Written by:
Senior Director, R&D Patient Science, AstraZeneca
Senior Director, Patient Science, AstraZeneca
Chief Safety Officer, AstraZeneca
Senior Director, Clinical Trial Diversity, AstraZeneca
As part of our focus on sustainable science, we want the participants in our clinical trials to represent the people who may one day use our medical interventions. Diversity covers a complex range of factors—race, ethnicity, sex, gender, age, socioeconomic background, and more—that can influence how people react to or use a medicine. The inclusion of diverse participants in clinical trials ensures that the trial populations reflect those affected by the disease who may use the products once approved and is central to understanding how medical interventions affect a variety of patient populations. It also supports the assessment of the impact of different demographic and non-demographic characteristics on the efficacy and safety of medical interventions to ensure that our trial results are generalisable to most patients affected by disease.
As a science-led, patient-focused organisation, we are committed to improving clinical trial diversity, ensuring intrinsic and extrinsic representation so we can better understand how our medicines perform in different populations.
Clinical trial populations should mirror the populations affected by the disease for three key reasons: good science requires studying the medicine in all people affected by disease; it is the right thing to do; and we maintain sustainable business practices by responding to the demands of patients and regulators.
Prioritising diversity in our clinical trials is key to meeting the needs of our patients and regulators — it is also simply ‘good science'
Evaluating new medicines in affected populations isn’t a simple matter of ambition. To realise our ambition, we are taking a systematic approach to embedding diversity in research and development (R&D), focused on three areas that deliver on our commitment and meet unmet patient needs.
- Innovative solutions in clinical trial design and delivery
- Effective clinical trial diversity partnerships
- Data-driven continuous improvement
Innovative solutions in clinical trial design and delivery
Our clinical teams are evolving their ways of working by identifying, designing, piloting, and continuously assessing solutions that advance diversity in our clinical trials.
These solutions span the development lifecycle from input into study design, and new R&D epidemiology models to support the creation of a diversity action plan, dashboard, guidance documents, and social media campaigns in partnership with patient groups. For example, we have standardised how we deliver clinical trial diversity action plans, now required by the Food and Drug Administration (FDA) for Phase III studies, to create consistency and spur measurable progress. Clinical trial diversity is now a core consideration in our feasibility and site selection process, and we are investing in clinical trial site support.
Effective clinical trial diversity partnerships
We understand that engagement with multi-sector stakeholders is required to address historical barriers to achieving diversity among clinical trial participants. We are committed to partnerships with patient communities, industry partners, academic institutions, and regulatory bodies to co-develop innovative clinical trial diversity best practices and solutions, and facilitate knowledge sharing, as a part of our commitment to advance health equity through diversity in clinical trials. Some of our external partners engagement include:
- The establishment of long-term engagements with multiple community health organisations (CHO) to broaden the inclusion of historically underrepresented patient groups in our clinical trials and working with the CHOs to build trust and promote engagement and trial awareness in underserved patient populations.
- As a member company in the Transcelerate Diversity of Clinical Trial Participants working group, we partner with other industry players to develop solutions and resources to improve the representation of diverse patient populations in clinical trials.
- Contribute to the development of clinical trial diversity best practice and guidance as an industry member of working groups including the FDA (US), Medicines and Healthcare products Regulatory Agency (UK), and the Health Research Authority (UK).
Continuous improvement by being data-driven
We prioritise data gathering to capture insights rooted in the real world. These data will guide our clinical development and diversity planning strategies and enable us to systematically track and monitor progress. Evidence-based research is required to better understand barriers to clinical trial participation among different dimensions of diversity, including improved race, ethnicity, and socio-economic diversity strategies.
Most recently, we’ve completed a review of 246 studies (Phase I-III) and 95,372 adult patients (2010–2022) in Oncology, Respiratory & Immunology (R&I), and Cardiovascular, Renal and Metabolism (CVRM) across 57 indications. This analysis reviewed the demographics of enrolled patients in two ways—against the 2019 US Census and per therapy areas. Recently published in Contemporary Clinical Trials, data showed that enrolled patients broadly aligned with the US Census and offer us a measurable foundation to build upon.
At the individual trial level, we have developed a bespoke recruitment dashboard that allows clinical teams to track diverse enrolment in real time, and further tailor our strategies to enrol diverse populations in Phase III studies in the United States.
Our commitment to accelerate clinical trial diversity
Equitable R&D, including equitable participation in trials, is an ongoing journey to embed stronger processes, systems, and standards that remove barriers and improve access to healthcare for all. We are dedicated to eliminating long standing 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 our clinical trials. While we are incredibly proud of our progress to advance Clinical Trial Diversity in recent years, there is much work to be done. We are committed to the journey to address barriers to clinical trial participation and to improve outcomes for all patients.
