Clinical Research

What is a clinical trial?
A clinical trial is a research study that is conducted in a medical setting such as a clinic or hospital. It usually involves the testing of a new medication, treatment, or device that is not yet approved by the Food & Drug Administration (FDA) for routine use. Clinical trials can also explore new indications for drugs or treatments that are already FDA-approved and are carried out under strict guidelines with great attention to measures of safety. The purpose of a clinical trial is to obtain data regarding the safety and effectiveness of the medication or treatment for the use in which it is being tested. All medications and treatments in use today were first tested in a clinical trial.

For more information on clinical trials, please visit ClinicalTrials.gov

How to enroll in a trial and what to expect? 
The clinical trial investigators usually obtain permission from a volunteer's primary physician before a volunteer is enrolled. The investigators may interact with primary doctors but they do not replace them. Each volunteer is encouraged to maintain close communication with their primary physician regarding all aspects of the clinical trial. An interested volunteer is contacted by the research coordinator and a preliminary screening visit is scheduled to discuss the details of the study with the potential volunteer and determine if he/she is eligible to participate. The nurse or physician will explain the study and the procedures the volunteer will need to follow and answer any questions. This process is called informed consent and is essential before any volunteer is enrolled in any clinical trial. In addition, a full medical history is obtained and a physical exam and lab testing is done to make sure there are no contraindications for participation in the clinical trial. All clinical trials require a time commitment and study schedules vary depending on the individual study. 

What are the rights of a clinical trial volunteer? 
Participation in any clinical trial is voluntary. If you feel any pressure to volunteer for a clinical trial, you probably should not enroll. Volunteers can change their minds and withdraw from the study at any time. Any information obtained in a clinical trial remains confidential and is not shared unless authorized by the participant.