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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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Metrics, baseline scores, and a tool to improve sponsor performance on clinical trial diversity: retrospective cross sectional study, BMJ Medicine

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.

Varma T, Mello M, Ross JS, Gross CP, Miller JE., Metrics, baseline scores, and a tool to improve sponsor performance on clinical trial diversity: retrospective cross sectional study, 

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  

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Press and Media Inquires

Press and media inquiries can be directed to:

Jennifer E. Miller, PhD
jem@bioethicsinternational.org

jennifer.e.miller@yale.edu

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