Early Phase Clinical Trial Designs - State of Play and Adapting for the Future.

JA Harrington, TC Hernandez-Guerrero, B Basu

OAI: oai:www.repository.cam.ac.uk:1810/305652 • DOI: 10.17863/CAM.52730

The process of anti-cancer drug development is complex, with high attrition rates. Factors that may optimise this process include well-constructed and relevant pre-clinical testing and use of biomarkers for patient selection. However, the design of early phase clinical trials will probably play a vital role in both the robust clinical investigation of new targeted therapies and in streamlining drug development. In this overview, we assess current concepts in phase I clinical trials, highlighting issues and opportunities to improve their meaningfulness. The particular challenge of how to design combination trials is addressed, with focus on the potential of new adaptive and model-based designs.

adaptive design biomarker dose escalation methods early phase clinical trials phase I trials Antineoplastic Agents Clinical Trials as Topic Humans Neoplasms Research Design