Our Initiatives for Diversity in Clinical Trials
At Eisai, our mission is to ensure that our existing human health care (hhc) philosophy which is “Giving first thought to patients and the people in the daily living domain, and increasing the benefits that healthcare provides to them” is reflected in our clinical research. Eisai is committed to maximizing clinical trial access for all patients, regardless of their ethnicity, race, sex, age, socio-economic status, gender identity, geographic location, or physical abilities. As a company, we work to ensure that diversity in clinical trials and health equity is a core commitment across our organization and raise awareness within the pharmaceutical industry.
As a global organization, Eisai encompassing employees from a variety of cultures, ways of life, and experiences, which affords us the advantages of diversity of thought as well as the freedom to express new ideas, all culminating in novel approaches to our science. By creating space to think innovatively, we continue to explore ways to ensure inclusivity and equity of treatment options for all individuals on their healthcare journey. We recognize that a diverse clinical trial population can contribute to a more accurate assessment of a drug’s efficacy and safety profile, and therefore enables our medicines to benefit a wider patient population.
In keeping with recent FDA initiatives, Eisai is committed to reflecting a diverse patient population in our clinical trials to reduce healthcare disparities and enhance health equity. Our approach includes plans to expand access to underrepresented groups in part through review and amendment of protocol designs to mitigate potential barriers to patient recruitment and retention. Eisai has embarked on several initiatives and has begun to partner with patient advocacy groups and organizations that reflect the patients voice and promote change, inclusivity, and equity in healthcare. Additionally, we believe that understanding the patient’s perspective on trial participation and the barriers that they may face is critical to developing meaningful solutions for low patient enrollment, patient withdrawal, and patient recruitment challenges across populations. By identifying clinical trial sites that are geographically accessible to more patients, we can ease patient burden and inherently promote the participation of diverse patient populations in our trials. Furthermore, patient perspectives in our trial designs and protocols are critical to the progress we have made to date; we are also committed to gaining insights from study investigators and other healthcare providers with whom we work to care for patients in our clinical trials. We aim to evolve this practice for process improvements and to ensure that it supports our goal of inclusivity and equity for all patients. The insights and knowledge that we can gain from our partners and patients can provide us with invaluable information to implement changes to advance health equity.
Education and transparency are also essential in diversifying our clinical trial populations and improving access to treatments. Eisai is working with our partners to identify gaps that exist in our communications by developing plain language summaries of our clinical trials, which summarize data in clear and understandable patient-centric manner. Furthermore, Eisai is exploring transcultural resources and partnering with patient advocacy groups to remain steadfast in our goal of meeting the needs of wider populations.
In clinical trial programs for Alzheimer’s disease, recruitment of demographically diverse populations is imperative to the generalizability of results and to ensure representation of all communities affected by dementia. Significant efforts have been made to enhance the recruitment and enrollment of diverse participants in our clinical trials in early Alzheimer’s disease. Eisai achieved the highest representation of racial and ethnic diversity in any Alzheimer’s disease phase 3 clinical trial to date with the Clarity AD study. Some efforts that led to this achievement included but were not limited to selection of sites and investigators who had access to more diverse communities, conducting community outreach in different settings (i.e., community centers, churches) and decentralizing clinical trial activities to reduce burden on participants. Significant innovations in the preclinical Alzheimer’s disease, AHEAD study, for diverse participant recruitment and enrollment are ongoing.
Eisai also recently earned a silver rating in a study assessing diversity in oncology trials (Varma T, Mello M, Ross JS, et al. Metrics, baseline scores, and a tool to improve sponsor performance on clinical trial diversity: retrospective cross sectional study. BMJ Medicine 2023;2:e000395). The study was conducted between 2012 and 2017, and ranked 25 biopharma firms by assessing how many trial participants were women, over 65, part of minority racial and ethnic groups, and how clearly those numbers were reported. This recognition demonstrates our company’s commitment to transparency and our efforts toward achieving diverse representation in our trials. We are committed to evolving the paradigm of clinical trial standards and fostering inclusiveness and equity, and this is just the beginning.
Health equity is not only aspirational; it is imperative. Eisai will continue to explore ways by which we can expand participation in clinical trials and address the disparities that exist through partnering with patients, care partners, advocates, hospitals, institutions, healthcare providers, regulators, and other pharmaceutical companies. Insights and learnings from ongoing efforts such as the Clarity AD trial are being utilized to support future diversity efforts. We pledge to remain focused on health equity for all patients in every community around the globe and build patient trust in the clinical research process. Our ongoing efforts will evolve with the help of our patients, the health care community, and our employees, by promoting accessibility of our medicines to all patients.
This statement can also be found on the Eisai Co., Ltd. Website.
H3 Biomedicine (H3B) was established in December 2010 as a subsidiary of Eisai and began operations in August 2011 in the pursuit of two objectives: to both identify and create innovative therapeutic compounds by focusing on drug discovery and development driven by patient-derived genomic information.
Since then, H3B has been a significant and innovative research and development engine. As we look into the future to discover the next novel therapy, Eisai has decided to realign our global discovery centers and several development functions into a global organization focused on Deep Human Biology Learning (DHBL).
With this shift and upon completion of its objectives, H3B has closed. We are grateful to our H3B colleagues for their significant contributions toward advancing science and proficiency in their key fields of expertise.
Going forward, Eisai will continue to focus on new scientific approaches that create unique and competitive drug discovery and development for which our company is known. Our innovations intersect health and technology to help people predict, prevent and treat serious diseases.
To learn more about Eisai’s precision oncology research and development, please visit Eisai Inc. If you have questions or need assistance regarding H3B, its work or assets, please Contact Us.
