Another Prod at Europe's Sluggish Progress on Registries

May 21, 2019
Peter O'Donnell
Peter O'Donnell

Peter O'Donnell is a freelance journalist who specializes in European health affairs and is based in Brussels, Belgium.

Applied Clinical Trials

New money is not going to solve problems when it comes to registries in Europe, Peter O'Donnell writes.

New money is being made available-as from today-for upping the game in Europe with registries, a long-lamented weakness in the European drug development environment. The European Commission is inviting applications for funding of up to $6 million for improving rare disease registries.

It's an open secret that progress in building and systemizing registries in Europe has been slow. As the European Medicines Agency itself has pointed out repeatedly, "the approach to registries is often suboptimal in scientific and resource terms.” Among the failings EMA has highlighted are inadequate use of existing disease registries with all the consequent inefficiencies, duplication of efforts, gaps between what regulators are looking for, and what registries provide. Most registries just can't talk to one another. Additional problems come from poor design, uneven data quality, and inconsistent data control.

The new money is not going to solve all those problems. EU spending on health is always limited, because of the limited powers over health in the EU treaties. Since each EU country remains responsible for health within its own borders, it is expected to cover the costs of providing health. EU actions are closely targeted on activities with a cross-border significance.

So the potential beneficiaries of these grants will be chosen from among the players in one of Europe's flagship health projects, the European Reference Networks. These 24 networks, each focused on a specific rare or complex disease, have been set up over the last three years to bring together expertise from across Europe, but are still lacking much of the infrastructure they need.

"Since 2018 they are developing their research capabilities," says the Commission in its announcement of the grant. "Patient registries belong to this development, enabling to build patients cohorts at European level to follow up the natural course of diseases with sufficient patients' data."

The grants are intended to enable building, upgrading, and linking registries, and making them interoperable. There is an emphasis on getting the new registries to meet clear norms. The funding is to support 'a comprehensive approach for rare disease registries' using already-specified standards and tools, and the invitation to apply insists on following certain principles. The supported registries must 'strengthen coordination and cooperation and develop synergies among the networks and their registries.' They must "build on existing tools and avoid doubling similar actions or activities". And they must "avoid the development of a variety of diverse, non-interoperable solutions." The supported projects 'must end with fully operational, interoperable and visible registries.' Cooperation with EMA 'can also be envisaged,' but there are no specific requirements on how the ERN registries projects should do so.

The call for proposals is open until September.

Meanwhile, EMA is pursuing its own program of encouraging registry development (did anyone say "coordination?") and is currently seeking comment on a document on methodological and operational considerations in the use of patient disease registries for regulatory purposes. This makes clear the differences between a registry and a registry-based study, "as they must be well understood to avoid confusion in concepts and methods," EMA says. Views can be submitted to EMA before June 30.

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