Life-saving cancer drugs are set to be approved at a much faster pace under new plans to take advantage of Brexit freedoms.
Cutting red tape, Health Secretary Steve Barclay will today announce a new fast-track process aimed at halving the time it takes to launch research.
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Writing in the Telegraph, Barclay and Raine said the changes were among the biggest reforms to clinical trial regulation in more than 20 years, as they pledged to cut red tape.
They went on to argue that the changes took advantage of Brexit and allowed for a complete overhaul of clinical trial regulations.
Medical advances now mean that prognoses for many of the most serious illnesses significantly improve the chances of surviving cancer. For example, they are now double those of 50 years ago, write Steve Barclay and Dr Raine.
These medical advances would not have been possible without clinical trials.
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Barclay and Raine said the changes were among the biggest reforms to clinical trial regulation in more than 20 years, and they pledged to “significantly reduce red tape.”
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In addition to accelerating patient access to cutting-edge treatments, we know that trials lead to better care outcomes for participants overall. They also bring with them significant investments into the economy.
According to the Telegraph, more than 2,000 applications have been cleared from the backlog accumulated during the pandemic.
Earlier this year, the average wait time for applications reached four months, compared to a process that would normally take just 30 days.
Before the shake-up, the MHRA would approve around 750 new trials per year.
However, since July the regulator has approved 2,200 applications.
Under plans presented today, the approval time for low-risk trials will be reduced to just 14 days.
These low-risk trials are classified as phase three and four trials, meaning the safety risks have already been examined.
Barclay and Dr Raine added: The MHRA has taken advantage of the opportunities presented by leaving the EU and is currently undertaking a total overhaul of clinical trial regulations, the most significant in over 20 years, which will see a plethora of changes introduced ranging from the reduction of administrative formalities to rationalization. trial approvals towards greater transparency.
These changes will consolidate the innovative, inclusive and international nature of UK trials, making the UK one of the best places in the world to conduct research for patients and researchers.
The reforms involve moving from a one-size-fits-all regulatory approach to one that is more flexible and proportional to risk.
This approach underpins a new, streamlined program for lower-risk clinical trials, that is, later-stage trials that meet a strict set of criteria, such as the absence of known safety issues with the drug studied.
This means we can save valuable expert time needlessly reviewing trials where risk is lowest and around 20% of trials will be up and running more quickly, giving UK patients quicker access to potentially life-saving medicines.
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