Current and Emerging Technologies to Address the Placebo Response Challenge in CNS Clinical Trials: Promise, Pitfalls, and Pathways Forward

William P. Horan, Gary Sachs, Dawn I. Velligan, Michael Davis, Richard S.E. Keefe, Ni A. Khin, Florence Butlen-Ducuing, Philip D. Harvey

Research output: Contribution to journalReview articlepeer-review

Abstract

Excessive placebo response rates have long been a major challenge for central nervous system (CNS) drug discovery. As CNS trials progressively shift toward digitalization, decentralization, and novel remote assessment approaches, questions are emerging about whether innovative technologies can help mitigate the placebo response. This article begins with a conceptual framework for understanding placebo response. We then critically evaluate the potential of a range of innovative technologies and associated research designs that might help mitigate the placebo response and enhance detection of treatment signals. These include technologies developed to directly address placebo response; technology-based approaches focused on recruitment, retention, and data collection with potential relevance to placebo response; and novel remote digital phenotyping technologies. Finally, we describe key scientific and regulatory considerations when evaluating and selecting innovative strategies to mitigate placebo response. While a range of technological innovations shows potential for helping to address the placebo response in CNS trials, much work remains to carefully evaluate their risks and benefits.

Original languageEnglish (US)
Pages (from-to)19-30
Number of pages12
JournalInnovations in Clinical Neuroscience
Volume21
Issue number1-3
StatePublished - Jan 1 2024

Keywords

  • clinical trials
  • ecological momentary assessment
  • Placebo response
  • regulatory
  • remote assessment
  • technology

ASJC Scopus subject areas

  • Clinical Neurology
  • Psychiatry and Mental health

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