The European Medicines Agency (EMA)—the regulatory body controlling drug rules in Europe—issued a press release announcing an agreement among drug regulators to cooperate on observational research (real-world data) focusing on medicines used in clinical practice centering on 1) pregnancy research, 2) medicines used in clinical practice, and 3) vaccine safety and effectiveness monitoring. An important topic as Real-world data (RWD) in medicine is data derived from a number of sources associated with outcomes in a heterogeneous patient population in real-world settings from not only clinical trials and health surveys to observational cohort studies. Observational in nature—as opposed to data collected in randomized controlled experiments—often data is obtained from electronic health records (EHRs), claims and billing activities, product and disease registries, and other sources.
Why is EMA making this announcement?
EMA and partners seek to leverage real-world data or aggregate real-world evidence relating to clinical practice in target populations in addition to analyses of ongoing randomized controlled trials. Of course, there is a growing consensus worldwide that such observational data complements traditional clinical trials to produce a holistic picture of the effect and safety of certain medicines and treatments.
US FDA Definition of Real-World Data; Real-World Evidence
Growing and important in the United States, the U.S. Food and Drug Administration participates with ICMRA. See the FDA’s description of this important topic.
Who are the key participants or collaborators?
The European Medicines Agency (EMA) and Health Canada came together to form the umbrella called the International Coalition of Medicines Regulatory Authorities (ICMRA). They came together on May 19, 2020.
Who are the participants in ICMRA?
See the list here.
What are ICMRA’s core focus areas?
As mentioned, there are three focus areas, including:
· Pregnancy Research
o Examine the impact of SARS-CoV-2 and medication use on pregnant women infected with the disease and on their unborn babies to support COVID-19 medicine development, risk management, and planning for safety monitoring of vaccines and therapeutics
· Building International Clinical Cohorts of COVID-19 Patients
o Share expertise and increase study power and data quality to meet regulatory requirements and address existing knowledge gaps.
· Prepare Strong Infrastructure for Monitoring Safety and Effectiveness of Vaccines
o Targeting COVID-19 to rapidly detect and minimize risks to patients.
Real-World Data Cooperation & Collaboration
Why not agree to study and share the observational data? Consisting of real-world data and all sorts of potential studies will help contribute to the COVID-19 response and establish the foundation for ongoing collaboration and data sharing for future crises.
Momentum from First Workshop
The parties are capitalizing on the momentum from a first workshop, involving participants from over 25 countries, representing 28 medicines regulatory authorities and experts from WHO, on COVID-19 observational research. During this event, participants stressed the need for regulators to cooperate and improve information sharing worldwide in relation to the research and development of treatments and vaccines targeting COVID-19.
Governance & Structure
Who are some Moderators?
Call to Action: Interested in learning more? See contact.