EMA Calls for Coordinated Effort on COVID-19 Trials

Regulatory NewsRegulatory News | 19 March 2020 |  By 

The European Medicines Agency (EMA) on Thursday called on EU-based researchers to pool their resources to conduct large, multi-center, multi-arm clinical trials for potential treatments for coronavirus disease (COVID-19).
The agency says these studies “are most likely to generate the conclusive evidence needed to enable rapid development and approval of potential treatments,” but small studies and compassionate use programs may generate robust enough data to draw conclusions from.

The call comes one day after EMA and other health authorities, including the World Health Organization (WHO) and US Food and Drug Administration (FDA) held a workshop on facilitating global collaboration on vaccine development for COVID-19.
Specifically, EMA’s Committee for Medicinal Products for Human Use (CHMP) says randomized controlled studies featuring a control arm without antivirals or other experimental therapies would provide the most reliable evidence in support of an investigational product.
“Mutli-arm clinical trials investigating different agency simultaneously have the potential to deliver results as rapidly as possible across a range of therapeutic options according to the same evaluation criteria,” CHMP writes. The committee also calls for inclusion in all EU countries and says adolescent subjects be considered in adult studies.
The call for a coordinated approach comes as drugmakers and researchers around the globe scramble to develop treatments and vaccines for the virus. While the virus originated in China, Europe has become the epicenter of the pandemic, with major outbreaks in Italy, Spain, France and Germany, with the death toll in Italy surpassing China’s as of Thursday.
On Monday, Moderna began the first clinical trial for its mRNA vaccine for COVID-19 and this week China’s CanSino Biologics received the go-ahead to begin clinical testing of its vaccine candidate.
EMA says it is working with stakeholders to support the conduct of clinical trials for COVID-19 in Europe and that it will “support medicine developers with all available regulatory tools to advance and expedite the development of effective measures to fight and prevent the spread of COVID-19.”
Last week, EMA said it would waive fees for its scientific advice to developers of treatments and vaccines for the virus.
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) on Thursday also released its own guidance on how it plans to handle clinical trial applications (CTAs) for COVID-19.
“We have procedures for rapid scientific advice, reviews and approvals and are ready to support manufactures, researchers and other regulators,” MRHA says.
Companies wishing to submit a CTA to the agency are instructed to submit it both via the normal Common European Submission Portal (CESP) and directly to MHRA via its clinical trial helpline.
Similarly, the Danish Medicines Agency says it will prioritize “all requests regarding regulatory aspects in clinical trials” for products intended for COVID-19.


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