‘Shocking’ MHRA Performance & Poor Data Transparency Blamed For UK’s Clinical Trial Crisis

While the UK’s drug regulator, the MHRA, has “pulled its socks up massively” in recent months, its poor performance was highlighted as a top cause of the UK’s faltering clinical trials ecosystem by a former health minister.

James O'Shaughnessy speaking at the Life Arc Translational Science Summit in April 2024
James O'Shaughnessy speaking at the Life Arc Translational Science Summit in April 2024 • Source: Pink Sheet

Lord James O’Shaughnessy, a former UK health minister and leader of a review into the country’s poorly performing commercial clinical trial sector, told attendees of the LifeArc Translational Science Summit on 23 April that a key contributor to the problem was the “performance breakdown of the MHRA,” which he said was “pretty shocking” at the time of the review, 18 months ago.

The UK saw a 44% decline in the number of UK patients recruited to commercial clinical trials between 2017 and 2021, something that prompted the government to commission O’Shaughnessy to...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Pink Sheet for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required

More from Europe

How Pharma Companies Can Mitigate The Impact Of US Tariffs On The Supply Chain

 
• By 

If US tariffs on pharmaceutical supply chain products come into force they could be disruptive for companies. Ewan Townsend, of the international law firm Arnold & Porter, explains how companies can mitigate issues through negotiating with suppliers and reallocating tariff responsibilities.

EMA Touts Faster Global Post-Approval Changes Via Regulatory Reliance

 

The European Medicines Agency says that a regulatory reliance pilot that it is supporting to speed up assessments of post-approval changes appears to be accelerating evaluation timelines in non-EU countries.

UK And US Regulators In Sync On RWD External Control Arms

 
• By 

The UK regulator’s draft guideline on the use of external control arms based on real-world data reflects concepts similar to those outlined by the US Food and Drug Administration.

New EU Approvals

 

The Pink Sheet's list of EU centralized approvals of new active substances has been updated to include two new products, one of which is Vyjuvek, Krystal Biotech's advanced therapy for treating dystrophic epidermolysis bullosa.

More from Geography

How Pharma Companies Can Mitigate The Impact Of US Tariffs On The Supply Chain

 
• By 

If US tariffs on pharmaceutical supply chain products come into force they could be disruptive for companies. Ewan Townsend, of the international law firm Arnold & Porter, explains how companies can mitigate issues through negotiating with suppliers and reallocating tariff responsibilities.

Japan Price Cuts For Epkinly and Lunsumio Following CEA

 
• By 

Japan is cutting more drug reimbursement prices following cost effectiveness analysis and is applying the methodology to a new group of products including Wegovy and Leqembi.