Issues in Monitoring Oncology Trials.

The role of the medical monitor has become increasingly important as oncology clinical trials have grown in complexity. Issues in medical monitoring and proposed approaches to improve monitoring, make trials less expensive, and possibly shorten timelines are discussed. This commentary reviews the role of the medical monitor in oncology clinical research. The complexity of the malignant process and the multiple immunotherapeutic, hormonal, cytotoxic, and targeted therapies currently available and in development require an understanding of the biology of both cancer and its systemic treatments. In addition, the amount of data collected requires better methods for data collection and for the early identification of trends, especially in Phase I and II trials. An approach to improved data collection and monitoring methodology that would allow the early identification of safety and efficacy signals is proposed.