The Use of Total Quality Management Principles in Placing and Monitoring Clinical Trials

Abstract

The use of total quality management (TQM) techniques has become widespread in many areas of industry and service. These techniques should be used in clinical trials also. This paper addresses the use of these methods in placing and monitoring clinical trials. Viewing the investigator as a vendor or supplier (of data) who should share the sponsor's interests is recommended. This view leads to changes in the way investigators are chosen, trained, retrained, and treated by the sponsor. It is believed that the changes will have mutual advantages—the investigator will have a more stable, secure, and long-term relationship and the sponsor will enjoy lower internal and external costs, and more timely and accurate data.