Redefining reach: inclusivity gaps in UK phase 3 head and neck trial protocols over the last decade
Yuri Hirayama, Shoba Dawson, Somiah SiddiqAbstract
Aim
Inclusivity within head and neck cancer trials remains poorly characterised potentially limiting the applicability and validity of findings to under-represented groups. Using inclusive frameworks that enhance trial design and delivery for under-served groups we conducted a systematic review of Phase 3 UK-sponsored Head and Heck trial protocols over the last decade.
Methods
Head and Neck Phase 3 trial protocols registered between July 2014 to July 2024 were retrieved from the ISRCTN and ClinicalTrials.gov registries. Trial protocols were assessed using PRO-EDI (Patient-Reported Outcomes for Equity, Diversity, and Inclusion) and the NHIR INCLUDE framework, and findings summarized narratively. Participant characteristics collated included age, sex, race/ethnicity, socioeconomic status, education and disability.
Results
A total of 2,157 trial protocols were identified (2,029 ISRCTN and 128 Clinicaltrials.gov) and screened. Fourteen trial protocols met inclusion criteria for final analysis. Reporting of inclusion-related characteristics was inconsistent. Most trials (85.7%) imposed no upper age limit. Only 14.3% of trial protocols referenced ethnicity or socioeconomic status, and 28.6% mandated English proficiency without translation support. Only 28.6% trial protocols explicitly mention biological sex. None documented health literacy considerations or planned subgroup analyses.
Conclusion
Overall, trial protocols demonstrated lack of inclusive considerations, underscoring the continued gap between policy and practice. The recently published NIHR’s mandatory inclusion requirements, evolving standards in journal-led inclusive reporting in research trials and emerging initiatives akin to START-EDI, present opportunities to strengthen transparency, accountability and enhance representation in future head and neck cancer trials.