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June 10, 2022

Tighter European trial regulations likely due to Covid-19 research waste

With a number of Covid-19 clinical trials in Europe now considered as research waste, sponsors should prepare for more guidelines.

By Urtė Fultinavičiūtė

As the world enters the next stage of the Covid-19 pandemic, Europe is going through a reckoning on how Covid-19 clinical trials were run in the region in the past two years. Many Covid-19 trials in Europe, particularly in the non-commercial sector, were not properly registered, were needlessly duplicated in several countries, and patients diverted to studies with very little likelihood of producing clinically relevant data.

As an example, France and Spain have the most uncompleted single-country Covid-19 trials. France accounts for 32 and Spain with 22 single-country studies that were withdrawn, suspended, or terminated, according to GlobalData Clinical Trial Database. GlobalData is a parent company of Clinical Trials Arena.

In response, the European Commission is due to adopt an EU general pharmaceuticals revision in Q4 2022, which should include elements relevant to clinical trials, says Eoin Ryan, European region senior analyst within the life science group at GlobalData. While the trend is moving towards a tightening of regulations, Ryan notes it is yet to be seen how adopted reforms will mean for the industry.

While there has been research waste, this is not to say that European regulations did not support a rapid and safe development of Covid-19 vaccines and therapeutics, it’s just that resources would have been better allocated more effectively.

Policymakers will not shy away from making some fairly difficult decisions that the pharma sector might not like, Ryan says. On the flipside, the industry does want some clarity of what is expected from their clinical trials, he adds. Improving EU regulation standards can help ease trial set up and for sponsors run research in a cost-effective way.

Covid-19 trial duplication leads to resource waste

As some regulators and companies wanted to get the ball rolling on Covid-19 vaccine and drug development, this was at the expense of critically pointing at which clinical trials should be prioritised, Ryan notes. In the past two years, many Europe-based trials were not properly registered, failing to meet the gold standard of the ClinicalTrials.gov approach in the US. This resulted in inevitable research waste as many trials were duplicated in different countries.

Most European countries now realise there were elements of failure in the early stages of pandemic, Ryan adds. Steps have since been taken to ensure that clinical trials are registered correctly, and generated data is expected within a specified period after the trial has ended. But these steps could have been done in the past two years if they were enforced properly, he says.

On January 31, EU’s Clinical Trials Regulation (Regulation (EU) No 536/2014) was launched. Its clinical portal and database – Clinical Trials Information System (CTIS) – went live the same day. Both were designed to streamline clinical trial application, review, and supervision, and bolster transparency.

Spain is singled out

A report by the non-profit organisation Health Action International in the Netherlands highlighted the successes and failures of Covid-19 research in the past two years. While it does not spend much time congratulating the winners, it suggests that the UK’s clinical trial infrastructure and expertise built up over the years led to important Covid-19 clinical trials and results.

Spain was singled out because many patients were diverted into clinical trials that had very little likelihood of producing any serious or relevant data. The report notes that the Spanish Agency of Medicines and Medical Products authorised 123 Covid-19 trials by October 2020, and 20 of which investigated hydroxychloroquine with only one of such trial completed.

There are some clinical trials in Europe where their public protocols were not completed in English. Ryan explains that, while this is not a reason for trial failure, it made it more difficult to search the registries effectively.

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