Data sharing in clinical trials: keeping score

Miller, JE and Price, A. Data sharing in clinical trials: keeping score. BMJ. 2019

There are many questions over who should have access to health data and who owns them.  These issues are complicated in clinical trials where data are co-produced by participants, researchers, clinicians, funders, and industry. Ninety percent of all data ever produced were produced in the past two years, raising novel ethical questions about the responsibilities of data collectors and the rights of participants. [1] These questions are particularly acute for clinical trial data, which hold life-saving potential and can advance patient and population health…

Sharing of clinical trial data and results reporting practices among large pharmaceutical companies

Miller J, Ross J, Wilenzick M, Mello M. 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 2019; 366

Public expectations for transparency in the conduct and reporting of clinical trials continue to evolve. Today, the transparency discussion has shifted to new terrain: sharing of patient level clinical trial data. Evaluating and tracking progress on the implementation of data sharing among pharmaceutical companies is, however, difficult. Existing guidelines for what should be shared, how, and when vary widely and are often vague. As part of a larger project called the Good Pharma Scorecard, we developed a harmonized, practical set of measures and a tool for assessing sharing of participant level clinical trial data by research sponsors and applied them to measure policies and practices among large pharmaceutical companies with drugs newly approved by the FDA in 2015. We also evaluated the feasibility of the tool (a ranking system) in improving companies’ practices. We found 25% of large pharmaceutical companies fully met the data sharing measure. Given feedback and a chance to improve their policies to meet this measure, three companies made amendments, raising the percentage of companies in full compliance to 33%.

Availability of Investigational Medicines Through the US Food and Drug Administration’s Expanded Access and Compassionate Use Programs

Jeremy Puthumana, MS; Jennifer E. Miller, PhD; Jeanie Kim, JD; et al Joseph S. Ross, MD, MHS. JAMA Network Open. 2018;1(2):e180283. doi:10.1001/jamanetworkopen.2018.0283
The Right to Try Act of 2017 allows patients with life-threatening conditions to access investigational medicines outside clinical trials without oversight from the US Food and Drug Administration (FDA). A better understanding of existing expanded access programs can inform the consideration and implementation of both the federal Right to Try Act and state right-to-try laws.

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

Jennifer E. Miller, Joseph S. Ross, Kenneth I. Moch and Arthur L. Caplan BMC Research Notes 2017 10:350 https://doi.org/10.1186/s13104-017-2687-5
We sought to determine the characteristics of “expanded access” and “compassionate use” programs registered in ClinicalTrials.gov and to determine the percentage of drugs provided through these programs that ultimately received FDA marketing approval.

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.