In general all research studies are designed to minimize the risk to the volunteers participating in the clinical trial. Most drug studies start evaluating the safety of the drug at the lowest dose and only move onto higher doses once a lower dose is found to be safe. During the trial, medical exams, office visits, laboratory and diagnostic test are unitized to monitor individuals safety and wellbeing while they are in a clinical trial.
It is important that you see your study doctor at every trial visit and let them know if you are experiencing any side effects from the investigational treatment. In my opinion, there are risks to any new treatment; however, if you have an informed volunteer with an experienced physician and a trial team, the study process works and the benefits out way the risks for most study participants.
Remember, as a study participant you can withdrawal or discontinue your study participation at any time for any reason without penalty or prejudice.
Thank you for following this series of articles. My goal is for you to be informed and have more knowledge about clinical trials. Don’t miss next week topic on study drug versus placebo.
-Dr. Howard Schwartz M.D. – Gastroenterologist
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