How Full Disclosure of Clinical Trial Data will Benefit the Pharmaceutical Industry
Miller JE (2016). The Pharmaceutical JournalDOI: 10.1211/PJ.2016.20201274
Disclosing clinical trial data is a step in the right direction towards transparency, which benefits both the public and the pharmaceutical industry.
Clinical Trial Registration, Reporting, Publication and FDAAA Compliance: A Cross-sectional Analysis and Ranking of New Drugs Approved By the FDA In 2012.
Miller JE, Korn D, Ross JS. Clinical trial registration, reporting, publication and FDAAA compliance: a cross-sectional analysis and ranking of new drugs approved by the FDA in 2012. (2015). BMJ Open; 5:e009758. doi:10.1136/bmjopen-2015-009758.
Trial disclosures for new drugs remain below legal and ethics standards, with wide variation in practices among drugs and their sponsors. Best practices are emerging. 2 of our 10 reviewed companies disclosed all trials and complied with legal disclosure requirements for their 2012 approved drugs. Ranking new drugs on transparency criteria may improve compliance with legal and ethics standards and the quality of medical knowledge
BrinkNews.com, July 3, 2015,
Article by: Jennifer E. Miller Assistant Professor of Medical Ethics, NYU Langone Medical Center and President of Bioethics International
Miller, J. E. (2013). How a Clinical Trial Registry Became a Symbol of Misinformation. Hastings Center Report, 43 (6), 11-12.
The intent of the first national clinical trials registry for cancer therapies was to help doctors find open trials in which to enroll their patients and to help researchers maintain a steady supply of research participants. However, it ended up exposing corrupt practices and tensions between ethics, the corporate need for profits, and public health goals. How did this happen?
Miller, J. E. (2013). Bioethical Accreditation or Rating Needed to Restore Trust in Pharma. Nature Medicine, 19 (3), 261.
After years of decline in the public eye, drug companies should implement a bioethics accreditation or rating program to help appropriately restore the industry’s good name and improve its effectiveness in advancing global health and new treatments.
From Bad Pharma to Good Pharma: Aligning Market Forces with Good and Trustworthy Practices through Accreditation, Certification and Rating
Miller, J. E. (2013). From Bad Pharma to Good Pharma: Aligning Market Forces with Good and Trustworthy Practices through Accreditation, Certification and Rating. Journal of Law, Medicine, and Ethics, 41 (3), 601-610.
This article explores whether the bioethical performance and trustworthin ess of pharmaceutical companies can be improved by harnessing market forces through the use of accreditation, certification, or rating.