WHO-coordinated super-trial has recruited just 1,900 patients in 12 countries so far
A flagship international clinical trial comparing four treatments for Covid-19 is being hampered by the time taken for gaining ethical and regulatory approval in different countries, according to its lead coordinator.
“We definitely see variation across countries in Europe regarding how speedy the process is,” John-Arne Røttingen (pictured left), chief executive of the Research Council of Norway and chair of the international steering committee for the Solidarity trial, told Research Professional News.
Even the fastest approvals have taken a couple of weeks to be approved, he said, adding: “Ideally, I think we should have tried to find a way to actually coordinate it better.”
Solidarity was launched by the World Health Organization on 18 March to bring together and strengthen the evidence from the large number of trials of potential Covid-19 treatments. As of 24 April there are 506 treatment trials planned, of which 278 are recruiting patients, according to a tracker endorsed by the WHO.
Røttingen said after a committee meeting on 29 April that so far about 1,900 participants across 12 countries have been enrolled in Solidarity. The WHO website says that as of 21 April more than 100 countries are participating, but Røttingen said “many of them will just have signalled a clear interest to join but have not started the processes of approval”.
About 15 countries are “in the pipeline of approval”, with others further behind, he said.
According to the ISRCTN (International Standardised Random Controlled Trials Number) clinical trial registry, as of 21 April the European countries recruiting patients to the Solidarity trial are Germany, Ireland, Italy, Norway and Spain.
Røttingen said that a European Commission ad hoc working group for Covid-19, which met for the first time on 17 April, includes a subgroup focused on better coordination of clinical trials.
“I think that is useful to improve both the speed of the processes but also coordinate decisions across European countries,” he said.
The first patient was enrolled in Solidarity in Norway on 27 March. Andreas Barratt-Due, who is co-ordinating the Norwegian wing of the trial, said recruitment is slowing due to the falling numbers of people being admitted to hospital with Covid-19.
“Altogether we have only included 100 patients or a little more,” said Barratt-Due. “The first phase of this pandemic is waning now, so with respect to that we are too late, in a way,” he added.
Røttingen said falling infection rates in European countries would have an impact on recruitment, but would be balanced by increased recruitment in other countries.
“That is also one of the positive sides of having the WHO Solidarity core protocol being run in many countries at the same time,” he said.