Newsletters

Fall 2006

Why Volunteer for a Clinical Research Trial?

Part II of a II Part Series (Read Part I)

How Will Your Trial be Safeguarded?

Clinical trials are federally regulated with safeguards to protect the participant. The trials follow a carefully controlled protocol, which details the study plan. The protocol describes a participant’s required profile, medical procedures involved, medications, dosages and duration of the study. Participants are seen regularly by the research staff to monitor their health and determine the safety and effectiveness of the treatment.

How is a Participant Chosen for a Study?

All clinical trials have guidelines allowing or disallowing a participant to qualify for a study. The criteria are based on age, gender, type of disease, previous treatment history, existing medical conditions and any medications currently being taken. It is important to note that the inclusion and exclusion criteria are not used to reject people personally. Instead, the guidelines are used to identify appropriate participants, ensure safety during the trial, and provide the researchers accurate data to answer the question they plan to study.

Are There Risks in a Clinical Trial?

There are risks involved in participating in clinical trials. The experimental treatment may not be effective for the participant. Serious or even life threatening side effects could occur. Side effects are any undesired action or effects of the experimental drug. The risks and potential benefits are explained in a consent form, a document detailing the facts about the trial. Our research staff will explain the specific details of each trial. The participant must read and decide whether or not to be part of the study. The consent form is not a contract and the participant may withdraw from the trial at anytime.