By Allison Proffitt 

December 3, 2024 | At the SCOPE Europe conference held in Barcelona in October, clinical trials leaders highlighted transformative shifts toward diversity, inclusion, and patient engagement in study designs. Liz Bristow, director of patient recruitment and retention at AstraZeneca, and Jodie Allen, global senior director of clinical trial diversity at AstraZeneca UK, outlined key advancements and persistent challenges in achieving equitable patient representation across clinical trials.  

They emphasized a patient-centered approach, underscoring that representative studies are crucial for ethical and scientific reasons. It’s essential, they said, to have a clear understanding of the Intended Use Population (IUP) in early stages of clinical planning.  

They found teams were doing their epidemiology work before Phase 3 as they developed their diversity action plans. “It’s too late!” she objected. “You shouldn’t be learning about the distribution of your population when you’re writing your Phase 3 protocol.”  

Allen recounted AstraZeneca's systematic focus on developing diversity action plans that consider specific demographic hurdles early in the trial process. A case in point involved an AstraZeneca-led chronic kidney disease (CKD) trial. When initial data showed high screen-failure rates among Black men due to BMI and blood pressure criteria, the protocol was adapted to be more inclusive. The changes allowed the trial to meet diversity goals, demonstrating how nuanced adjustments in trial criteria can lead to more representative patient involvement. 

In the United States, where the study is recruiting, “It’s made a very significant difference in terms of the Black participants that we have in this study, the Native Americans, the Pacific Islanders,” Allen said.  

Bristow expanded on the importance of cross-functional collaboration, emphasizing that diversity is an organizational responsibility rather than an isolated task. The AstraZeneca team’s efforts focused on integrating diversity action plans into all stages of the trial pipeline, from site selection to community outreach. These steps, she explained, are crucial for addressing structural barriers and understanding the unique needs of underrepresented groups. 

She also advocated for collaboration between sites and sponsors. Sites often felt sponsors simply chased numbers or metrics instead of collaborating on solutions. AstraZeneca introduced a comprehensive dashboard tracking diversity metrics across Phase III trials. Bristow noted that this tool allows for immediate adjustments based on trial progress, making diversity more achievable through ongoing monitoring. 

Despite these advances, Allen and Bristow acknowledged organizational hesitancy in setting specific recruitment goals. Many teams feared regulatory repercussions if diversity targets weren’t met. To address this, AstraZeneca restructured its process by involving clinical teams earlier in defining epidemiological goals, increasing transparency and accountability. 

Reflection is the final, key step in improving diversity, Bristow said. Ongoing commitment and flexibility, though challenging, are essential to building trust with diverse patient populations as well as sites. Continuously reflect, they challenged sponsors, and embed learnings to drive change.  

“We’re supporting 100 Phase 3 teams in the last 18 months,” Bristow said. “The more self-reflective, self-sufficient those teams are, the better we can progress.”  

But Bristow called for diversity and inclusion conversations to start far before Phase 3. “Honestly, this is all very late,” she said, candidly. “We’re starting to think… it really starts at the bench. So we’re starting to engage with our early and discovery teams.”