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February 28, 2008Journal of Clinical Oncology2,262 citationsOpen Access

Design and End Points of Clinical Trials for Patients With Progressive Prostate Cancer and Castrate Levels of Testosterone: Recommendations of the Prostate Cancer Clinical Trials Working Group

HSHoward I. ScherSHSusan HalabiITIan F. Tannock

Key Points

  • The aim is to recommend suitable end points for clinical trials focusing on patients with progressive prostate cancer and low testosterone levels.
  • PCWG2 emphasizes the importance of time-to-event end points such as failure to progress.
  • Recommendations are based on data from phase II and phase III clinical trials.
  • Increased focus on time-to-event end points may improve decision-making in trial progression.
  • Future recommendations will be shaped by ongoing data regarding the predictive ability of intermediate end points.

Abstract

PCWG2 recommends increasing emphasis on time-to-event end points (ie, failure to progress) as decision aids in proceeding from phase II to phase III trials. Recommendations will evolve as data are generated on the utility of intermediate end points to predict clinical benefit.

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Cite This Study

Scher et al. (2008) studied this question.

synapsesocial.com/papers/69d981f2387cf70698684632https://doi.org/10.1200/jco.2007.12.4487
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