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Randomised clinical trials are widely accepted as the gold standard method for clinical development, however, participants have historically not been fully representative of the target population, with women, ethnic minorities, and the elderly being consistently under-represented. We wanted to understand how technology can increase patient-centricity in clinical trials, reduce the burden of trial participation, and increase access to a broader and more diverse pool of patients.

Using the Lightning Insights platform to survey HTA and budget-holding stakeholders in the US, UK, Germany and France, our research programme explored stakeholder perceptions of the barriers to clinical trial diversity, the key implications of a lack of trial diversity on both patients and society, and how technology can enable clinical trial cohorts to be more representative of real-world patient populations.

In this research, stakeholders across key global markets acknowledge that patient cohorts involved in clinical research in oncology often lack diversity. In particular, minority ethnic and racial groups were highlighted as being underrepresented in clinical trials.

Telemedicine and remote consultation with physicians, and the use of electronic health records were consistently valued by all respondents to support the diversity and representativeness of clinical trial enrolment. The KOL respondents noted that these methods were both highly influential and easy to implement.

Respondents indicated that technology can also be used to facilitate the increased representation of all relevant subgroups in clinical trials, supporting the recruitment and enrolment of patients and increasing patient engagement to reduce patient drop-out.

Regulatory requirements can have a role in encouraging sponsors to ensure increased representation in clinical trials however, direct regulations to enforce diversity, such as quotas, may be considered pragmatically challenging and potentially unethical.

To learn more about this recent research and how Lightning Insights was used to inform this poster, contact our expert team.

Article published 8 November 2021.