Better Decisions for Phase 1 Clinical Trials Using Integrated Design Models
Summary: There is considerable pressure to increase the success rate and to address inefficiencies in clinical research in order to reduce the cost of development and strengthen the drug pipeline, yet at the same time, new molecules are presenting more and more challenges that make such improvements difficult. Innovative “adaptive” clinical trial designs utilizing “manufacturing on demand” have emerged as a promising solution to improve speed and efficiency of the drug development process, but these need to be selected carefully, for example, when there is also the need for enabling technologies to resolve bioavailability limitations. Innovative trial designs, on-demand manufacturing, real-time clinical data-based dose adjustments, and partnering with experienced formulators and Contract Research Organizations (CROs) can enable faster, better decision making during phase 1 clinical trials.