A clinical trial is research conducted in volunteers. These volunteers may be healthy volunteers, or may be volunteers with a specific disease. The process of developing new drugs or devices to combat disease depends upon volunteers taking part to prove their safety and effectiveness. New drugs and devices need to unquestionably demonstrate their safety and effectiveness before the Food and Drug Administration grants approval. Institutional Review Boards are made up of physicians, attorneys, ethicists, clergy and patient advocates which review clinical trials and assess the risks and safety, and determine that they are reasonable in people.
Safety is the most important goal in conducting clinical trials.
Prior to enrollment in a study, a meeting with the patient and their family to review the consent form and discuss any questions related to the plan of treatment and side effects will take place. The consent form is a written summary of the study and the patient's signature is documentation of agreement to participate in the study or treatment plan. The FDA further states that the entire informed consent process involves providing a patient with adequate information concerning the study, providing ample opportunity for the patient to consider all options, responding to the patients questions, ensuring that the patient has understood the information, obtaining voluntary permission to paticipate and, continuing to provide information to the patient as the situation requires. The informed consent process is most effective when there is an open exchange of information and questions between the patient and expert. There may be risks associated with participating on a clinical trial.