Measuring clinical trial transparency: an empirical analysis of newly approved drugs and large pharmaceutical companies

Miller JE, Wilenzick M, Ritcey N, et al. Measuring clinical trial transparency: an empirical analysis of newly approved drugs and large pharmaceutical companies. BMJ Open 2017;0:e017917. doi:10.1136/ bmjopen-2017-017917

Cross-sectional descriptive analysis of all clinical trials supporting 2014 Food and Drugs Administration (FDA)-approved new drug applications (NDAs) for novel drugs sponsored by large companies.

Characterizing Expanded Access and Compassionate Use Programs for Experimental Drugs

Miller JE, Ross JS, Moch KI, Caplan AL. Characterizing expanded access and compassionate use programs for experimental drugs. (2017). BMC Res Notes. DOI: 10.1186/s13104-017-2687-5.

Most (76%) provided drugs in expanded access programs eventually received FDA approval. Thus, provided drugs in registered expanded access programs are, more times than not, eventually deemed safe by the FDA.

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

How a Clinical Trial Registry Became a Symbol of Misinformation

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?

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 trustworthiness of pharmaceutical companies can be improved by harnessing market forces through the use of accreditation, certification, or rating.

Bioethical accreditation or rating needed to restore trust in pharma

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.