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Regulatory Focus – Multinational efforts build framework for real-world and observational COVID-19 data

Regulatory Focus – Multinational efforts build framework for real-world and observational COVID-19 data

International regulators will increase cooperation for observational studies conducted in three key eras during the coronavirus pandemic.

Building a strong infrastructure to monitor vaccine safety and effectiveness, putting together international clinical cohorts of patients with COVID-19 infection and pregnancy research were identified as priority areas for cooperation during a workshop held 19 May 2020 under the umbrella International Coalition of Medicines Regulatory Authorities (ICMRA).

“Meeting participants agreed that global collaboration on observational studies of real-world data will help not only to contribute to the COVID-19 response but also to leave enduring legacy for future international observational research beyond the ongoing pandemic,” noted a press release from the European Medicines Agency (EMA), which organized the meeting along with Health Canada.

The vaccine monitoring infrastructure is aimed at rapidly detecting signals that could pose risks to patients and minimizing those risks.

Clinical cohorts of patients with COVID-19 that span countries will be important not just for increasing statistical power of studies and upping data quality, but also to allow sharing of expertise and resources, and facilitating meeting regulatory requirements and addressing existing knowledge gaps, according to the press release.

For the third priority, pregnancy research, international regulators will cooperate to look at how both COVID-19 itself and the use of any medications or treatments affects pregnant women and fetuses. These efforts, said the press release, will “support COVID-19 medicine development, risk management, and planning for safety monitoring of vaccines and therapeutics.”

The panel’s moderators were Marc Mes, the director general of Health Canada’s Marketed Health Products Directorate and Peter Arlett, who heads EMA’s Data Analytics and Methods Task Force.

The recent workshop was attended by representatives from more than 25 countries and World Health Organization experts and followed an April 2020 workshop that also focused on COVID-19-related observational research.

Recent US-based efforts to bolster real-world data collection and analytics include a partnership between that country’s Food and Drug Administration (FDA) and Aetion, Inc., a New York-based health technology firm. That agreement will use Aetion’s data platform to assimilate and analyze disparate real-world sources such as electronic health record data, insurance claims data, and existing patient registries.

Further support for collaborative use of real-world data comes in the form of a project that seeks to harmonize COVID-19 related data elements with existing common data models and other open standards. This project builds on work done by the Reagan-Udall Foundation-led COVID-19 Evidence Accelerator Collaborative Initiative, FDA, and Friends of Cancer Research. The project is maintaining a spreadsheet that maps common terms and data elements related to COVID-19, providing frequent updates to the living document.…