The European Medicines Agency (EMA) has set up new infrastructure to support the use of real-world monitoring of potential treatments and vaccines for COVID-19.
The infrastructure is supported by three contracts for observational research that the EMA has signed with academic and private partners, which will enable the effective monitoring of vaccines and treatments in real-world studies as soon as they are authorised.
The most recent contract, finalised in mid-July, was signed with Utrecht University and the University Medical Center Utrecht in the Netherlands for the CONSIGN project, focused on collecting data on the impact of COVID-19 in pregnancy. The project will utilise existing data sources and cohorts of pregnant women to gain information on the effect of COVID-19 infection and its treatments in different trimesters of pregnancy and on newborns.
Another contract, agreed in June, saw the EMA contract IQVIA to build a framework to support the conduct of multicentre cohort studies monitoring the use of a number of medicines in COVID-19 patients. The project will be undertaken in collaboration with the European Health Data & Evidence Network consortium.
In May the EMA also commissioned the ACCESS project for preparatory research into data sources and methods that can be used to monitor the safety, effectiveness and coverage of COVID-19 vaccines in clinical practice once they receive regulatory authorisation.
In March, the EMA called for a harmonised methodology for data collection across the EU to ensure that COVID-19 treatment and vaccine data can be easily interpreted by regulatory authorities and enable seamless approval. The agency had been concerned that individual, planned small studies would produce data without a robust clarity of efficacy against the disease.
The agency called for transparency surrounding trial protocols and results, and collaboration between researchers to ensure high-quality studies. To help facilitate this, the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP), coordinated by EMA, has created a dedicated COVID-19 response group.
The EMA is also fostering international collaboration on observational research through the International Coalition of Medicines Regulatory Authorities (ICMRA), focused on increased cooperation in three key areas: pregnancy research, building international clinical cohorts of COVID-19 patients and preparing a strong infrastructure for monitoring the safety and effectiveness of vaccines.