May 2, 2019 8:30am-2:30pm
In partnership with EY and Scientific American, Bioethics International will hosts its 10th annual Forum on what it means to be a trustworthy, patient-centered & ethical pharma and healthcare innovation company.
Location: New York, NY
June 23, 2019 — June 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
June 5, 2019 — June 7, 2019
Dr. Jennifer E. Miller answers “Whose Data Is It” question.
This 75-minute session will look at the ethical considerations, legal aspects, coaching perspectives and athletic viewpoints related to ownership of sports biometric data. This session will be moderated by Jeremy Abbate from Scientific American.
Location: Columbus, Ohio
May 2, 2019 8:30am-2:30pm
In partnership with EY and Scientific American, Bioethics International will hosts its 10th annual Forum on what it means to be a trustworthy, patient-centered & ethical pharma and healthcare innovation company.
Location: New York, NY
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
Miller, JE and Price, A. Data sharing in clinical trials: keeping score. BMJ. 2019
There are many questions over who should have access to health data and who owns them. These issues are complicated in clinical trials where data are co-produced by participants, researchers, clinicians, funders, and industry. Ninety percent of all data ever produced were produced in the past two years, raising novel ethical questions about the responsibilities of data collectors and the rights of participants. [1] These questions are particularly acute for clinical trial data, which hold life-saving potential and can advance patient and population health…
Miller J, Ross J, Wilenzick M, Mello M. Sharing of clinical trial data and results reporting practices among large pharmaceutical companies: cross sectional descriptive study and pilot of a tool to improve company practices BMJ 2019; 366
Public expectations for transparency in the conduct and reporting of clinical trials continue to evolve. Today, the transparency discussion has shifted to new terrain: sharing of patient level clinical trial data. Evaluating and tracking progress on the implementation of data sharing among pharmaceutical companies is, however, difficult. Existing guidelines for what should be shared, how, and when vary widely and are often vague. As part of a larger project called the Good Pharma Scorecard, we developed a harmonized, practical set of measures and a tool for assessing sharing of participant level clinical trial data by research sponsors and applied them to measure policies and practices among large pharmaceutical companies with drugs newly approved by the FDA in 2015. We also evaluated the feasibility of the tool (a ranking system) in improving companies’ practices. We found 25% of large pharmaceutical companies fully met the data sharing measure. Given feedback and a chance to improve their policies to meet this measure, three companies made amendments, raising the percentage of companies in full compliance to 33%.
