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Highlighting the need for reliable clinical trials in glioblastoma

Jacob J Mandel1, Michael Youssef1, Ethan Ludmir2

  • 1a Department of Neurology , Baylor College of Medicine , Houston , Texas , USA.

Expert Review of Anticancer Therapy
|July 6, 2018
PubMed
Abstract

Insights

Phase II glioblastoma trials often fail to predict success in phase III studies due to design flaws. Addressing these issues in early-stage glioblastoma research is crucial for discovering effective treatments.

Area of Science:

  • Neuro-oncology
  • Clinical trial design
  • Glioblastoma research

Background:

  • Glioblastoma (GBM) has dismal survival rates, with recent phase III trials failing to improve outcomes.
  • Promising phase II glioblastoma trial data have not translated to phase III success.

Purpose of the Study:

  • To review prior phase II and III glioblastoma studies.
  • To identify limitations in phase II trial design that may explain the failure of subsequent phase III trials.

Main Methods:

  • A literature review of published phase II and phase III glioblastoma studies was conducted.
  • Analysis focused on identifying common issues and discrepancies between phase II and III trial results.

Main Results:

  • Several critical issues were identified in phase II glioblastoma trials, including improper therapeutic selection.
  • Suboptimal phase II designs often lacked control arms, molecular data, and pharmacodynamic testing.
  • The use of imaging criteria as surrogate endpoints in phase II trials was also a concern.

Conclusions:

  • Recognizing and rectifying phase II trial limitations is essential for improving the accuracy of discovering survival-prolonging glioblastoma treatments.
  • Improved phase II study designs are needed to better predict efficacy in phase III glioblastoma trials.
Keywords:
Clinical trialsadaptive trial designglioblastomaphase IIphase III

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