The Appropriately Designed TDM Clinical Trial: Endpoints, Pitfalls, and Perspectives

Therapeutic Drug Monitoring, vol. 45, pp. 6–10

Abstract

BACKGROUND: Appropriately designed clinical trials can provide the evidence needed to broadly implement therapeutic drug monitoring (TDM). In the past 30 years, some stunning successes but also some fascinating failures in demonstrating the benefits of TDM have been observed. Future TDM studies can be designed based on this experience. METHODS: The manuscript is based on a combination of personal experience and published articles and discusses several aspects of the design and conduct of TDM studies. RESULTS: Recommendations are provided to reduce the risk of protocol violations and to maximize the potential impact of a TDM study on clinical practice. CONCLUSIONS: There are lessons that can be learned from previous experience, and this article gives an overview of potential TDM study designs, endpoints, pitfalls, and perspectives.

Authors 1

1. Teun van Gelder corresponding Aachen Department of Clinical Pharmacy and Toxicology

   Leiden University Medical Center

   Affiliation as printed

   Department of Clinical Pharmacy and Toxicology, Leiden University Medical Center, Leiden, The Netherlands