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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

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

Press and media inquiries can be directed to:

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

Jennifer Miller, Yale School of Medicine
jennifer.e.miller@yale.edu

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