July 2021: Clinical Trial Data Reporting in EU Countries

In Europe, the enthusiasm for trials is not matched with a zeal for reporting the results to the public. Nearly 28% of completed European trials in the EU Clinical Trials Register (EUCTR) on 1 July—had not posted their results according to the latest data from the EU Trials Tracker, set up by U.K. researchers in 2018. Public research hospitals and universities are responsible for the vast majority of the lapses, which appear to violate European rules that require sponsors to post their results within 1 year of a trial’s conclusion.

Some researchers from public trial centers aren’t keen to disclose negative results and others believe publishing results in a journal fulfills the reporting requirement, even though journal articles can come years later and are often not made public. The Public Assistance Hospitals of Paris (AP-HP), the largest clinical trial center in Europe has reported results for just one of 35 trials completed more than 12 months ago, according to the EU tracker. More than 200 of the center’s trials are listed on EUCTR as ongoing, even though more than half of them began more than 10 years ago.

The current rules stem from 2001 European guidelines are considered as “soft legislation” and some nations seem to be taking advantage. According to current French regulations, there is no obligation to post results in the EU database, their priority has been to publish both positive and negative results in peer-reviewed journals. In the Netherlands, it is sufficient if sponsors post results in the Dutch trial registry, run by the Central Committee on Research Involving Human Subjects (CCMO). The CCMO website states that sponsors must also post results of medicines trials in the EU database, but Amsterdam University Medical Center (AUMC) does not follow that rule seeing any advantage in double registrations or in doubling researchers’ administrative burden.

Europe is getting more serious about enforcing the reporting requirements. Since the launch of the EU tracker in 2018, timely reporting of results has risen from 50% to 72% of completed trials. The European Medicines Agency (EMA) has stepped up reminders to trial leaders and has sent out about 30,000 reminders to overdue trial sponsors since 2018, another possible driver of improvement. Special notices go out for COVID-19 trials.

EMA’s new trial registry Clinical Trials Information System (CTIS) launch scheduled for Jan 2022 will eventually replace the EUCTR portal after a 3-year transition period and will end the tedious process of registering trials in each participating country. Sponsors will upload all trial data, from start to finish and the relevant national regulators will review the data before the information becomes public in one, linear, straight-through process. Once CTIS goes live, a 2014 European regulation will take effect, empowering national regulators in the European Economic Area to enforce the reporting of results. It will be for governments to decide how the national regulators should enforce reporting and what penalties they should impose for lapses.

Denmark, known for its vigilant regulation of drugs and trials already has a law that allows authorities to fine or imprison clinical trial leaders who do not meet deadlines for reporting results.

Additional details are found here.

July 2021: Russian Federation Regulatory Update

In Russia, the Registry of Approved Clinical Trials (RCT) is hosted by the State Register of Medicines. An update was posted on the State Register of Medicines notifying its users to change their passwords by 12 July 2021. This action has been undertaken to comply with the requirements of regulators in the field of information protection and prevent unauthorized access to resources of the information system.

February 2020: What’s New on EudraCT

EudraCT has posted below notification:

As of 1.2.2020, the UK is no longer an EU Member State. However, EU law still applies to the UK during the transition period.

The transition period began on 1 February 2020 and is due to end on 31 December 2020.