How The UK Is Reinvigorating Its Clinical Trials Industry
Recruitment Has Declined Substantially Since 2017
In the year since the Association of the British Pharmaceutical Industry raised the alarm about drastically dwindling clinical trial recruitment numbers in the UK, the country has taken a number of steps to try to turn things around.
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UK needs to do more to address the current uncertainty among sponsors on how decentralized clinical trials can generate regulatory-grade data.
The Medicines and Healthcare products Regulatory Agency says it is in “everyone’s best interest” if clinical trial sponsors seeking UK approval for low-risk Phase III and IV studies make use of its new notification scheme that will cut the 30-day statutory evaluation timeline by more than half.
The Health Research Authority has developed UK-wide Quality Standards and Design and Review Principles to improve the information given to people who are invited to take part in research. Their use will become mandatory in December.