Our Initiatives for Improving Clinical Trial Access and Engagement for All Patients
At Eisai, our mission is to ensure that our 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 improving clinical trial access for all eligible, appropriate patients. Guided by science, our clinical trials assess whether our investigational medicines are safe and effective across various demographics, and we work to ensure broad representation of all patient types.
As a global organization, Eisai is made up of employees who bring a variety of life experiences, training backgrounds and perspectives. This affords us the advantage of different viewpoints as well as the freedom to express new ideas, all culminating in novel approaches to our science. By creating an environment to think innovatively and encourage collaboration, we continue to advance ways to ensure that the medicines we develop can benefit all patients who are affected by a targeted disease.
We recognize clinical trials that reflect real-world demographics enable a more accurate understanding of a drug’s efficacy and safety profile, and Eisai is committed to reflecting a well-defined patient population in our trials. Our approach focuses on expanding access to all appropriate patient groups through review and amendment of protocol designs, selecting geographically accessible clinical trial sites, soliciting insights from patients, investigators and healthcare providers who participate in our trials, and working with advocacy groups and community-based organizations to improve recruitment, enrollment and retention.
In clinical trial programs for Alzheimer’s disease, recruitment of a variety of populations is imperative to the generalizability of results and to ensure adequate representation of all communities affected by dementia. Significant efforts have been made to enhance the recruitment and enrollment of participants across demographics in our clinical trials in early Alzheimer’s disease. Eisai achieved the highest representation of participants in any Alzheimer’s disease Phase 3 clinical trial to date with the Clarity AD study. Efforts that led to this achievement included, but were not limited to, selection of sites and investigators who had access to different communities, conducting community outreach in various settings (i.e., local activity centers, churches) and decentralizing clinical trial activities to reduce burden on participants. Significant innovations in the preclinical Alzheimer’s disease AHEAD study for 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 is just one example of our company’s commitment to transparency and our efforts toward achieving adequately representative populations in our trials. We are committed to evolving the paradigm of clinical trial standards and fostering engagement and equal access for all patients.
Eisai will continue to explore ways by which we can expand participation in clinical trials through partnering with patients, care partners, advocates, hospitals, institutions, healthcare providers, regulators, and other pharmaceutical companies. Our ongoing efforts will evolve with the help and partnership of our patients, the health care community and our employees.