Accelerating anticancer drug development - opportunities and trade-offs.


Journal Article (Review)

The traditional approach to drug development in oncology, with discrete phases of clinical testing, is becoming untenable owing to expansion of the precision medicine paradigm, whereby patients are stratified into multiple subgroups according to the underlying cancer biology. Seamless approaches to drug development in oncology hold great promise of accelerating the accessibility of novel therapeutic agents to the public but are also accompanied by important trade-offs, including the limited availability of information on the clinical benefit and safety of novel agents at the time of market entry. In this Perspectives article, we describe several opportunities, in the form of novel trial designs or modelling strategies, to improve the efficiency of drug development in oncology, as well as new mechanisms to obtain information about anticancer therapies throughout their life cycle, such as innovative functional imaging techniques or the use of real-world clinical data.

Full Text

Cited Authors

  • Nass, SJ; Rothenberg, ML; Pentz, R; Hricak, H; Abernethy, A; Anderson, K; Gee, AW; Harvey, RD; Piantadosi, S; Bertagnolli, MM; Schrag, D; Schilsky, RL

Published Date

  • December 2018

Published In

Volume / Issue

  • 15 / 12

Start / End Page

  • 777 - 786

PubMed ID

  • 30275514

Pubmed Central ID

  • 30275514

Electronic International Standard Serial Number (EISSN)

  • 1759-4782

International Standard Serial Number (ISSN)

  • 1759-4774

Digital Object Identifier (DOI)

  • 10.1038/s41571-018-0102-3


  • eng