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<p>Clinical trials are at the core of evidence-based medicine, but many are underpowered and fail to inform clinical practice. In mental health, the number of regulatory drug approvals has consistently lagged behind other areas of medicine, the effects of established therapies may vary, and comparative effectiveness data for available treatments are scarce. Thus, there is an urgent need for more efficient, faster and more collaborative ways of generating evidence. Traditional approaches of ‘one treatment, one trial’ are slow, inefficient, and limit comparability across trials. In contrast, platform trials use a shared infrastructure for many treatments, shared control group(s) and a master protocol that allows treatments to be added over time and ineffective ones to be dropped early. Here we present examples of platform trials in mental health (M-PACT, EU-PEARLDIVER, PUMA and RESiLIENT) and discuss their potential to increase speed, reduce operational costs and participant burden, and improve statistical power and comparability.</p>

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Transforming the evidence landscape in mental health with platform trials

  • 期刊论文

  • 发表日期：

    2025年3月10日

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  • Stefan M. Gold,
  • Fanni-Laura Mäntylä,
  • Kim Donoghue,
  • Jelena Brasanac,
  • Michaela Maria Freitag,
  • Franz König,
  • Martin Posch,
  • J. Antoni Ramos-Quiroga,
  • Francesco Benedetti,
  • Ole Köhler-Forsberg,
  • Nina Grootendorst,
  • Witte Hoogendijk,
  • Carmine M. Pariante,
  • Elyse R. Katz,
  • Steve Webb,
  • Belinda Lennox,
  • Toshi A. Furukawa,
  • Christian Otte

摘要

Clinical trials are at the core of evidence-based medicine, but many are underpowered and fail to inform clinical practice. In mental health, the number of regulatory drug approvals has consistently lagged behind other areas of medicine, the effects of established therapies may vary, and comparative effectiveness data for available treatments are scarce. Thus, there is an urgent need for more efficient, faster and more collaborative ways of generating evidence. Traditional approaches of ‘one treatment, one trial’ are slow, inefficient, and limit comparability across trials. In contrast, platform trials use a shared infrastructure for many treatments, shared control group(s) and a master protocol that allows treatments to be added over time and ineffective ones to be dropped early. Here we present examples of platform trials in mental health (M-PACT, EU-PEARLDIVER, PUMA and RESiLIENT) and discuss their potential to increase speed, reduce operational costs and participant burden, and improve statistical power and comparability.