Trial Non-Reporting a European as Well as U.S. Problem

The Jan. 17 article in The Lancet about low reporting of U.S. clinical trials attracted attention in Europe too-and not just because the researchers were from Oxford University. Non-reporting has acquired a new and high profile in Europe, partly because of the European Medicines Agency’s (EMA) attempts to tackle the problem, and partly because of energetic social media campaigning. Since early in 2019, health campaigners in Europe have been publishing and publicizing similar failings among European researchers.

The Lancet article revealed that three years after U.S. obligations on publishing clinical trial results came into force, fewer than half of clinical trial results are reported promptly, and a third remain unreported. The findings also identified non-industry sponsors-universities, hospitals, and governments-as worse offenders than industry, with trials sponsored by the U.S. government least likely to post results on time.

To improve public disclosure and limit selective publishing of results, the U.S. Food and Drug Administration Amendments Act of 2007 required sponsors of most U.S.-regulated clinical trials to register and report results on ClinicalTrials.gov within 12 months of primary completion, irrespective of whether the results are positive or negative. In January 2017, clearer reporting requirements were laid down, backed up with fines of up to $10,000 a day for non-compliance.

But high rates of non-compliance persist, with more than 2,400 trials breaching the rules, and the study suggests that poor enforcement is to blame. The authors estimate that had the law been strictly enforced, over $4 billion in fines could have been collected up to the end of September 2019. But it says that progress has stalled, with the proportion of compliant trials stable since July 2018. One of the study’s authors, Nicholas DeVito, from the University of Oxford, said: “The fact that the U.S. Government cannot comply with its own laws is particularly concerning.”

In Europe, a highly critical report emerged in February 2019 alleging that academics were largely failing to report their clinical trial results in line with EU rules. The posting of all summary results in the EMA’s register, EudraCT, became mandatory for trial sponsors as of 2014-and the requirements will be reinforced when the EU’s clinical trial regulation comes into effect.

Most European universities were performing poorly, announced a health transparency organization, TranspariMED. The group’s head, Dr. Till Bruckner, said only U.K. universities had anything like a respectable record. Then in April 2019, a further report from a coalition of health campaigners said that fewer than one in five of academic clinical trials are being reported in line with legal requirements. Only 162 of 940 trials due to publish results had made their results public on the EU Clinical Trials Register. Rachel Cooper, director of Transparency International’s Health Initiative, described the figures for European universities as “shameful.”

As with the recent U.S. survey, European studies have shown that most major international drug firms scored well-mostly in the 80% and upwards range, with Bayer and Boehringer Ingelheim among those scoring 100%.

TranspariMED also released its own data on U.S. reporting in March 2019, which identified 25 leading U.S. universities that it said were violating medical research transparency laws. “Between them, these universities have failed to post the results of 140 out of 450 clinical trials subject to legal reporting requirements,” according to the report’s conclusions. And only 15 out of 40 universities assessed had duly posted the results of their trials onto a public database as required by law, the analysis showed. It pinpointed Columbia University as one of the worst culprits, since it had not posted the results of 83% of its trials.

But the follow-up in Europe has been striking, with a highly visible “name-and-shame” approach on social media, in which TranspariMED has been calling out non-reporting universities (and occasionally complimenting those that have raised their game) in an uncompromising manner. One of the most recent-and entirely typical-is this tweet of Jan. 17-the day that The Lancet published this new research: “Dear @BentHHoyre, @oslouniversity has failed to upload a single clinical trial result to the European database EudraCT. Reporting results there has been mandatory since 2014. Can you pls follow up?” That same day, TranspariMED publicly tweeted to Hans Kluge, the new director general of WHO Europe, observing that “Across Europe, 36% of all drug trials are still missing results on the EMA-run EudraCT trial registry, in violation of 2014 rules”, and adding a pointed reminder that WHO has consistently supported transparency in clinical trials.

The leverage that social media offers is interesting in this case because it uses transparency to highlight alleged gaps in clinical trial transparency. But it is also interesting in itself, as a possible harbinger of a more interventionist-and powerful-approach by health campaigners.

Peter O'Donnell is a freelance journalist who specializes in European health affairs and is based in Brussels, Belgium.