Dangers of "confirmatory" cancer trials that fail to actually test the original hypothesis

Curr Oncol Rep. 2014 Apr;16(4):381. doi: 10.1007/s11912-014-0381-5.

Abstract

The concept of "confirmatory" studies is a standard and important component of the overall clinical trials strategy in oncology. However, it is critical that such studies are similar enough in basic design and how they are conducted that they actually have the realistic potential to confirm, or refute, objectively the findings of the original study. In this commentary, two examples of clinical studies in the gynecologic oncology arena suggested by some to serve as "confirmatory" trials for the original reports demonstrate both the dangers and potential inappropriateness of such conclusions.

MeSH terms

  • Antineoplastic Agents / therapeutic use
  • Disease-Free Survival
  • Female
  • Humans
  • Ovarian Neoplasms / drug therapy
  • Randomized Controlled Trials as Topic / standards*
  • Research Design / standards*

Substances

  • Antineoplastic Agents