The results for nearly half of all clinical trials conducted by big drug makers during the last decade have not been published, and one company — Ranbaxy Laboratories — has not published findings for any of the nearly three dozen trials conducted in the past 10 years, according to a new online tool.
The tool was launched Thursday by AllTrials, a consortium of researchers and medical journals that has been pushing the pharmaceutical industry to do a better job of disclosing clinical trial data. This is an important, but also contentious, issue because without access to such data, independent researchers are unable to verify results that can lead to improved treatments, better health care, and lower costs.
The problem has not been confined to drug makers, though. An investigation last year by STAT found that many universities and medical centers, including some the most prestigious research institutions in the US, violated federal law by failing to report their study results to the ClinicalTrials.gov, the federal database that the new tool also sifts through for information.
“Everyone has been talking about this problem for far too long,” said Dr. Ben Goldacre, who is a founder of the AllTrials campaign, in a statement. “If any institution is concerned that it is doing badly in our tables, then there is one simple thing they can do: publish their trial results, using their trial registry number, so that this information can be accessed and read by doctors, researchers and patients.”
Who should take note? Well, the tracker found that Sanofi, for instance, had the largest number of missing trial results. There are 285 missing results from 435 eligible trials, which meant the company has not shared 65 percent of its findings, according to the tracker. Here is what a Sanofi spokesman sent us in response:
“In line with regulatory requirements and industry recommendations on voluntary disclosure, Sanofi systematically registers studies and discloses results on public registries, such as ClinicalTrials.gov and the EU-Clinical Trial Register. We also disclose certain results on our corporate website, in peer-reviewed medical/scientific journals and/or at medical congresses.”
Who else is a transgressor? Novartis did not disclose results for 201 studies, or nearly 38 percent of 534 eligible trials. And GlaxoSmithKline failed to release findings for 183 trials, or almost 23 percent of 809 eligible studies. We should note that the tracker, which includes trials completed between January 2006 and two years ago, only includes sponsors with more than 30 trials and excludes Phase 1 trials.
Drug makers are not the only culprits, though.
The tracker also found that the National Cancer Institute failed to report results for 194 studies, or nearly 35 percent of eligible trials. Meanwhile, the City of Hope National Medical Center in Duarte, Calif., was among the top five sponsors of clinical trials with the largest proportion of missing results — 39 of 44 trials, or 88 percent, went undisclosed.
Conversely, the tracker found that some companies have done a good job of publishing results. In fact, AllTrials noted that the top 20 trial sponsors with the lowest proportion of undisclosed findings were all drug makers. Leading the pack was Shire, which published all of the 96 trial results for studies run over the past 10 years.
This is not an academic exercise, by the way.
Numerous safety scandals erupted in recent years and ensuing litigation revealed trials results for some drugs were never fully published or disclosed. In response, AllTrials and others have pushed companies to make more detailed trial data available.
The effort prompted some drug makers to comply, although there is no uniform approach to disclosure. Last year, however, researchers sifted through newly released GlaxoSmithKline data for its Paxil antidepressant and found evidence contradicting the company’s published findings that the pill was safe and effective for youngsters.
I would like to know if there is any penalty for not publishing Clinical Trial result
Comments are closed.