Importance of Improving Patient Diversity in Clinical Trials

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Appropriate demographic representation in clinical trials can help ensure that a therapy’s effects, including safety and efficacy outcomes, are understood across various patient characteristics such as race/ethnicity, gender, age, health status, socioeconomic status, and geographic location. Individuals from minority populations have historically been underrepresented in clinical research, often bear a disproportionate disease burden, and many are underserved by the healthcare industry. Increasing the diversity of clinical trial participants has become a goal for many organizations in the biopharmaceutical space; however, improving patient diversity is easier said than done.

The primary intent of this research is to provide perspective on how sponsors and CROs are approaching the topic of patient diversity in clinical trials. ISR surveyed 100 individuals from sponsor organizations and CROs who are involved with developing plans and tactics to improve patient diversity to understand organizational approaches and best practices. ISR also conducted in-depth interviews with 10 of these respondents to gain an even deeper level of understanding.

What you will learn:

• Understand the level of importance placed on patient diversity
• Discover which demographic characteristics are being focused on
• Learn the extent to which companies have trial-by-trial or organization-wide goals for patient diversity
• Understand how organizations track progress toward patient diversity goals and what happens if goals are not met
• Compare differences in findings between large and non-large sponsors

If readers are interested in additional insights on this topic, information in the full report can be used to:

• Gather information on organizational approaches to improving patient diversity, including the use of dedicated staff, dedicated budgets, and reporting structures
• Assess strategies used to improve patient diversity and consider which might be impactful for your trials
• Gain an understanding of the challenges others encounter when working to improve diversity
• Compare your company’s approach to patient diversity to that of other organizations

Respondents were required to pass several screening criteria to qualify and participate in this survey:

• Must work at a biopharmaceutical company, medical device company, or Contract Research Organization (CRO)
• Must be manager level or above
• Must have responsibility in at least one of several relevant areas such as Clinical Operations/Project Management, Executive Management, Medical, Patient Diversity, Patient Recruitment, or Research & Development Management
• Must be “moderately” or “heavily involved” with developing plans/tactics to improve patient diversity in clinical trials