Europe Moves to Make Drug Trial Data More Transparentby
Drug researchers in Europe would be required to publish results from all medical trials under a proposed law that the European Parliament will vote on Wednesday. The new rules are meant to curtail pharma companies from cherry-picking favorable studies to get new medicines approved.
The changes are part of an overhaul of Europe’s drug regulations years in the making. The law would require drug companies and academic researchers to register clinical trials in a public database, and publish the results after regulators rule on whether to approve the medication being tested.
If approved, the law would be a victory for the growing movement to make medical research less opaque. The AllTrials campaign founded in early 2013 has been pushing to make comprehensive data on drug testing widely available. AllTrials co-founder Ben Goldacre, a doctor and author, explained the problem in a 2012 TED talk:
If I conducted one study and I withheld half of the data points from that one study, you would rightly accuse me, essentially, of research fraud. And yet, for some reason, if somebody conducts 10 studies but only publishes the five that give the result that they want, we don’t consider that to be research misconduct.
As Goldacre pointed out, selective publication has real consequences for patients, doctors, and public health authorities trying to make decisions when much of the relevant data are hidden. A December report (PDF) by auditors for the British Parliament said incomplete trial data raised questions about the U.K.’s decision to stockpile tamiflu, a flu treatment made by Roche. “We were surprised and concerned to discover that information is routinely withheld from doctors and researchers about the methods and results of clinical trials on treatments currently prescribed in the United Kingdom,” the committee wrote in the opening line of its report. The country spent 424 million pounds—more than $700 million at today’s rates—on the drug to protect against a potential flu pandemic, despite the “lack of consensus” about its effectiveness.
The pharma industry has announced some measures to make drug test data more transparent. GlaxoSmithKline said in 2012 that it would make clinical trial results more widely available to scientists. GSK and other European drugmakers, including Roche, Sanofi, and Novartis, have agreed to make patient-level trial data available to researchers through a centralized website.
“The pharmaceutical industry is committed to, and delivering, increased sharing of its clinical trials data to advance public health goals and achieve the best end results for patients,” Richard Bergstrom, the head of the European Federation of Pharmaceutical Industries and Associations said in a press release (PDF) last week. American drug companies, too, have signed on to sharing more data in principle.
In the U.S., researchers have been required since 2007 to publish some results of trials of drugs with Food and Drug Administration approval within a year of the study’s end. Compliance has been dismal: Of 738 studies that were subject to the reporting requirements in 2009, only 163—or 22 percent—had published the results a year later, according to a 2012 analysis in the British Medical Journal.
The European Union’s proposed law would let countries fine companies that don’t follow the new rules on publishing data. Advocates for broader access will be watching to see how well drug companies comply.