AstraZeneca is intensifying its focus on enhancing diversity in clinical trials through data-driven approaches and strategic partnerships. The company is implementing a systematic approach to embed diversity in research and development (R&D), addressing unmet patient needs and striving for equitable healthcare access. These efforts include innovative trial designs, effective partnerships, and continuous improvement through data analysis.
Innovative Solutions in Trial Design and Delivery
AstraZeneca's clinical teams are evolving their methodologies to identify and implement solutions that promote diversity in clinical trials. These solutions span the entire development lifecycle, from study design to the creation of diversity action plans, dashboards, and social media campaigns in collaboration with patient groups. Standardized clinical trial diversity action plans, now mandated by the FDA for Phase III studies, ensure consistency and measurable progress. Clinical trial diversity is a core consideration in feasibility assessments and site selection, supported by investments in clinical trial site support.
Strategic Partnerships for Broadening Inclusion
Recognizing the importance of multi-sector collaboration, AstraZeneca is committed to partnerships with patient communities, industry peers, academic institutions, and regulatory bodies. These collaborations aim to co-develop best practices and solutions for improving diversity in clinical trials and facilitate knowledge sharing. Key partnerships include:
- Long-term engagements with community health organizations (CHOs) to broaden the inclusion of historically underrepresented patient groups.
- Participation in the Transcelerate Diversity of Clinical Trial Participants working group to develop resources and solutions for improving diverse patient representation.
- Contribution to clinical trial diversity best practices and guidance as an industry member of working groups with the FDA (US), MHRA (UK), and HRA (UK).
Data-Driven Continuous Improvement
AstraZeneca prioritizes data gathering to inform clinical development and diversity planning strategies, enabling systematic tracking and monitoring of progress. A recent review of 246 studies (Phase I-III) involving 95,372 adult patients (2010–2022) across Oncology, Respiratory & Immunology (R&I), and Cardiovascular, Renal and Metabolism (CVRM) in 57 indications, published in Contemporary Clinical Trials, indicated that enrolled patients broadly aligned with the 2019 US Census. At the individual trial level, a bespoke recruitment dashboard allows clinical teams to track diverse enrollment in real time and tailor strategies for Phase III studies in the United States.
Commitment to Equitable R&D
AstraZeneca is dedicated to eliminating health disparities and fostering an environment where every individual, regardless of race, ethnicity, sex, gender, age, or socioeconomic background, has equal access to and representation in clinical trials. The company acknowledges that achieving equitable R&D and trial participation is an ongoing journey requiring stronger processes, systems, and standards to remove barriers and improve healthcare access for all.
