent committee of healthcare professionals and community advocates that oversees a clinical trial and makes sure that the trial is ethical and that the rights of participants are protected.