关于我们
Bioethics International’s (BEI) mission is to empower professionals and organizations in healthcare, life science and biotechnology to make responsible decisions – on issues that impact patients the most. Currently, we focus on the ethics and governance of how medicines are researched, developed, marketed and made accessible to patients around the world. Our main project, the "Good Pharma Scorecard" (GPS), is an Index that ranks the 20 largest pharma and biotech companies and new drugs on their ethics and transparency performance. Our first GPS scorecard ranked companies and new drugs on their R&D and clinical trial transparency performance.
- 网站
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https://www.bioethicsinternational.org
Bioethics International的外部链接
- 所属行业
- 医院和医疗保健
- 规模
- 2-10 人
- 总部
- New York
- 类型
- 非营利机构
地点
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主要
获取路线
227 E. 30th Street
US，New York，10170
Bioethics International员工
动态
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Representation in clinical trials hasn’t measurably improved in over a decade: bit.ly/4gwFQcB In our latest installment of #ClinicalEquality Sessions, we speak to Jennifer E. Miller, who is changing the game by giving clinical trial sponsors a diversity scorecard. #ClinicalTrials
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CoDirector, Program for Biomedical Ethics, Associate Professor, Yale School of Medicine. Founder, Bioethics International. Interim CEO, Good Pharma Scorecard
Our BMJ med study developed indicators for representation in clinical research. We applied the indicators to assess 50 #pharma companies' #clinicaltrial diversity #policies. Indicators include: (1) use of enrollment targets that reflect the prevalence of targeted conditions in populations, (2) broad eligibility criteria in trials, (3) diverse workforce, (4) identification and remedy of barriers to trial recruitment and retention, (5) incorporation of patient input into trial design, (6) advancing public health literacy, (7) multidimensional approaches to diversity, (8) selection of sites with diverse providers and patient populations, (9) data collection after product approval, (10) diverse enrollment in every country where trials are conducted, (11) diverse enrollment should be a focus for all phases of clinical trials, not just later stage or pivotal trials, (12) varied trial design, (13) expanded access, and (14) public reporting of trial participant demographics. We found 48% (24/50) of companies had no #publicpolicy on representation in clinical trials; among those w policies, content varied widely. Large companies were more likely to have a public policy than non-large (84% v 20%, P<0.001). Large companies most frequently committed to using epi based trial enrollment targets representing the prevalence of indicated conditions in various populations (71%), dealing w barriers to trial recruitment (71%), & improving patient awareness of trial opportunities (67%). Company location was not associated w having a public diversity policy (P=0.17). The average company policy had 5 of the 14 commitments recommended in FDA, IFPMA PhRMA European Medicines Agency & other stakeholder guidance. Our findings show that many pharmaceutical companies do not have public policies on diversity in clinical trials, although policies were more common in large than non-large companies. Policies that were publicly available varied widely and lacked important commitments recommended by stakeholder guidance. These findings suggest that corporate policies can be better leveraged to promote representation and fair inclusion in research, and implementation of FDA and stakeholder guidance. Thx to coauthors Joseph Ross Cary Gross Reshma Ramachandran Jason Schwartz Michael Mensah Sakinah Carter Suttiratana Will Pelletiers
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We are grateful to Amrit Ray, M.D., Hastings Center for Bioethics board member, for moderating our access to medicines panel last week w Ipek ?zer Stillman Tanisha Carino Tom Lee Steve Pascoe Frank Marra - co hosted w Lauren Rogge Arda Ural, MSc, MBA, PhD of EY
Board Chairman & Director ? Physician Researcher and Advocate for Healthcare Access ? Former Global President, Head of R&D and Medical, Pfizer
Congrats to Prof. Jennifer E. Miller and Bioethics International for 15 years of leading the Pharmaceutical Executive Roundtable and exemplifying the old proverb — “If you want to go far, go together." It was an honor to moderate a dialogue with Seema Verma, Thomas Lee, MD, Ipek ?zer Stillman, Steve Pascoe, Tanisha Carino and Frank Marra on the complexities of healthcare delivery and Access to Medicines for Patients in the US. Well done to Lauren Rogge, Yele Aluko MD, MBA, FACC, and EY, and Jeremy Abbate and Scientific American for supporting, and to Elisabeth Armstrong, John Wig, David Leventhal, Darryl Sleep, MD (MBBCh, FCS(SA)), Mike Rea, Greg Licholai, Pierre Theodore and all who joined to support transparency and ethics in pharma. #transparency #pharma #ethics
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