Three researchers created a website earlier this year to name and shame pharmaceutical companies and universities in the United States that break a law that activists say is critical to patient safety. Now, the three have joined a few others to do the same for the European Union, creating a website that names 3,755 clinical trials—studies, done with human volunteers, of the safety and efficacy of new prescription drugs, vaccines, and medical devices—that have passed their deadlines for posting results publicly to the E.U. Clinical Trials Register.
"We do clinical trials to find out which treatments work best," says Ben Goldacre, a researcher who crunches medical data sets at the University of Oxford. He previously worked as a psychiatrist, hence the "we." "We cannot make informed choices with our patients, as doctors, unless we have the results of all the clinical trials that have been conducted on all of the treatments that we use."
At issue is a law in the U.S., and a non-legally binding piece of "guidance" in the E.U., that say organizations that run clinical trials must post their results publicly after a certain time frame. In the U.S., the data is supposed to go to ClinicalTrials.gov. In the E.U., it's ClinicalTrialsRegister.eu. The rules are meant to make it easier for doctors and researchers all over the world to look up data about how well drugs work. Trials often have their results published in scientific journals, but databases like the E.U. Clinical Trials Register are supposed to circumvent documented problems, such as companies not publishing certain trials, or journals rejecting studies that find treatments don't work, because such findings don't seem as exciting as positive news. Previous investigations have found that companies and universities regularly flout the U.S. law, which the Food and Drug Administration has never enforced. Goldacre's U.S. Trials Tracker tool has found that, to date, 41 percent of clinical trials that should fall under FDA reporting law haven't posted any results. The U.S. government could have levied more than $620 million in fines for late or non-existent results postings, but no one has ever been fined.
The new E.U. Trials Tracker shows that 49 percent of trials that the website's algorithm identified as being due for reporting have posted no results. Universities and other academic institutions tend to be worse offenders than pharmaceutical companies: 89 percent of non-commercially-run clinical trials have not posted the required data, compared to 32 percent of commercially-run trials. Goldacre's team hopes the public naming will encourage companies, universities, and the European Medicines Agency to act.
Maybe they will. "We welcome the publication of this study," Fergus Sweeney, head of inspections for the European Medicines Agency, said in a statement. "We at EMA are firm believers that transparency and public availability and scrutiny of clinical trial information and results are fundamental for the protection and promotion of public health." The agency is working on developing a way for Clinical Trials Register users to flag late trials, and a process for the agency to contact universities and companies when they're late, an agency spokeswoman, Sophie Labbé, wrote in an email.
Since Goldacre and his colleagues began publishing which organizations are late to posting their U.S. clinical trial information, however, they say the situation hasn't changed much. "Compliance rates have not improved for the FDA Amendments Act over the six months since we started tracking," Goldacre says.