EMA has now set up an infrastructure to support the monitoring of the efficacy and safety of COVID-19 treatments and vaccines when used in day-to-day clinical practice. This is underpinned by three contracts for observational research that EMA has signed with academic and private partners over recent months, to be ready to effectively monitor vaccines in the real-world as soon as they are authorised, and support the safe and effective use of COVID-19 vaccines and medicines.
The latest contract was finalised in mid-July with Utrecht University and the University Medical Center Utrecht as coordinators of the CONSIGN project (‘COVID-19 infectiOn aNd medicineS In preGNancy’). This project will collect data on the impact of COVID-19 in pregnancy in order to guide decision-making about vaccine indications, vaccination policies and treatment options for COVID-19 disease in pregnant women. CONSIGN will analyse existing data sources (e.g. electronic health records, hospital data) and cohorts of pregnant women to provide information on the effect of infection and its treatments in different trimesters of pregnancy and on neonates. The project will be carried out in collaboration with the ConcePTION consortium which was established under the EU’s Innovative Medicines Initiative, the COVI-PREG project and the International Network of Obstetric Survey Systems (INOSS) network.
In June, EMA contracted the company IQVIA with a project to build a framework for the conduct of multicentre cohort studies on the use of medicines in COVID-19 patients. This project will include the identification of large national cohorts of COVID-19 patients and appropriate comparator groups, the development of a study protocol template for multinational studies as well as the establishment of a collaborative framework for researchers. The project will be carried out in collaboration with the European Health Data & Evidence Network (EHDEN) consortium, which was established under the Innovative Medicines Initiative and includes the Erasmus Medical Centre in Rotterdam and the University of Oxford as project lead and project coordinator, respectively.
In May, EMA commissioned the ACCESS project (‘vACcine Covid-19 monitoring readinESS’) 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 authorised.
Research using epidemiological methods on real-world data will provide additional information from clinical practice to complement data collected pre-authorisation through clinical trials and post-authorisation through the EU’s regular safety-monitoring activities.
Complementary to the contracts put in place, EMA is also contributing to COVID-19 work to strengthen methods guidance, transparency and international collaboration. Specifically, the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP), which is coordinated by EMA, has recently published the 8th revision of the ENCePP Guide on methodological standards in pharmacoepidemiology. It includes the contribution from 33 authors and 551 references to support researchers in generating reliable and reproducible evidence. The foreword to this revision highlights the importance of the guide for COVID-19 observational studies to provide valid results useful for clinicians and regulators, guiding the reader to the chapters that may be particularly relevant for such studies.
Observational research is an important pillar in the post-marketing surveillance of COVID-19 treatments and vaccines and EMA has called for transparency for protocols and results, as well as collaboration between researchers, to ensure high-quality, powerful studies. To facilitate this, ENCePP has set up a dedicated COVID-19 response group. EMA and ENCePP are encouraging researchers to register their pharmacoepidemiological studies (and make study protocols and reports public) in the European Union electronic register of post-authorisation studies (EU PAS Register), to ensure transparency on the various research efforts.
EMA is also fostering international collaboration on observational research through the International Coalition of Medicines Regulatory Authorities (ICMRA), with the agreement to step up cooperation in three areas: pregnancy research, building international clinical cohorts of COVID-19 patients and preparing a strong infrastructure for monitoring the safety and effectiveness of vaccines.
The outcome of the various projects conducted on observational research will be fed into the work of EMA’s COVID-19 EMA pandemic Task Force (COVID-ETF) and EMA’s scientific committees, to ensure that this evidence is translated into scientific opinions on the optimal use of the medicines and vaccines concerned.
