War in Ukraine may require significant trial changes, EMA says in new guidance
As the war in Ukraine rages on, the European Medicines Agency is looking to help sponsors of ongoing clinical trials navigate the disruptions that are expected to continue.
But the EMA isn’t ready to put together a one-size-fits-all approach for trials impacted by the ongoing conflict.
“At this point in time, it is not possible to provide general advice on how different aspects related to disruptions caused by the war in Ukraine should be handled, as implications on clinical trials are expected to be manifold,” the agency said in new guidance published late last week.
While focusing on estimands (i.e. hypothesized treatment effects), the new guidance notes that the emergence of new, unforeseen disruptive events may require the revision of the pre-specified estimand and/or the addition of estimands may be warranted. But any substantial changes in the design and conduct of a trial should be appropriately documented, and follow the local regulations.
Since the beginning of the conflict, 635 trials in various recruiting and enrollment stages were ongoing in the country, as pharma companies have also been providing aid to the nation while ceasing any trial activity in Russia.
The EMA makes clear that the safety of study participants is its top priority, regardless of any potential consequences for an ongoing trial.
When feasible, the guidance says that patients should be offered the option to continue receiving treatment even if this might require unblinding in the trial, although the EMA supports participants staying in the trial if this does not imply a safety risk.
While more severe disruptions are expected for scientists and companies operating in Ukraine, other countries are also expected to be affected in several ways, not just in the collection, analysis and interpretation of clinical trial data, but the arrival of refugees fleeing from Ukraine and the impact of imposed sanctions. The direct and indirect impact of war-related events on trial participants, sites and logistics is also likely to interfere with ongoing trials in several countries.
As for Covid-19 trials, the EMA encourages sponsors to consult the EMA’s previous guidance on Covid-19 and methodological aspects of ongoing trials. Likewise, it is recommended to seek scientific advice early in the process if substantial modifications to the current protocol or analysis plan are considered necessary.
Any aspects related to the impact of the war on trial design elements, recruitment, data collection, analysis and interpretation of results will be thoroughly reflected upon during requests for EMA scientific advice and the assessment of affected clinical trial data submitted to the EMA for marketing authorization, the guidance says.