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Webinar: Blockchain as pharma’s ‘trust catalyst’

June 27, 2018 9:00-10:00am

Blockchain technology offers many things. But if all you know about blockchain is bitcoin, you might be surprised to hear it may offer pharma an opportunity for more trustworthiness and transparency. In this free webinar we’ll be going beyond privacy, beyond honesty, beyond trust. We’ll explore how new technology and contract innovation offers a route for each and every human being to take control of their own data as their own property. And how pharma companies might welcome this development with open arms.

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DIA Global Clinical Trial Disclosure and Data Transparency Conference, London

September 20, 2018 2:00-3:30pm

Public Accountability Around Disclosure
Merete Jørgensen, Senior Trial Disclosure Director, Clinical Reporting Anchor & Disclosure, Novo Nordisk, Denmark
Fiona Godlee, Editor in Chief, British Medical Journal (BMJ), United Kingdom
Jennifer Miller, Founder, Bioethics International and Good Pharma Scorecard, Assistant Professor, Yale University School of Medicine, United States of America
Lise Baltzer, Director for Global Publications, Novo Nordisk, Denmark

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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

Availability of Investigational Medicines Through the US Food and Drug Administration’s Expanded Access and Compassionate Use Programs

Jeremy Puthumana, MS; Jennifer E. Miller, PhD; Jeanie Kim, JD; et al Joseph S. Ross, MD, MHS. JAMA Network Open. 2018;1(2):e180283. doi:10.1001/jamanetworkopen.2018.0283
The Right to Try Act of 2017 allows patients with life-threatening conditions to access investigational medicines outside clinical trials without oversight from the US Food and Drug Administration (FDA). A better understanding of existing expanded access programs can inform the consideration and implementation of both the federal Right to Try Act and state right-to-try laws.

Measuring clinical trial transparency: an empirical analysis of newly approved drugs and large pharmaceutical companies

Miller JE, Wilenzick M, Ritcey N, et al. Measuring clinical trial transparency: an empirical analysis of newly approved drugs and large pharmaceutical companies. BMJ Open 2017;0:e017917. doi:10.1136/ bmjopen-2017-017917

Cross-sectional descriptive analysis of all clinical trials supporting 2014 Food and Drugs Administration (FDA)-approved new drug applications (NDAs) for novel drugs sponsored by large companies.

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Press and Media Inquires

All press and media inquiries should be directed to:

Maggie Beller, Russo Partners LLC
maggie.beller@russopartnersllc.com
646-942-5631

Naomi Bowen, Behrman Communications
bioethics@behrmanpr.com
212-986-7000 ext. 119

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