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| Founder(s) | Jennifer E. Miller, PhD |
|---|---|
| Established | 2005 |
| Mission | 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 |
| President | Jennifer E. Miller, PhD |
| Managing Director | Wilco Faessen |
| Address | 420 Lexington Avenue, Suite 300 |
| Location | , NY , |
| Website | https://bioethicsinternational.org/ |
The non-profit charity Bioethics International assesses compliance with bioethics in clinical trials in health, mainly in pharmacology. The bioethics criteria encompass the transparency in the publication of information on how the trial was conducted and the publication of the data collected. Several thousand clinical trials have been assessed.[1]
Based on the evaluations of clinical trials, Bioethics International also produces a dashboard of the transparency of many pharmaceutical companies: the “Good Pharma Scoreboard”[2]. This publication seems to drive the pharmaceutical companies to work to get good results, and many are successful.
Mission
editThe mission of Bioethics International 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.[3]
The organization has been working since 2020 on ethical standards in clinical trials: how they are designed, how they are conducted and how the results are shared. Bioethics International is also looking at the marketing techniques and the access to drugs.[4]
History
editDr. Jennifer E. Miller co-founded "Bioethics International" in 2005 with the goal of advancing biomedical ethics and to put the patient's place in the center of any therapy. The organization is recognized as a charitable organization in New York State and the United States.[3]
Organisation
editThe organization brings together a team of researchers[5], ethicist and science advisers, directors.[6]
Representatives from foundations, industry, patient groups, governments, academia and socially responsible investors participate on the exchange platforms to discuss bioethics and trust concerns, and exchange ideas on how to improve practices and trustworthiness in the work of the organization.[3]
Values
editSince its foundation, Bioethics International has considered the openness of research in science and in business management (transparency) as a fundamental ethical principle of communication with the public and of the scientific approach in medicine and pharmacology[1]. Open Science approaches are proposed as one way to help increase the reproducibility of trials[7] as well as to help mitigate against manipulation of data.
Bioethics International promotes better compliance with the regulations;[2] registration of clinical trials; respect and protection of participants in clinical trials; access to data by practitioners and drug users.[8]
Accomplishments
editPromotion and Advancement of Ethics in Biomedical Research
editBioethics International develops and improves its ethical standards[9] with the aim that practitioners get valid, complete and objective information about clinical trials so that they can prescribe the right medicine to the right patient at the right time. Patients, as partners in their own care and with respect for human dignity[10], also need this information to make informed decisions about the choice of their treatment.[11]
Publishing all the data also helps biomedical research[12][13] because it avoids redoing work whether trials pass or fail. This saves resources and helps avert wasted time. The quality of the data is based on the quality of the trials and unbiased statistical analysis, the publication of the data makes those validation possible.[14] Although the biomedical world is often blamed on the quality of information, it must, to be fair, recognize that this situation is found elsewhere in scientific research.[15]
In addition to the above requirements, they established ethical standards for the conduct of trials[16], inspired by the values of open science (transparency). These standards cover compliance with clinical trial participants, anonymized information about them, legal compliance, publication, and the quality of clinical trial protocols.
To carry out its work on standards, Bioethics International brings together stakeholders in committees and creates knowledge exchange platforms in these areas.
Assessment of the Ethical Level of Pharmaceutical Companies
editBioethics International produces a dashboard evaluating pharmaceutical companies, the “Good Pharma Scoreboard” (GPS).[2] The dashboard is based on two indicators whose scale is in percent. The first indicator is the “Data-sharing-ranking” on clinical trials. The second indicator assesses the level of compliance with ethical standards. By 2021, several thousand clinical trials had been evaluated[8].
The score of a pharmaceutical is the average of the test results.[17]
Results
editIn 2019, several pharmaceutical companies fully or nearly met the ethical standards: Novo Nordisk and Roche (100%) and Novartis (99%). And at least six other companies exceed 75%.
