PROMs: 3 reasons they're failing scrutiny, and how to fix it · The Monday Briefing, 14 September 2026

September 14, 2026  ·  Weekly Newsletter

Good morning, Reader.

The push for patient-centric drug development has made patient-reported outcome measures (PROMs) central to drug approval, yet many fail regulatory scrutiny. This week, we examine why these measures, intended to capture the patient voice, often fall short of the psychometric rigour now expected. It matters.

1. **PROMs lack rigour**, Regulators expect PROMs to show statistical significance and clinical meaningfulness. Many PROMs, particularly older ones, simply do not meet this elevated bar. 2. **Early allergen introduction stalls**, Updated guidelines recommend early allergen introduction for food allergies. But clinical practice uptake remains slow, leaving children vulnerable. 3. **Biosimilar switching is safe**, Biosimilar switching studies consistently show no significant differences in efficacy or immunogenicity compared to reference biologics. That gap is closing.

This week's content highlights a tension: the desire for patient-centric care often outpaces the tools available to measure it reliably. Still, when evidence is clear, like with biosimilar switching, adoption moves faster. The problem is often not the science, but the implementation.

Clinicians must question the tools they use to assess patient experience, even as they embrace established evidence when it arrives.

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Patient Reported Outcomes

The shift towards patient-centric drug development has elevated patient-reported outcome measures (PROMs) from supplementary data to endpoints that determine drug approval. Regulators now expect PROMs to demonstrate not just statistical significance, but also robust psychometric properties and clinical meaningfulness. This elevated bar means many PROMs, particularly those developed without rigorous methodology, are simply not fit for purpose.