The Clinical Protocol A clinical trial consists of an exact written description of a treatment program that is called the clinical protocol. This is formulated and written with great care. Not only do the researchers need to be sure that the trial will answer the two main questions about effectiveness, but the rights of the patients being treated have to be safeguarded too. The risks involved have to be minimized and disclosed.
The clinical protocol outlines the criteria for patients who might participate in the trial. It also describes what tests will be done and how the researchers will determine if a tumor is responding. Systems for monitoring the patient and checking for any adverse effects will be detailed. And there will be provisions for "informed consent."
Who Approves the Trial The entire project has to be approved by a Human Ethics Committee made up of physicians and non-physicians who have no relationship with the study. The members of this committee certify that the patient's rights are protected, that the trial is reasonable and logical and that the study will answer the question it is supposed to answer. These same committees review the studies again during and after completion of the trial as originally proposed. The National Cancer Institute of Canada also keeps watch on these investigational studies.
