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Early drug trials for patients with severe illnesses

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Patients with severe illnesses and debilitating conditions will be allowed to trial new medicines before they become licensed, under new regulations announced the Department of Health.

The Early Access to Medicines scheme will allow patients who have no other treatment options to trial medicines as soon as the Medicines and Healthcare Products Regulatory Agency (MHRA) has said that the benefits of the medicine would outweigh the risks following an initial scientific assessment.

The scheme will be launched in April.

Alongside the Early Access to Medicines Scheme, the DH has also launched a bank of nearly 75,000 medical research volunteers so that researchers can recruit people with specific conditions and a family history of conditions into research and trials.

The BioResource project, funded by the National Institute for Health Research (NIHR) and led from Addenbrooke's Hospital, part of Cambridge University Hospital, will focus on heart disease, dementia, infections and rare disease and was developed as part of the UK's commitment to life sciences.

Health secretary, Jeremy Hunt, told BBC Radio 5 Live that drug trials already ‘take too long' and that this scheme would help to ‘streamline' trials. ‘The joy of what we're announcing is that it reinforces the licensing process because the data that we will gather on drugs, that we can make available earlier, will help us to license them more quickly — so we will get the double win of the drugs and they will get through the licensing process faster as we will have more information on how effective they are.'

When asked if he was worried whether some patients might be tempted to take risks with drugs that have yet to be licensed, he said: ‘No one should take risks with drugs that haven't been approved. This scheme is a way of getting approval for the early use of drugs that we are know are safe but haven't been through the full licensing process. But this is not an invitation for people to use any drug they want and the reason for the strict procedures is to protect patients from drugs that have been heavily advertised or promoted but haven't yet been authorised as being safe.'

Dr Ross Breckenridge, a consultant clinical pharmacologist and chair of the Use of Medicines Committee at University College London Hospitals, said: ‘This is a very interesting scheme, but it would have to be reliant on the evidence around the drugs. The only worry would be that the speed of access would overtake the evidence-based research.'

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