Brexit Boggles UK Trials
The number of clinical trials in the UK has plummeted amid growing anxiety over uncertainties linked to Brexit.
There were a total of 597 clinical trials conducted in Britain and Northern Ireland last year, a drop of nearly 25 percent from the annual average over the previous eight years, according to a new analysis by Fitch Solutions.
The UK is scheduled to leave the European Union in March and it’s unclear if European regulators will still accept data collected there after that deadline.
Without some kind of new deal in place between the UK and the EU, the UK will be treated as “a third country,” meaning its clinical trials will be subject to all sorts of EU regulations that wouldn’t otherwise apply.
That’s merely the tip of the iceberg.
Queens College, Belfast, in a recent report warned that a no-deal Brexit would have a “catastrophic” impact on the UK’s clinical trials sector, cautioning that it would complicate everything from immigration visas to European government funding for trials in Great Britain and Northern Ireland.
Nearly 20 percent of Queens College staffers, for instance, are citizens of EU countries and the European Union has given nearly $5 billion to support clinical trials in the UK since 2014.
Sponsors, many already skittish about Brexit, have become increasingly uneasy as the Brexit deadline approaches without a formal plan, prompting many to pause or pull the plug on planned trials, the Fitch analysis found.
For example, in late September, U.S. drug maker Recardio told Golden Jubilee National Hospital near Glasgow to stop recruiting patients for a clinical trial of its heart drug dutogliptin, citing fears about Brexit.
It’s a precipitous fall for UK sites, which were home to nearly one-third of Europe’s clinical trials in 2016, according to the latest UK government statistics.
And Brexit hasn’t just caused headaches in Britain and Northern Ireland.
Late last month, the European Medicines Agency issued a revised action plan for developing pediatric medicines. Several of the goals — including developing training for clinical trials from young people’s advisory groups — are officially on hold as the EMA moves its headquarters from London to Amsterdam in the wake of the Brexit vote.
Hoping to stanch the bleeding in advance, the UK-based clinical trials accrediting company IAOCR and Jonathan Sheffield, chief executive of the government-funded NIHR Clinical Research Network, recently issued a white paper urging the Tory-controlled government to fund “high throughput centers,” high-tech research institutes dedicated solely to Phase II and Phase III trials, with full-time ethics committees on staff to speed up trials.
To purchase a copy of Fitch’s analysis, email: email@example.com.