OBJECTIVES:

Historically, participants of clinical trials have not been representative of the target patient pool, with women, ethnic minorities, and the elderly being consistently under-represented. This lack of diversity in clinical research can have significant impacts on understanding the effectiveness and safety of a treatment, with more frequent adverse effects occurring in under-represented groups. Barriers to patient participation include medical mistrust, eligibility requirements, and lack of access. This research aims to explore how advances in technology can increase patient centricity in trials, reduce burden of trial participation, and increase access to a broader and more diverse pool of patients.

METHODS:

A primary research programme was conducted with payer and HTA stakeholders, alongside KOLs in the US, UK and Germany, to explore their perceptions of the barriers to clinical trial diversity, with a focus on oncology, and how technology can increase representation within trials. Stakeholders provided insights on the key implications of a lack of trial diversity on patients and society, and how increasing digitilisation of clinical landscapes can address these issues.

RESULTS:

KOLs rated medical mistrust and lack of access to trials as key barriers to recruiting a diverse trial population and acknowledged that the inclusion of certain sub-groups of patients can increase risks. Payers would value measures to increase the representation of real-world patient types within clinical development programmes. Across markets, the increased use of digital technologies was considered a valuable strategy to address these issues, alongside flexibility in trial design.

CONCLUSIONS:

Stakeholders across key global markets acknowledge the that a lack of diversity in clinical research can have major scientific, medical, and moral implications. By developing strategies that utilise advances in technology to reduce barriers to patient enrollment, the diversity of clinical trials can be increased, improving access to new medicines across all socio-demographics.