Inclusivity of patients in early phase breast cancer clinical trials

Introduction: Studies have shown that certain groups of patients are underrepresented in clinical trials including non-Caucasian ethnicity, poor fluency in English, low socioeconomic status, older age, neurodivergence, and large Body Mass Index (BMI). There is a need to ensure adequate representation of these groups so that the results of any trial accurately reflect the population. The aim of this study was to review the pathway of patients recruited into two early phase breast cancer clinical and determine the inclusivity of patients from the aforementioned sub-groups.

Methods: The Breast Cancer Research Database was reviewed, and the characteristics of all patients who were screened for eligibility in two early phase clinical trials was examined. The English Indices of Deprivation was used to populate the Index of Multiple Deprivation (IMD) for each patient using their postcode.

Results: In total, 392 patients were eligible to participate, between September 2020 to May 2023. Of these, 144 (36.7 %) were recruited to these two trials. In all, 100 % of patients eligible for these trials were approached and screened for participation. Eligible patients had a mean age of 53.5 years. Recruited patients were younger on average than those not recruited (49.1 years vs 56.0 years, p<0.0001). Only one recruited patient required an interpreter, compared with 24 (9.7 %%) of those who were not recruited (p<0.001). There was no difference in the IMD (p=0.38), BMI (p=0.34) and neurodiversity (p=0.10) between patients recruited into clinical trials and those who were not.

Conclusion: Older age and poor fluency in the English language remain barriers to participation in early-phase clinical trials despite implementing a clear pathway to trial recruitment. There is a pressing need to address these barriers by raising awareness, improve appropriate training and providing comprehensive trial information to patients in the language of their choice.