Reforms to Approve New Drugs Faster in UK
The new reforms to the way medicines are tested could make the cancer drugs available faster.
To date, the new drugs had to go through a series of clinical trials to confirm their safety and effect in humans.
The proposals came following the Queen’s Speech that revealed the government’s plans to modify the laws on drugs that would improve the access to medicines post-Brexit.
The amount of time it takes to approve the drugs could be significantly reduced through the new trials called complex innovative design (CID) trials. This would expedite the availability of drugs to patients.
The CID would enable scientists to address multiple clinical questions at once through more complex trials. Drugs could be simultaneously tested for effectiveness and safety with different cancer types.
But running CID is more complicated and there are no practical guidelines available on how to run this test across Europe.
The experts, funded by the National Institute for Health Research and the health departments in Scotland and Wales, Cancer Research UK have called on clinicians. regulators and the pharmaceutical industry to support their proposals of reforms to approve new drugs faster.
Professor Pam Kearns, co-author of the paper and director of the Cancer Research UK clinical trials unit at the University of Birmingham said that it is their responsibility to bring novel treatments that are potentially more effective to the clinics as soon as possible and the new proposal will make sure that the good quality CID trials deliver this promise.
The Experimental Cancer Medicine Centre network consists of funders, academics, pharmaceutical industry representatives, patients, and regulators.
They proposed 10 recommendations that include better planning of trials, better statistical analysis, more involvement of patients, early involvement with regulators, and leadership and training for staff to deliver the trials.
“Doing more of this type of research in the UK would be a win for patients, industry and the NHS,” said Dr Ali Hansford, head of regulatory strategy policy at the Association of the British Pharmaceutical Industry and co-author of the recommendations.