European Medicines Agency says trial sponsors should be flexible on research plans
Organisations responsible for clinical trials of potential medicines that have been affected by the Russian invasion of Ukraine have been advised to use lessons learned during the disruption caused by the Covid-19 pandemic to adapt their research as needed.
Clinical trials often take place in medical settings, such as hospitals, which have been subject to attacks by Russia during its ongoing bombardment of Ukraine’s civil infrastructure and residential areas. Medical centres have also been inundated with the wounded (picture shows Ukraine’s president Volodymyr Zelensky visiting the injured in hospital).
“The ongoing war in Ukraine may require sponsors to adjust the way clinical trials are run in this region, and sponsors may need advice on how to deal with the impact of protocol deviations and other consequences of the disruptions,” the European Medicines Agency said on 30 March.
“Certain changes and protocol deviations in the current situation are unavoidable when, for example, scheduled study visits cannot take place, or arrangements need to be made to transfer trial participants who are fleeing Ukraine to other investigator sites of the same trial in the EU.”
The EMA, which regulates the approval of new medicines in the EU, said that adaptations will also be needed to protect trial participants’ rights and safety, and to ensure that the data collected by trials remain useful. It said that trial sponsors have already been asking for guidance on how to handle data.
“Where applicable, sponsors are advised to use the experience gained during the Covid-19 pandemic and apply the approaches and flexibilities agreed in this context,” the EMA said. It provided links to two documents with guidance on managing trials during the pandemic, which include suggestions around replacing site visits with remote communication, extending trials, slowing enrolments, closing trials sites and moving the locations of laboratory tests.
Meanwhile, the Health Research Authority, a regulatory body of the UK’s health department, said it would prioritise health research studies affected by the Russian invasion of Ukraine.
The authority said on 25 March that its “proven expedited review process can be used for urgent public health reasons, or if studies have been disrupted by world events. It was well used during the Covid-19 pandemic, when new studies were set up at short notice, or existing studies were amended to learn more about how to prevent, diagnose and treat coronavirus.”
On 24 March, the World Health Organization said that a month on from the start of the Russian invasion, the war had had “a devastating impact on Ukraine’s health system”. The WHO said it had verified 64 Russian attacks on Ukrainian healthcare services in 25 days, which it said caused 15 deaths and 37 injuries.
“Attacks on healthcare are a violation of international humanitarian law, but a disturbingly common tactic of war—they destroy critical infrastructure, but worse, they destroy hope,” said Jarno Habicht, a WHO representative in Ukraine. “They deprive already vulnerable people of care that is often the difference between life and death. Healthcare is not—and should never be—a target.”