June 24, 2025 8:00am to 6:00 pm
Join us for Bioethics International & EY’s 16th Annual Pharmaceutical Executive Roundtable w/ Yale’s Program for Biomedical Ethics & Scientific American
Ethics, Trust + Patient Centricity in Pharma: Defining Metrics for Success
June 24, 2025 8:00am to 6:00 pm
Join us for Bioethics International & EY’s 16th Annual Pharmaceutical Executive Roundtable w/ Yale’s Program for Biomedical Ethics & Scientific American
Ethics, Trust + Patient Centricity in Pharma: Defining Metrics for Success
June 24, 2024 8am - 4pm
September 15, 2023 8am-3pm
This year’s roundtable (in its 14th year) will focus on metrics + strategies for advancing bioethics, patient-centricity + health equity across the bio-pharmaceutical sector and amplifying + connecting participants’ work in these areas. Discussions may inform agenda-setting + metrics development for the Good Pharma Scorecard. Sessions will begin w/ opening remarks + transition to open discussion.
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
The New York Times interviewed our founder, Jennifer Miller, on FDA Commissioner Dr. Scott Gottlieb's clinical trial transparency initiatives. She discussed his new pilot, launched last month, which selects 9 recently-approved drugs, whose sponsors (generally pharmaceutical companies) volunteer to participate, to post portions of Clinical Study Reports (CSRs) from their pivotal trials on FDA's website…
February 12, 2018
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,
