The prevalence of Alzheimer’s disease (AD) is projected to increase across the world, affecting millions of people living with AD (PLWA) and their families. The majority of PLWA live in low- and middle-income countries, despite current measurements likely underestimating the true prevalence in these regions. Within high-income countries, some ethnic minority groups are reported to be at greater risk of AD. For example, in the United States, Latino and Black Americans will make up nearly 40% of all AD diagnoses by 2030.
Despite the global demographics of AD, the participants in AD clinical trials are predominantly recruited from high-income countries and often do not reflect the diversity of PLWA either globally or from within those countries. Factors such as sex/gender, race, ethnicity, or medical comorbidities can impact the safety and efficacy data obtained in clinical trials, underscoring the need for ensuring that the study population enrolled in the trial is as representative as possible. Consequently, it is crucial that all research in AD focuses on achieving diversity, equity, and inclusion (DE&I) when conducting clinical trials.
Roche has previously worked with international patient groups to develop recommendations for best practice in conducting clinical trials in AD, which were published in the report Integrating the perspectives of people living with Alzheimer’s disease and their study partners into clinical trial development. Although the recommendations contained in the report served to guide our AD clinical trials strategy in the short term, we recognized that further improvements to the way AD clinical trials are conducted, particularly in relation to DE&I, was both possible and needed.
Roche has since conducted research to further understand both the need and the challenges when aspiring for greater DE&I in AD clinical trials. We recognized that we could only truly understand the environment and thereby create tangible aspirations by working in collaboration with patient organizations, academics, and clinicians. This report contains the results of that external validation process and outlines aspirations for the field of DE&I in AD, as well as the steps we believe are required to achieve them.
It is essential that DE&I forms a central pillar of AD clinical research both now and in the future, and we hope the aspirations in this report will be embraced by other organizations involved in AD clinical trials. A lot of these recommendations are disease area agnostic and can likely be used as guidance for other disease area trials.