May 3, 2027 — May 5, 2027
Bioethics International & EY’s 18th Annual Pharmaceutical Executive Roundtable on Ethics, Trust + Patient Centricity in Pharma. New York City.
The event date will be earlier next year on May 3rd, 4th or 5th. We will finalize soon.
The Roundtable is co-hosted with Yale Medicines Access Network (YMAN), Yale Program for Biomedical Ethics, and Scientific American.
This annual roundtable is the leading forum for senior leaders in healthcare, including industry, patient groups, and academia, to discuss the state of bioethics and patient centricity in medicine development and access and the role of the pharmaceutical sector.
May 3, 2027 — May 5, 2027
Bioethics International & EY’s 18th Annual Pharmaceutical Executive Roundtable on Ethics, Trust + Patient Centricity in Pharma. New York City.
The event date will be earlier next year on May 3rd, 4th or 5th. We will finalize soon.
The Roundtable is co-hosted with Yale Medicines Access Network (YMAN), Yale Program for Biomedical Ethics, and Scientific American.
This annual roundtable is the leading forum for senior leaders in healthcare, including industry, patient groups, and academia, to discuss the state of bioethics and patient centricity in medicine development and access and the role of the pharmaceutical sector.
Bridging the Gap Between Clinical Trials and Access: Launching the Yale Medicines Access Network (YMAN) Across the globe, patients in low- and middle-income countries (LMICs) are increasingly participating in clinical trials that support regulatory approvals of novel medicines. Yet too often, once those medicines are approved—particularly by the U.S. Food and Drug Administration (FDA)—they remain…
April 6, 2026
When countries hosts clinical trials for new medicines and vaccines, most of us assume patients there will eventually benefit from the products they helped test. According to the Declaration of Helsinki and Council for International Organizations of Medical Sciences (CIOMS) guidelines, populations who bear the burdens of research should share in its benefits.Our new study…
January 6, 2026
Key Points
Question Are medicines physically accessible in the countries where they are tested for US Food and Drug Administration (FDA) approval, and has physical access improved over time?
Findings In this cross-sectional study of 172 medicines approved by the FDA from 2015 to 2018 and tested in 89 countries, 24% were physically accessible in all countries where they were tested 5 years after FDA approval. Countries in Western Europe had notably better access (82%) than countries in Africa (28%), with no improvements over time for low- and middle-income countries.
Meaning Most countries participating in trials for FDA approvals cannot physically access the medicines they test, particularly low- and middle-income countries, raising exploitation concerns, with no improvements over time.
Importance Populations participating in clinical trials should stand to benefit from resulting interventions, according to ethical guidance. Yet, our studies show low- and middle-income countries (LMICs) participating in trials for US Food and Drug Administration (FDA) approvals lack timely access to the medicines they help test, raising exploitation concerns.
See full study in JAMA IM here.
Objective To develop a measure for fair inclusion in pivotal trials by assessing transparency and representation of enrolled women, older adults (aged 65 years and older), and racially and ethnically minoritized patients.
Design Retrospective cross sectional study of sponsors of novel oncology therapeutics approved by the FDA 2012-2017
Results Between 2012 and 2017, the FDA approved 59 novel cancer therapeutics, submitted by 25 sponsors (all industry companies) on the basis of 64 pivotal trials. All 25 sponsors (100%) reported participant sex, 10 (40%) reported age, and six (24%) reported race and ethnicity. Although 14 (56%) sponsors had adequate representation of women in trials, only six (24%) adequately represented older adults, and four (16%) adequately represented racially and ethnically minoritized patients (black, Asian, Hispanic or Latinx). On overall fair inclusion, one sponsor scored 100% and the median sponsor score was 81% (interquartile range 75-87%). More than half of sponsors (13 (56%) of 25) fairly included women, 20% (n=5) fairly included older adults, and 4% (n=1) fairly included racially and ethnically minoritized patients in trials. 80% of product had pivotal trials that fairly included women, 24% fairly included older adults, and 5% fairly included racially and ethnically minoritized patients.
, Gross CP, Miller JE., Metrics, baseline scores, and a tool to improve sponsor performance on clinical trial diversity: retrospective cross sectional study,
