Ramping up phase I trial recruitment: Defining potential barriers and disparities

BackgroundIn addition to the structural/medical barriers that trial centres face in including patients, the disparities that patients face prevents some groups from receiving the expected benefit from the studies and the results from representing the entire population. This study assessed the barriers to recruiting individuals in phase one trials who were referred to clinical research facility located in central London.MethodsRecords of patients who were referred to Guy's Cancer Early Phase Trials Unit between January and December 2023 were retrospectively reviewed. Baseline patient characteristics and barriers to trial enrolment were recorded and descriptive statistics were presented. The distrubition of new referrals by age, cancer types, ethnicity, and socioeconomic status defined by Index of Multiple Deprivation (IMD,1 - most deprived; 10 - least deprived) was also assessed by comparing with our group's historic data published in 2013 in Journal of Clinical Oncology.ResultsWe reviewed 206 new patients in 2023. Median age of the group was 63, and 52.4% of patient were male. GI, thoracic, gyneacological and urological malignancies were the most common tumour groups (37%, 19%, 18%, and 14% respectively). Of whole group, 33.9% of patients were referred after two lines of previous treatment. 37 patients (17.9%) were recruited to a trial annually. Most common barrier to be recruited to a trial is that the center has no potential trial to offer (N=59, 35.9%), followed by failure to meet radiological criteria (11.2%), and poor performance status (10.0%) 22 patients (10.6%) were from most deprivated (IMD 1-2) background. Our historic data from 2013 showed 21.9% of patients had been referred from most deprivated background. There was a white-ethnicitiy domination in current and historic data (71.5% and 74.2%, retrospectively).ConclusionsAn increasing number of new patients are being referred to our centre. Among the prominent recruitment barriers are the lack of appropriate studies and non-compliance with medical criteria. The decrease in the rate of patients from low socioeconomic backgrounds is striking compared to the historical data of our center. Further efforts should be made to identify the potential causes of this situation and to improve it.Legal entity responsible for the studyThe authors.FundingHas not received any funding.DisclosureAll authors have declared no conflicts of interest.