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Good practices

Race to report clinical trial results

New rules on disclosing the results of clinical trials in the European Union come into force on January 31, 2022. Universities and research institutions involved in testing new drugs will be required to declare the conclusions within set timeframes: no later than 12 months after the trial ends if the drugs are for adults, and within six months if they are pediatric drugs. To assess the extent to which scientists are preparing for the change, the Cochrane Library in Austria and nongovernmental organizations TranspariMED and Health Action International analyzed the transparency of clinical trials conducted by 26 major European universities and research hospitals and published a report on their performance.

The conclusion was highly positive. Twenty institutions were highlighted for their efforts to resolve pending cases and publish missing trial data. Together, they recently provided the results of 641 trials, equivalent to 28% of the backlog. The Medical University of Vienna, Austria, has reported the most trials to the European Union database, with 198 in total. In relative terms, it has published 96% of the required data. Next were Charité, a university hospital affiliated with Humboldt University and Free University Berlin, which provided 81% of its missing data; the Odense University Hospital in Denmark with 80%; and the Katholieke Universiteit Leuvenelgium in Belgium with 69%. “It is wonderful to see so many prominent European institutions, each responsible for more than a hundred trials of new drugs, uploading missing results,” said German political scientist Till Bruckner, one of the report’s authors and founder of TranspariMED, according to the organization’s website.

Progress, however, has not been uniform among all members of the EU. Italy and the Netherlands disagree on the delay in complying with the new rules. Recent data show that 90% of Dutch trials and 83% of Italian trials approved before 2015 have not yet reported results. The two nations are home to five institutions that have made no progress so far: the University of Groningen and Leiden University in the Netherlands, and in Italy, the National Cancer Institute in Milan, the Sant’Orsola-Malpighi Polyclinic in Bologna, and Gemelli University Hospital in Rome. The report had an instant impact. A day after it was released, the cancer hospital in Milan and the Polyclinic in Bologna, which is the largest hospital in Italy, both admitted there was a problem and announced that they would resolve the issue as soon as possible. Anyone who does not comply with the rules will be subject to sanctions by European regulatory bodies.

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