Lifesaving cancer drugs are set to be approved at a faster pace under a new plan to take advantage of Brexit freedoms.
Health Secretary Steve Berkeley will today announce a new fast-track process to cut through bureaucratic red tape and halve the time it takes to start a study.
Read here: Ben Habib on Brexit
Writing in the Telegraph, Mr Barclay and Mr Lane vowed to “break down bureaucracy” and said the changes were part of the biggest overhaul of clinical trial regulation for more than 20 years.
They went on to say that the changes took advantage of Brexit to enable a “complete overhaul of clinical trials regulation”.
“Medical advances now have vastly improved the prognosis for many of the most serious diseases. For example, your chances of surviving cancer are twice as great as they were 50 years ago,” Steve Barclay and Lane writes Dr.
“These medical advances would not have been possible without clinical trials.
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Barclay and Lane have vowed to “break down bureaucracy” and said the changes are part of the biggest overhaul of clinical trial regulation in more than 20 years.
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“In addition to giving patients faster access to cutting-edge treatments, we know that clinical trials lead to improved outcomes for all participants. They also bring significant investment into the economy. Masu.”
The Telegraph says more than 2,000 applications have been cleared from a backlog built up during the pandemic.
Earlier this year, the average wait time for an application process that normally takes just 30 days reached four months.
Before the reorganization, the MHRA approved around 750 new trials a year.
But since July, regulators have approved 2,200 applications.
Under the plan laid out today, the approval period for low-risk trials will be shortened to just 14 days.
These low-risk trials are classified as Phase 3 and Phase 4 trials, meaning the safety risks have already been tested.
Mr Barclay and Dr Lane added: “The MHRA has taken the opportunity of leaving the EU and is currently undertaking a complete review of clinical trials regulation, the largest in over 20 years. A number of changes will be introduced to streamline clinical trial approval and increase transparency using tape.
“These changes will solidify UK clinical trials as innovative, comprehensive and international, making the UK one of the best places for patients and researchers to conduct research.”
“This reform means moving from a ‘one-size-fits-all’ regulatory approach to a more flexible and risk-proportioned regulatory approach.
“This approach underpins a new streamlined scheme for the lowest-risk clinical trials. This is a test.”
“This will save valuable time that experts spend unnecessarily reviewing the lowest-risk trials, and mean around 20 per cent of trials can be started and run more quickly, helping UK patients It will give us faster access to potentially life-saving medicines.”
