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

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.