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BEI Event

Pharmaceutical Executive Bioethics Roundtable

June 9, 2022 9am-4:15pm

This year’s bioethics roundtable, our 12th!, is hosted by Deloitte and will focus on equity and social responsibility in the bio-pharmaceutical sector and debut our new Good Pharma Scorecard (GPS) rankings on diversity and fair inclusion in research.

When: June 9, 2022 – 9am-4:15pm ET

Where: Deloitte’s NYC Offices

Register Here: Pharma Executive Roundtable RSVP Form

BI Roundtable Flyer

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Other Event

Balancing Economics and Ethics: How Can VA/HTA Support Equitable Resource Allocation?

September 21, 2020 1:00PM-2:15PM EDT

ISPOR and the Innovation and Value Initiative (IVI) are collaborating—with help from an expert advisory committee—to define a series of dialogues that highlight key challenges confronting HEOR methodologists, patients, clinicians, and policy-makers during the COVID-19 pandemic. The webinar series will explore multiple viewpoints and focus on potential pathways for solutions in international and U.S.-focused health technology assessment and value assessment (VA/HTA).

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Other Event

DIA Facilitating Access: Patients’ perspectives on a streamlined development approach to treatments for debilitating diseases

June 23, 2019June 27, 2019

Panelists will explore the pros and cons of the pathway from the patient perspective and learn about how regulators and sponsors may help facilitate the development of critically needed treatments.  This discussion will introduce a streamlined approach to early-stage development of therapies to address severely debilitating or life-threatening diseases and consider the potential value of a global regulatory approach.

Location: San Diego, CA

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Blog

New York Times interviews our founder, Jennifer Miller, on FDA's clinical trial transparency pilot

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

Big Data Probably Knows More About You Than Your Friends Do

This week we focused on the ethics of Big Data, publishing an article titled, Big Data Probably Knows More About You Than Your Friends Do, in Leaps Mag. The article discusses the promises and perils of big data and concludes with a way to manage your data wealth.  To read the full article click here.

February 7, 2018

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Publications

Evaluation of Drug Trials in High, Middle, and Low-Income Countries and Local Commercial Availability of Approved Drugs

Question  How commonly are drugs commercially available in the countries where they were tested?

Findings  This cross-sectional study found that 5 years after their approval in the US, 15% of novel drugs (5 of 34 drugs) were approved in all countries where they were tested; among 70 countries contributing research participants, 7% (5 countries) received market access to the drugs they helped test within 1 year of US approval and 31% (22 countries) did so within 5 years. Approvals were faster in high-income countries, and access was lowest in African countries.

Meaning  These findings suggest that substantial gaps exist between where drugs are tested and where they become available to patients, raising concerns about the equitable distribution of research benefits.

Published: May 5, 2021. Miller JE et al. JAMA Network Open 10.1001/jamanetworkopen.2021.7075  

BMJ Global Health: Ethical considerations in international clinical trial site selection

New medicines and vaccines are predominantly tested in high-income countries. However, as the COVID-19 pandemic highlighted, the populations who can benefit from these interventions are not limited to these wealthier regions. One-third of novel Food and Drug Administration approved drugs, sponsored by large companies, treat infectious diseases like tuberculosis and HIV, which disproportionately affect low-income and middle-income countries (LMICs). The medicines for non-communicable diseases (NCDs) are also relevant to LMIC health needs, as over three-quarters of deaths from NCDs occur in LMICs. There are concerns clinical trial data may not extrapolate across geographical regions, as product effectiveness can vary substantially by region. The pentavalent rotavirus vaccine, for example, had markedly lower efficacy in LMICs. Efficacy variations have also been found for other vaccines and drugs. We argue there are strong ethical arguments for remedying some of this uneven distribution of clinical trial sites by geography and income. Chief among them, is that these disparities can impede equitable access to the benefits of clinical research, such as representation in the evidence base generated to guide prescribing and use of medicines and vaccines. We suggest trial site locations should be made more transparent and for later stage trials their selection should be informed by the global distribution of disease burden targeted by an experimental product. Countries with high prevalence, incidence, severity or infection transmission rates for targeted diseases should have real opportunities to engage in and enrol their populations in trials for novel medicines and vaccines. Citation: Miller J, Millum J, Ethical considerations in international clinical trial site selection, 

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Press and Media Inquires

Press and media inquiries can be directed to:

Jennifer E. Miller, PhD
jmiller@bioethicsinternational.org

jennifer.e.miller@yale.edu

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