For data sharing, four companies get a perfect score of 100% on data sharing: Johnson & Johnson, Novartis, Novo Nordisk and Roche. Five other companies exceed 75%.[8]
Impact on Pharmaceutical company
editIn addition to measuring companies’ data-sharing practices, the study tested whether the GPS ranking tool could improve their practices. Bioethics International 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.[18]
Now in its third edition, the research found that the proportion of the large pharmaceutical companies that share the data on their clinical research is on the upswing, with 95% of patient trials and now providing public results within six months of FDA approval. If the period is extended to 12 months, that improves to 100% for the new drugs reviewed after approval in 2015.[19]
A spokesman for Allergan said that “Allergan believes in clinical trial data transparency and welcomes analyses that help it and the industry improve transparency reporting to the medical community, patients, payers and others regarding its clinical trials.”[20]
| “ | Many also use their GPS results in their annual reports, which itself creates an incentive to improve year over year. Health-care investors, especially those concerned with social responsibility, have begun to use the GPS in their Environmental-Social-Governance analyses. It has been hopeful to see many large multinational companies changing nimbly and quickly, and tracking their progress year after year. | ” |
| — Jennifer E. Miller, in Scientific American | ||
Bioethic and Healthcare Innovation
editBioethics International studies innovations, in general, in the medical field from the point of view of bioethics and offers consultation on its research. The organization has a particular interest in innovations posing health risks for the population.[4]
Other development
editBioethics works to develop performance indicators on the design of clinical trials, the marketing and accessibility of drugs.[1]
Fundraising and partnership
editThe projects received support from the public, several universities like the Harvard University, the Duke University and recently from think tank like the Faster Cures and the Milken Institute.
The Harvard School of Medicine, the Yale University and Stanford School of Law provide the investigators to collect data and compile the information to establish the “Good Pharma Scorecard.”
Scientific American and E&Y co-sponsor the annual Bioethics forum which brings together stakeholders in bioethics and pharmacology.[21]
Comments on Bioethics International
editBioethics International has increased the openness of research in pharmaceutical companies by developing the GPS.[22] However, the results should be taken with a grain of salt as they apply primarily to the wealthiest pharmaceutical companies who have the resources and who want to keep a positive image for the public. Small biotechnology companies, in lesser number in the GPS, and most universities do not have all the resources necessary to meet all the criteria of the GPS.[23]
In addition, some criticize that more than half of the GPS 2019 publications do not provide any information about “Creative Commons” licences, stressing the need to focus more on the scope of the different types of licenses.[24]
In general, many consider that Bioethics International is an excellent resource for clinicians and anyone interested in ethics, providing individuals with expertise, experience and credibility in the field of medical ethics, as well as outstanding educational programs.[21][25]
References
edit- ^ a b c d E. Miller, Jennifer (2020). "The Good Pharma Scorecard". Scientific American. Archived from the original on 2021-02-06. Retrieved 2021-02-06.
- ^ a b c Health and Human Services Department (2016-09-21). "Clinical Trials Registration and Results Information Submission". Federal Register. Archived from the original on 2020-10-29. Retrieved 2021-02-06.
- ^ a b c "Who We Are". Bioethics International. Archived from the original on 2020-11-28. Retrieved 2021-02-04.
{{cite web}}: Unknown parameter|authors=ignored (help) - ^ a b Bioethics International (2021). "What We Do". Bioethics International. Archived from the original on 2020-10-31. Retrieved 2021-02-06.
- ^ Kashef, Ziba (2019-07-10). "Yale-developed scorecard promotes better clinical trial data sharing". YaleNews. Archived from the original on 2019-09-03. Retrieved 2021-02-13.
- ^ "Partners". Bioethics International. Archived from the original on 2020-10-31. Retrieved 2021-02-04.
- ^ Collaboration, Open Science (1 November 2012). "An Open, Large-Scale, Collaborative Effort to Estimate the Reproducibility of Psychological Science". Perspectives on Psychological Science. 7 (6): 657–660. doi:10.1177/1745691612462588. ISSN 1745-6916. PMID 26168127.
- ^ a b c Bioethics International (2020-11-24). "Good Pharma Scorecard | Bioethics International". web.archive.org. Archived from the original on 2020-11-24. Retrieved 2021-02-05.
- ^ Gillon, R (July 1994). "Medical ethics: four principles plus attention to scope". BMJ. 309 (6948): 184–8. doi:10.1136/bmj.309.6948.184. PMC 2540719. PMID 8044100. Archived from the original on 2021-01-17.
