EMA proposes faster trial approvals during public health emergencies
European regulators want to streamline study authorization when health crises hit, learning from pandemic shortcomings that hampered research efforts.
At a Glance
- Draft rules would accelerate approval of studies addressing emergency and life-threatening conditions
- Guidelines emphasize well-designed trials over compassionate use programs for stronger evidence base
- Regulatory flexibility must balance participant safety with data integrity during health emergencies
Clinical trials could be green lit faster during public health emergencies under new draft guidelines issued by the European Medicines Agency (EMA). The proposals include regulations intended to accelerate the approval of studies “relevant to the emergency itself” as well as those “addressing other serious or life-threatening medical needs.”
The draft provides guidance on when trial participants can be transferred across investigational sites and when adapted procedures or alternative approaches may be required due to the specific challenges posed by public health emergencies.
It also encourages sponsors to contact the EMA’s Emergency Task Force (ETF) to ensure trials are efficient and capable of delivering meaningful data.
All trials—particularly those addressing public health emergencies—need to be well-planned and inclusive, according to the authors, who say studies during the pandemic were often less effective than they could have been because of design issues.
“A key lesson learned from the COVID-19 pandemic is that small, isolated clinical trials or compassionate use programs in individual member states may not generate sufficiently robust evidence for clear medical and public health recommendations. This underlines the need to prioritize the inclusion of trial participants in well-designed clinical trials over off-label or compassionate use in order to strengthen the scientific basis for decision making.”
The draft guidelines also acknowledge the need to balance regulatory flexibility that facilitates the generation of robust data with measures that ensure the safety of people taking part in studies.
According to the EMA, “Justifiable regulatory flexibilities need to be implemented to ensure that the safety of trial participants is prioritized, while minimizing risks to data integrity and reliability. These regulatory flexibilities must be counterbalanced by the foreseeable benefits to public health resulting from the clinical trials.”
The proposed guidelines, which are the first issued under the Accelerating Clinical Trials in the EU (ACT EU) initiative, are open for comment until the end of April.
