Clinical trials are key to advancing safe and effective treatments for bleeding disorders. They are an important step in the FDA drug-approval process and provide researchers with invaluable data about a drug’s effectiveness and side effects. With the pace of innovation in the bleeding disorders community, it is important for consumers to understand the Clinical Trials process and what their role is should they choose to participate. Some of the topics covered include an overview of the phases of the clinical trials process, informed consent and consumer responsibilities of participation in trials.