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.
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
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
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
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.
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.