- ^ Immanuel Kant, Fundamental Principles of the Metaphysic of Morals, trans. by Thomas Kingsmill Abbott (Second Section: Transition From Popular Moral Philosophy To The Metaphysic Of Morals).
- ^ Entwistle VA, Carter SM, Cribb A, McCaffery K (July 2010). "Supporting patient autonomy: the importance of clinician-patient relationships" (PDF). Journal of General Internal Medicine. 25 (7): 741–5. doi:10.1007/s11606-010-1292-2. PMC 2881979. PMID 20213206. Archived from the original (PDF) on 2018-09-30.
- ^ Hilbert, Martin (2013-01-15). "Big Data for Development: From Information- to Knowledge Societies". SSRN. Rochester, NY. Archived from the original on 2021-01-09.
{{cite journal}}:|archive-date=/|archive-url=timestamp mismatch; 2021-02-01 suggested (help) - ^ Ross, Joseph S. (2021). "A New Culture of Sharing". Scientific American. Archived from the original on 2021-02-03. Retrieved 2021-02-10.
- ^ Crotty, David (2016-01-15). "Open Data and Trust in the Literature". The Scholarly Kitchen. Archived from the original on 2021-01-23. Retrieved 2021-02-10.
- ^ Ioannidis, John P. A. (August 1, 2005). "Why Most Published Research Findings Are False". PLOS Medicine. 2 (8): e124. doi:10.1371/journal.pmed.0020124. ISSN 1549-1277. PMC 1182327. PMID 16060722. Archived from the original on 2021-02-08.
{{cite journal}}: CS1 maint: unflagged free DOI (link) - ^ Institute of Medicine (2015-01-14). Sharing Clinical Trial Data: Maximizing Benefits, Minimizing Risk. Washington, DC: National Academies Press. ISBN 978-0-309-31629-3. Archived from the original on 2021-02-10.
{{cite book}}: CS1 maint: date and year (link) - ^ Miller, Jennifer; Ross, Joseph S.; Wilenzick, Marc; Mello, Michelle M. (2019-07-10). "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. 366. doi:10.1136/bmj.l4217. ISSN 0959-8138. PMID 31292127. Archived from the original on 2019-10-29.
- ^ Market Insider (2019-07-10). "Bioethics International's Good Pharma Scorecard Improved the Data-Sharing Practices of Large Pharmaceutical Companies". markets.businessinsider.com. Archived from the original on 2021-02-12. Retrieved 2021-02-12.
- ^ Snyder Bulik, Beth (2019-07-10). "Score! 'Good Pharma' ranking finds uptick in new drug data sharing and clinical trial transparency". FiercePharma. Archived from the original on 2020-10-25. Retrieved 2021-02-12.
- ^ Weintraub, Arlene (2017-12-14). "Pharma Ups Its Game On Trial Transparency But There's 'Room For Improvement'". Forbes. Archived from the original on 2021-02-12. Retrieved 2021-02-12.
- ^ a b Bioethics International (2021). Bioethics International (ed.). "Partners". Bioethics International. Archived from the original on 2020-10-31. Retrieved 2021-02-03.
- ^ Keown, Alex (2019-10-23). "Good Pharma Scorecard Continues to Boost Clinical Trial Transparency, Analyst Report Shows". BioSpace. Archived from the original on 2019-12-11. Retrieved 2021-02-13.
- ^ McLain, Kasim (2018-01-23). "Good Pharma Scorecard: Improvements Seen in Clinical Trial Transparency Compliance". TrialAssure. Archived from the original on 2021-02-13. Retrieved 2021-02-13.
- ^ MacDonald, Steph; Koder, Tim (2020-01-22). "How open are pharma publications?" (PDF). Open Pharma (PDF). Retrieved 2021-02-13.
{{cite web}}: Check|archive-url=value (help)CS1 maint: url-status (link) - ^ Mark R. Mercurio md, Director, Yale Pediatric Ethics Program, co-chair, Yale Hospital Ethics Committee, Professor, Yale University School of Medicine
External links
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