Speeding up the evaluation of new agents in cancer

Ann Marie Swart, Mahesh K B Parmar, Friederike M-S Barthel, Matthew Sydes, Ruth Langley, Rick Kaplan, Elizabeth Eisenhauer, Mark Brady, Nicholas James, Michael A Bookman, Wendi Qian, Patrick Royston

Research output: Contribution to journalArticle

95 Citations (Scopus)

Abstract

Despite both the increase in basic biologic knowledge and the fact that many new agents have reached various stages of development during the last 10 years, the number of new treatments that have been approved for patients has not increased as expected. We propose the multi-arm, multi-stage trial design as a way to evaluate treatments faster and more efficiently than current standard trial designs. By using intermediate outcomes and testing a number of new agents (and combinations) simultaneously, the new design requires fewer patients. Three trials using this methodology are presented.
Original languageEnglish
Pages (from-to)1204-1214
Number of pages11
JournalJournal of the National Cancer Institute
Volume100
Issue number17
DOIs
Publication statusPublished - 3 Sep 2008

Keywords

  • United States
  • Randomized Controlled Trials as Topic
  • Disease-Free Survival
  • Ovarian Neoplasms
  • Clinical Trials, Phase II as Topic
  • Antineoplastic Agents
  • Clinical Trials, Phase III as Topic
  • Humans
  • Clinical Trials as Topic
  • Research Design
  • Antibodies, Monoclonal
  • Neoplasms
  • United States Food and Drug Administration
  • Drug Approval
  • Treatment Outcome
  • Organoplatinum Compounds
  • Sample Size
  • Antibodies, Monoclonal, Humanized
  • Time Factors
  • Prostatic Neoplasms
  • Female
  • Male
  • Survival Analysis

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