Looking ahead in early-phase trial design to improve the drug development process: examples in oncology.

Alyssa M Vanderbeek^1,2, Robert A Redd¹, Steffen Ventz³, Lorenzo Trippa^4,5

¹Department of Data Science, Dana-Farber Cancer Institute, 450 Brookline Avenue, Boston, MA, 02115, USA.

²Unlearn.AI, San Francisco, CA, USA.

³Division of Biostatistics, University of Minnesota, Minneapolis, MN, USA.

⁴Department of Data Science, Dana-Farber Cancer Institute, 450 Brookline Avenue, Boston, MA, 02115, USA. ltrippa@jimmy.harvard.edu.

⁵Harvard T.H. Chan School of Public Health, Boston, MA, USA. ltrippa@jimmy.harvard.edu.

PubMed PMC DOI PDF

Abstract

BACKGROUND: Clinical trial design must consider the specific resource constraints and overall goals of the drug development process (DDP); for example, in designing a phase I trial to evaluate the safety of a drug and recommend a dose for a subsequent phase II trial. Here, we focus on design considerations that involve the sequence of clinical trials, from early phase I to late phase III, that con…

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