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Therapy Testing in a Spheroid-based 3D Cell Culture Model for Head and Neck Squamous Cell Carcinoma
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Published on: April 20, 2018

Redefining reach: inclusivity gaps in UK phase 3 head and neck trial protocols over the last decade

Yuri Hirayama1, Shoba Dawson2, Somiah Siddiq3

  • 1University Hospitals Birmingham NHS Foundation Trust Queen Elizabeth Hospital Birmingham Mindelsohn Way Edgbaston, Birmingham United Kingdom, B15 2TT.

Journal of the National Cancer Institute
|August 19, 2026
PubMed
Abstract

Insights

Head and neck cancer trial protocols often lack inclusivity, failing to represent diverse patient groups. Future trials need stronger adherence to inclusion policies to improve generalizability and equity in cancer research.

Area of Science:

  • Oncology
  • Clinical Trials
  • Health Equity

Background:

  • Inclusivity in head and neck cancer trials is poorly understood, potentially limiting findings' applicability to under-represented populations.
  • Systematic reviews using inclusive frameworks can enhance trial design and delivery for underserved groups.

Purpose of the Study:

  • To systematically review UK-sponsored Phase 3 head and neck cancer trial protocols over the last decade for inclusivity.
  • To assess trial protocols against established equity, diversity, and inclusion (EDI) frameworks.

Main Methods:

  • Phase 3 head and neck cancer trial protocols (July 2014-July 2024) were retrieved from ISRCTN and ClinicalTrials.gov.
  • Protocols were evaluated using the Patient-Reported Outcomes for Equity, Diversity, and Inclusion (PRO-EDI) and NIHR INCLUDE frameworks.
  • Participant characteristics including age, sex, ethnicity, socioeconomic status, education, and disability were collated.

Main Results:

  • Of 14 analyzed protocols, reporting on inclusion characteristics was inconsistent.
  • Most trials (85.7%) had no upper age limit, but only 14.3% referenced ethnicity or socioeconomic status.
  • Few protocols (28.6%) mentioned biological sex, and none addressed health literacy or planned subgroup analyses.

Conclusions:

  • Trial protocols show a significant lack of inclusive considerations, highlighting a gap between policy and practice.
  • Emerging initiatives and mandatory inclusion requirements present opportunities to improve transparency and representation.
  • Strengthening inclusivity in head and neck cancer trials is crucial for equitable research outcomes.

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