At the 8th Annual Women of Color in Pharma (WOCIP) Conference earlier this month, Clarkston’s Erica Parks Murray connected with dozens of industry experts – from physicians and clinical professionals to scientists and researchers – to discuss the latest trends, challenges, and opportunities driving unity in the life sciences industry. This article reflects her takeaways on ensuring clinical trial diversity and inclusive research.   

One of the key themes that emerged from this year’s 8th Annual WOCIP Conference surrounded the importance of diverse representation in order to achieve health equity. In a session titled “Empowering Inclusive Research: Decoding FDA’s Diversity Action Plan Guidance & Applying ICER’s Measurement Framework,” Foluso Agboola and Neali Lucas, Ph.D. discussed the importance of including diverse participants in clinical trials to promote health equity and build confidence in the safety and effectiveness of medical products.  

Clinical Trial Diversity 

The FDA has a long-standing commitment to clinical trial diversity, as evidenced by various initiatives and guidance documents. By prioritizing diversity in clinical trials, we can ensure that medical products are safe and effective for all populations, regardless of race, ethnicity, sex, age, or socioeconomic status. Lucas talked about key challenges that include limited data availability, global trial complexities, and socioeconomic disparities. To address these challenges, the speakers emphasized the need for proactive planning, diverse workforce, community engagement, and transparent data reporting, such as through the Drug Trial Snapshots initiative.  

Agboola’s presentation also discussed the critical role of clinical trial diversity in ensuring equitable access to innovative therapies. The Institute for Clinical and Economic Review (ICER), a leading healthcare research institute, has taken significant steps to incorporate the evaluation of clinical trial diversity into its assessment of new treatments.  

Clinical trial diversity is essential for several reasons: 

• Public Trust: A lack of diversity in clinical trials can erode public trust in medical research. It raises concerns about whether the benefits and risks of a treatment have been adequately assessed for all populations. 
• Fairness: Excluding certain groups from clinical trials can perpetuate health disparities. It is crucial to ensure that all patients have equal access to innovative therapies. 
• Generalizability of Results: Diverse clinical trials are more likely to produce results that are applicable to a broader population. This helps to identify potential differences in treatment response based on factors like race, ethnicity, sex, and age. 

How ICER Analyzes Clinical Trial Diversity 

Agboola continued, covering the importance of clinical trial diversity and ICER’s role in evaluating it. ICER assesses the value of new therapies, including their cost-effectiveness and potential benefits. By analyzing the benefits and risks of these therapies, the organization provides valuable insights to policymakers, payers, and patients. Additionally, by analyzing the representation of various demographic groups in clinical trials, ICER aims to identify disparities and promote more inclusive research practices.  

To ensure equitable access to treatments, ICER has developed a framework to evaluate clinical trial diversity. This framework considers the following factors: 

• Race and Ethnicity: The representation of different racial and ethnic groups in clinical trials. 
• Sex: The inclusion of both male and female participants. 
• Age: The representation of different age groups, particularly older adults. 

To evaluate the diversity of a clinical trial, ICER calculates a participation-to-disease ratio (PDR) for each demographic group. The PDR compares the proportion of participants from a specific group in the trial to their prevalence in the target population. By analyzing these ratios, ICER can identify disparities and assess the adequacy of representation.  

Agboola also emphasized the need for transparency and accountability in clinical trial diversity, calling on pharmaceutical companies to prioritize equitable representation in their studies.  

Challenges and Opportunities 

While ICER’s framework represents a significant step forward, there are several challenges to address: 

• Data Limitations: Limited data availability, particularly for certain demographic groups, can hinder the accurate assessment of clinical trial diversity. 
• Global Trials: Evaluating the diversity of multinational trials can be complex, as different countries have varying demographic profiles. 
• Socioeconomic Status: While race, ethnicity, sex, and age are important factors to consider, socioeconomic status can also significantly impact health outcomes and access to care. 

Despite these challenges, there are opportunities to improve clinical trial diversity: 

• Regulatory Oversight: Regulatory agencies, such as the FDA, can play a crucial role in promoting diversity in clinical trials by establishing guidelines and enforcing compliance. 
• Industry Collaboration: Pharmaceutical companies can work with patient advocacy groups and academic institutions to develop more inclusive clinical trial designs. 
• Public Awareness: Raising public awareness about the importance of clinical trial diversity can encourage individuals from underrepresented groups to participate in research. 

By addressing these challenges and seizing these opportunities, we can work towards a future where clinical trials are truly representative of the populations they serve. 

Looking Ahead 

Lucas and Agboola agreed to connect and continue the conversation with a goal to determine where there are synergies that can benefit the FDA and ICER, and, ultimately, the patients that live in the communities in which they serve. 

To continue the conversation with a Clarkston expert, click here.