Physicians

Abstract

During the conduct of drug or device research, two distinct types of physicians are usually interacting with the patient. One group is primarily responsible for the conduct of the research and consists of the principal investigator (PI) and his associates as well as the several physicians in the sponsoring company. Another group of physicians provides the patient’s ordinary health care in a practice mode and usually has little or no knowledge of the research protocol and its proper execution. The protocol physicians derive benefit from the completion of the protocol and, therefore, are considered to some degree in a conflict of interest with pure advocacy of what is beneficial for the patient (see Spiro, 1986).