Wednesday, April 16, 2014

Trial Design for Breakthrough Pain: Is It Ethical to Have a Placebo in a Trial?

 2014 Apr 9. pii: S0149-2918(14)00138-6. doi: 10.1016/j.clinthera.2014.03.005. [Epub ahead of print]

Trial Design for Breakthrough Pain: Is It Ethical to Have a Placebo in a Trial?

Author information

  • 1Cleveland Clinic Lerner School of Medicine, Case Western Reserve University, Cleveland, Ohio; Palliative Medicine and Supportive Oncology Services, Division of Solid Tumor, Taussig Cancer Institute, The Cleveland Clinic, Cleveland, Ohio.
  • 2Department of Palliative Care & Rehabilitation Medicine, F.T. McGraw Chair in the Treatment of Cancer, 1515 Holcombe Boulevard, Unit 1414, Houston, TX 77030.

"It is difficult for us to understand why investigators would knowingly provide placebo and allow patients to experience pain, particularly with the large number of randomized fentanyl trials published have demonstrated benefit.9 This is analogous to treating Stage II breast cancer after local therapy, randomizing individuals to therapy or no therapy when present-day evidence has abundantly established therapeutic benefits for adjuvant breast cancer therapy (though placebo in breakthrough-pain trials does not have the same potential fatal outcome). It is time to change this approach to breakthrough-pain trials of analgesics. Trials of analgesics should at least be consistent with the standard of care and stay within the framework of best practices."

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