Report: Trial results disclosure falls below legal and ethical standards
In a recent study, only two-thirds of clinical trials per drug that supported new drug approvals in 2012 were disclosed, falling below legal and ethical standards.
The study was published by Bioethics International, a nonprofit focused on the ethics and governance of how medicines are researched, developed, marketed and made accessible to patients around the world. In addition, almost half of all reviewed drugs had at least one undisclosed phase II or III trial.
The rankings are the result of a study to evaluate clinical trial registration, reporting and publication rates for 15 new drugs approved by the FDA in 2012 by both legal requirements, as established by the 2007 U.S. Food and Drug Administration Amendments Act (FDAAA), and the ethical standard that all human subjects research should be publicly accessible to contribute to generalizable knowledge. Wide variation in practices among drugs and their sponsors was observed.
Three of 10 companies—GlaxoSmithKline, Johnson & Johnson and Pfizer—publicly disclosed all clinical trial results for at least one of their reviewed drugs, whereas the lowest scoring company, Gilead, disclosed 21% of the trial results for its HIV medicine Stribild. Sanofi's multiple sclerosis drug Aubagio also ranked low for publicly available information.
Incomplete disclosure of clinical trial results impacts the ability of healthcare decision-makers, including physicians, prescription guideline writers, payers and formulary committees, to effectively evaluate the appropriate use of a drug.
In conjunction with the publication of the pilot study, Bioethics International launched its Good Pharma Scorecard (GPS), a system designed to independently rank biopharmaceutical companies and new drugs based on key ethics, human rights, and public health criteria, beginning with R&D and clinical trial transparency. The novel framework has been developed over the last six years in collaboration with multiple stakeholders, and Bioethics International now is expanding the rankings to include drugs approved in other years as well as additional trial sponsors.
The organization plans to release those rankings annually with goal of improving biopharmaceutical company compliance with legal and ethical standards and the quality of medical knowledge.
“A critical issue facing the biopharmaceutical industry today is the loss of public trust,” said Jennifer Miller, Ph.D., president of Bioethics International, assistant professor of medical ethics in the Department of Population Health at NYU Langone Medical Center and lead author on the paper. “Only 17 years ago, the pharmaceutical industry was among the most admired business sector in the world, and today only 12% of Americans believe that pharmaceutical companies are honest and ethical. The Good Pharma Scorecard enables the biopharmaceutical industry to evaluate its performance across key areas of ethical and legal concern and offers companies the ability to publicly demonstrate meaningful improvement in trustworthiness over time.”
Arthur Caplan, Ph.D., professor and the founding director of the Division of Medical Ethics in the Population Health at NYU Langone Medical Center, said, “Transparency is a critical component of the ethical practice of medical research, and this ranking system has the potential to become a useful vehicle for change by outlining best practices and identifying areas that need improvement.”