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

Clin Oncol (R Coll Radiol)

Department of Oncology, University of Cambridge, Cambridge, UK; Cambridge University Hospitals NHS Foundation Trust, Addenbrooke's Hospital, Cambridge, UK. Electronic address:

Published: December 2017

AI Article Synopsis

  • The development of anti-cancer drugs is complicated and often fails at high rates, but can be improved with better pre-clinical testing and patient selection using biomarkers.
  • The design of early phase clinical trials is crucial for effectively testing new targeted therapies and making the drug development process more efficient.
  • This overview examines current phase I clinical trial concepts, emphasizing the importance of adaptive and model-based designs for combination trials.

Article Abstract

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.

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Source
http://dx.doi.org/10.1016/j.clon.2017.10.005DOI Listing

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