Big pharma inconsistent with disclosure of information on clinical trials, new study finds

http://www.eurekalert.org/pub_releases/2015-11/nlmc-bpi110915.php

Public Release: 12-Nov-2015
Big pharma inconsistent with disclosure of information on clinical trials, new study finds
'Good Pharma Scorecard' ranks drugs based on their transparency and ethical practices
NYU Langone Medical Center / New York University School of Medicine

Despite legal and ethical requirements, information on clinical trials for drugs approved by the U.S. Food and Drug Administration (FDA) varied widely among some of the world's largest drug companies, according to a new study led by a researcher at NYU Langone Medical Center's Division of Medical Ethics in the Department of Population Health.

Although the lack of publicly available clinical trial information has been widely acknowledged as a decades' long problem, the researchers believe this is the first report that ranks specific drugs based on their sponsors' legally-required disclosure of clinical trial information and their ethical obligation to share information. The study, published online in BMJ Open also suggests that U.S. law is both narrow and unenforced in this area.

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"Selectively disclosing trial information can distort the medical evidence and challenge the abilities of physicians, prescription guideline writers, payers, and formulary decision-makers to recommend and provide the right drugs for the right patients," said Jennifer Miller, PhD, an assistant professor of medical ethics in the Department of Population Health at NYU Langone, and President of Bioethics International.

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The findings were sobering. Almost half of all reviewed drugs had at least one undisclosed Phase II or III trial. In addition, the investigators found that only 57 percent of trials per drug were properly registered; only 20 percent of final results were reported on ClinicalTrials.gov (a clinical trial registry and database maintained by the National Library of Medicine at the NIH); only 56 percent were published in academic journals, and; only 65 percent were published or had their results reported in some meaningful way.

Dr. Miller also noted that selectively disclosing information violates the rights of human research subjects laid out in the U.S. Common Rule, a rule of ethics that requires that human subject experiments have the potential to contribute to generalizable knowledge.

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