ABSTRACT
Drug development involves the translation of cutting-edge science into commercial reality by providing concrete healthcare benefits to the community. Demanding as the science is, clinical trials have more problems with management than with science. Indeed, in later-phase trials, the majority of project team members spend far more time on management and administration than they do on science. Over 20 years of training clinical research staff in project management, I have found that most trainees worry vastly more about missing time, cost, and quality targets than they do about unexpected scientific findings. Yet, I sometimes hear experienced people claiming that clinical trials are too unpredictable for detailed project management. My objective is to show that this is not the case. Indeed, the inherent variability and risk of biological systems demand the best project management practices available.
