Expert: World failed in clinical research response during COVID pandemic

Recent reports from both the European Parliament and the WHO reiterate the need to update the regulations on medicines for children and orphan drugs in order to better address unmet needs of children and adolescents in cancer care. [SHUTTERSTOCK/Mongkolchon Akesin]

A new Lancet publication found that most European clinical trials were too small and did not provide meaningful results on the COVID-19 pandemic. According to one of the study’s authors, this showed how the world failed in clinical research response.

An article published in The Lancet Infectious Diseases on Wednesday (22 December) looked at how the clinical research community reacted to the pandemic in Europe.

It found that the research landscape was highly fragmented with few international
collaborations. Contracting, regulatory hurdles and competition with and between national trials were also significant challenges in the EU.

These factors combined meant that by October 2021, only a few studies had provided results of the required evidence level to formulate international treatment guidelines for COVID-19.

Herman Goossens, one of the study’s authors and professor of medical microbiology at the University of Antwerp, told EURACTIV that experts were working  “for many years” to prepare Europe for the next pandemic in terms of how to organise the clinical research response in Europe.

But despite having “everything in place” it all failed because of a lack of political leadership.

“The world just failed in terms of clinical research response, particularly during the first wave. There was no global leadership, there was no leadership in the European Union,” he said.

Multiple initiatives for evaluation of potential treatments for COVID-19 started at the beginning of 2020, “leading to a hugely fragmented trial landscape with few international collaborations,” as is stated in the paper. 

According to data from the COVID-19 TrialsTracker project, the number of clinical studies in COVID-19 up to 8 November 2020 was over 6400. A review of over 2000 registered trials of treatments for COVID-19 has shown that 95% were inadequately designed to yield actionable answers.

“Globally thousands and thousands of trials have been conducted that have not been completed,” Goossens said.

The reason – having unrealistic inclusion numbers “to justify trials”.  

“We call this academic cannibalism because a lot of researchers were fighting for the trials for the patients, and hundreds or even thousands of trials have been conducted with insufficient power to reach meaningful conclusions,” he explained. 

But competition among hospitals and clinical researchers is just a part of the story. 

“What I found most frustrating was the lack of collaboration between the member states and no support for the ministers of health,” Goossens said.

He gave RECOVERY – the trial done in over 175 hospitals in the UK –  as an example. It was “extremely successful” because “top-down, there was a clear message from the government, that this is the trial that we are going to support. This is a trial that if you do participate, you get funding.”

Support from the health ministers is not a silver bullet: “we need to create structures and partnerships in the European Union that facilitate the prioritisation of clinical research,” he said. 

MEPs demand active participation in HERA's governance

The European Parliament plenary voted on Thursday (11 November) for transparency, close cooperation and an in-depth review of HERA operations, aligning the new EU health emergency body with the future regulation on cross-border health threats.

How to strengthen the clinical research  

Goossens said that the preparations for the next pandemic must start now.  “We need to act now, […] because if we don’t have the clinical evidence to use certain drugs, patients are going to die.”

One suggestion is to build a European pandemic clinical research authority to “oversee pandemic preparation, clinical research response, and prioritise clinical studies.”

The authority should be advised by a pan-European board of clinical researchers with experience in running trials under difficult conditions, such as a pandemic, as is stated in the paper. 

But that will not solve all issues: “there needs to be a mechanism to rapidly leverage pandemic funding to conduct clinical trials. We need to invest in clinical trial networks, to build infrastructures, to build platforms for clinical trials.”

A lot is expected from the Health Emergency Preparedness and Response Authority (HERA). It is hoped that it will provide a platform to develop partnerships with member states and leverage funding during future pandemics. 

Last September, the European Commission launched the Health Emergency Preparedness and Response Authority (HERA), the new European health agency, to prevent, detect, and rapidly respond to health emergencies. It is expected to be fully operational in early 2022.

Last but not least, Goossens highlighted the importance of international collaboration. 

“Finally, Europe cannot do this on its own. So our clinical research response and clinical trial networks need to be embedded in a global response,” he concluded.

Health NGOs ask Commission to reconsider “crucial aspects” of HERA

Nineteen European health organisations have asked that HERA be more transparent, prioritise the public interest, and involve Parliament more in the decision-making process, in a joint letter published on Wednesday, 3 November.

[Edited by Gerardo Fortuna/ Alice Taylor]

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