UK plans to create comprehensive overview of all its clinical trials

The systems of the London-based ISRCTN clinical trial registry are being redesigned to provide a national overview of the UK’s medical research landscape, trade publication Pink Sheet reports.

“A fragmented disclosure landscape can hinder the ability to track, compare and analyze clinical research activity at a national level, reduce transparency for patients and the public, and complicate regulatory oversight and policy development,” the publication notes.

The ISRCTN registry is a globally recognized registry that is not run by the UK government. Rather, it is managed as an independent nonprofit entity. However, ISRCTN’s systems are increasingly being integrated with UK public data systems, making it the de facto national registry of the UK.

Key points from the Pink Sheets article:

• National overview. ClinicalTrials.gov will continue to be acceptable as a platform to register UK trials, at least in cases where U.S. law requires registration on the American registry (to avoid duplicate registrations). However, plans are afoot to make UK studies registered on other registries available on ISRCTN, thereby providing a comprehensive overview of all clinical trials involving UK patients. 

• Rapid results posting. ISRCTN is currently working on a form that will allow researchers to upload tabular summary results directly onto the registry. This will help sponsors to meet forthcoming UK legal requirement to make drug trial results public within one year of trial completion.

• More trials on ISRCTN. Currently only a quarter of UK trials are being registered on ISRCTN, but that proportion is rapidly rising. Most trials are still being registered on ClinicalTrials.gov. Both registries are equally acceptable to medical journal editors.)

• Transparency tracker. The registry plans to maintain its existing transparency dashboard, which provides data on how many trials have been pre-registered, reported results, and disclosed protocols and statistical analysis plans (snapshot below).

The continued reliance on ClinicalTrials.gov by sponsors in the UK and other countries may be risky, a recent blog from Canada has warned. It highlighted risks connected to the current U.S. administration’s perceived unpredictability and its unwillingness to continue to provide global public goods for free,