January 7, 2016
By Alex Keown, BioSpace.com Breaking News Staff
JERSEY CITY, N.J. – The importance of clinical trial transparency took center stage recently during a leadership forum hosted by TrialScope, a company focused on clinical transparency management.
The issue of clinical trial transparency is an important one, particularly following the publication of a recent study in BMJ Open by Bioethics International that highlighted some of the issues of transparency. In its November report, which preceded TrialScope’s forum by a month, the authors allege Gilead Sciences, Inc. and Sanofi as among the worst industry offenders when it comes to transparency of its clinical drug trials. The report’s authors evaluated data from 15 drugs approved by the U.S. Food and Drug Administration (FDA) in 2012. The authors said there were wide variations on how much information was made public. According to the report, Gilead had the lowest scores of the companies reviewed. Researchers said Gilead disclosed 21 percent of the trial results for its HIV medicine Stribild. Sanofi‘s multiple sclerosis drug Aubagio also ranked low for publicly available information.
One of the key reasons for clinical trial transparency, Thomas Wicks, TrialScope’s chief strategy officer said in an exclusive interview with BioSpace , is the need to “promote the idea that if a trial has already been run by one company, then a similar trial won’t necessarily be run again by a different company evaluating the same criteria.”
TrialScope’s Clinical Trial Transparency Leadership Forum was designed to bring leaders in life sciences companies together to discuss and debate current and emerging clinical trial transparency and compliance topics, Wicks said.
“It will prevent needlessly putting patients at risk,” Wicks said.
Wicks’ sentiment is supported by the authors of the Bioethics International study.
“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,” the researchers said in a statement. Joseph S. Ross, associate professor of medicine and public health at Yale University School Of Medicine and an author of the paper, said medical decisions should be made based on all trial information, not only the information made public by drug companies.
TrialScope hosted the leadership forum in anticipation of a 2016 expansion of the FDA’s Amendments Act of 2007. The new rule clarifies requirements to clinical researchers for registering clinical trials and submitting summary trial results information to ClinicalTrials.gov, a publicly accessible database operated by the National Library of Medicine, which is part of the National Institutes of Health. A major proposed change from current requirements is the expansion of the scope of clinical trials that are required to submit summary results to include trials of unapproved, unlicensed, and uncleared products.
One area Wicks and Mike Forgash, the chief executive officer of TrialScope, want to see more transparency is with Phase I trials. Wicks said many of the Phase I patient trial data is never made public. Wicks cited the case of a German pharmaceutical company that conducted a Phase I trial and inadvertently exposed five people to a medication that caused organ failure. Although some survived the incident, they remain in poor health, Wicks said. A similar study took place more than a decade before that one and had those results been made public, Wicks said the German company would not have likely attempted to conduct the study.
While the Bioethics International study pinpointed Gilead and Sanofi as a transparency offender, Wicks and Forgash said there are some larger companies that have championed the idea, including Pfizer , Johnson & Johnson and GlaxoSmithKline . Those companies are “particularly public about their commitment to disclosure,” Wicks said.
Joanne Waldstreicher, chief medical officer of Johnson & Johnson, said the company believes sharing clinical trial data advances the science that is the foundation of medical care.
“Clinical trial data transparency is in the best interest of the patients who use our products and the providers who prescribe them,” Waldstreicher said in a statement.
