NEW HAVEN, Conn., July 10, 2019 /PRNewswire/ -- Bioethics International (BEI), a not-for-profit organization dedicated to raising the bar on ethics, trustworthiness and patient-centricity in the pharmaceutical industry, today announced the third publication of its Good Pharma Scorecard (GPS) in The BMJ. The GPS is an annual ranking of new drugs and the associated pharmaceutical companies on their ethics performance. This year's rankings focus on clinical transparency and data-sharing practices in large pharmaceutical companies, specifically on trial registration, results reporting, publication and data-sharing practices. BEI, in collaboration with Yale School of Medicine and Stanford Law School, developed new data sharing measures, which were informed by a multi-stakeholder advisory team.
Two companies, Novo Nordisk and Roche, tied for the top rank in overall trial transparency, each with scores of 100%. Novo Nordisk, Roche, Novartis and Janssen/Johnson & Johnson all achieved scores of 100% on the data-sharing measure.
In addition to measuring companies' data-sharing practices, the study tested whether the GPS ranking tool could improve companies' practices. BEI provided companies a 30-day window to amend their policies to meet the new data-sharing measure. At the end of the window, three companies improved their policies. Additionally, since the first GPS published rankings in 2015, the industry's overall median transparency scores have gone up year after year.
"A goal of the GPS is to help set ethics and social responsibility measures in the pharma industry and provide an independent tracking tool to both recognize best practices and catalyze reform, where needed, in companies," said Jennifer E. Miller, Ph.D., founder of Bioethics International, assistant professor at the Yale School of Medicine and lead author on the paper. "We are encouraged by the efforts of some large companies to share patient-level trial data and a willingness to improve policies and practices, where needed. However, there is substantial room for improvement. Providing companies with a consistent, fair and achievable set of measures is important to encouraging and tracking further progress toward routine data sharing."
A few companies' data-sharing commitments exceeded the standards measured. Novo Nordisk, for example, provides access to trial data sooner than the standard required. Some companies also commit to sharing data for additional types of trials, such as Phase 1 and 4 trials. After the 30-day amendment period, three companies changed their policies. AstraZeneca added a new provision to report annually the number of received data requests and the outcome of each. Novartis added timelines for data sharing where previously none were specified. Gilead substantially expanded its data-sharing policy by adding timelines for data sharing.
Dr. Miller added, "Never before have we created so much digital health data about a person, from such a wide variety of sources and so quickly, raising novel ethics questions about the responsibilities of data collectors, like pharmaceutical companies. The ethics challenges and potential benefits of data-sharing are novel partly because big data is a relatively new phenomenon, with most of the world's data (~90%) produced in just the last two years or so. Much of the world's regulatory infrastructure does not yet adequately address the new and emerging ethics challenges and public health opportunities of data sharing. The GPS measures can help provide a unique platform to both discuss and address critical new ethics challenges and opportunities raised through healthcare innovation."
For the full GPS rankings, visit: https://bioethicsinternational.org/good-pharma-scorecard/
About Bioethics International
Bioethics International's mission is to help transform the way we understand, engage, and operationalize bioethics in the healthcare innovation sector, to improve its trustworthiness and patient-centricity and advance health. Currently, Bioethics International focuses on the ethics and governance of how medicines and vaccines are researched, developed, marketed and made accessible to patients around the world as well as the ethics concerns around the collection, use and sharing of health data. For more information, please visit www.bioethicsinternational.org.
This Good Pharma Scorecard was supported by Arnold Ventures.
Disclaimer from Arnold Ventures
The views expressed in the report are the authors' and do not necessarily reflect those of the foundation.
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SOURCE Bioethics International