Bristol Meyers Squibb
International Aids Vaccines Initiative
Johnson and Johnson
NYU Langone Medical Center
University of Pennsylvania
Welcome and Introductions. Welcome: Jennifer Miller, David Korn and Art Caplan
- All participants: Who you are, why you are here, and what you hope to gain from the roundtable.
Background. Ethics and trust in the pharmaceutical industry: Could rating help?
- Brief history of the index from 2009 to present.
- Introduction to the pilot rating’s scope, criteria, methodology, and results.
Discussion on the scope, criteria, methods, limitations and results for the pilot index.
- Ethics Index: ranking of 2012 FDA approved drugs according to the voluntary ethical principle that all trial results should be publicly available
- Legal Compliance Index: Ranking of drugs according to compliance with FDAAA
- Is our understanding of ethics the same as yours or how the industry understands it?
- Summary of the spectrum of understandings for how companies interpreted FDAAA.
- Should we broaden the index to include other trial sponsors, if so, how?
- What are the similar existing and emerging initiatives and how should we fit in with them (e.g Goldacre)?
- How should we put this rating “out there” so it is credible, reliable, accurate, fair and effective? This includes a discussion on (1) appropriately framing the results, (2) visibility, (3) governance, (4) funding, (5) naming the index, and (6) where to publish.
2013 Rankings. Should we add criteria for data sharing? Should we add other focus areas? Last year companies asked to address (1) concerns about the exploitation of research subjects in developing countries and (2) the return of research results to trial participants. Are there other areas you think you are doing particularly well for which you would like credit/to showcase, or if it turns out you’re not, you’re interested in figuring out why and how to improve things?
Follow up tasks, expectations, and action items. Thank you!