How is the safety of the patient protected?
The ethical and legal codes that govern medical practice also apply to clinical trials. In addition, most clinical research is federally regulated with built in safeguards to protect the participants. The trial follows a carefully controlled protocol, a study plan which details what researchers will do in the study. As a clinical trial progresses, researchers report the results of the trial at scientific meetings, to medical journals, and to various government agencies. Individual participants’ names will remain secret and will not be mentioned in these reports (See Confidentiality Regarding Trial Participants).
Clinical trials must comply with a wide range of strict rules before they are allowed to go ahead. The most important of these rules are to do with patient safety. The study protocol is laid down before the start of the study and spells out exactly what will be done in the study, how it will be done, and why each part of the study is necessary. The same protocol is used by every doctor or research centre taking part in the trial. The patient is protected by careful adherence to the protocol as well as by close monitoring and reporting of all serious adverse events to the investigators.
