In a move likely to be observed closely by other countries, the UK’s ethics regulator has launched a pilot to reduce approval timelines for new clinical trials, building on the country’s medical research successes during the pandemic.
The pilot could inform efforts worldwide to improve the way in which medical research is regulated, in the wake of decidedly mixed international experiences with fast-tracking Covid research in the initial stages of the pandemic.
The media have largely focused on a very small number of success stories:
The pace at which Covid vaccine trials were started up, completed, and made their results public has been breathtaking
The UK’s flagship RECOVERY trial has generated valuable information about which drugs help Covid patients, and which do not, at record pace
Behind the positive headlines, the uncoordinated and rapid approval of thousands of Covid trials in many countries has led to immense amounts of research waste.
This figure has probably skyrocketed in the wake of the pandemic. Due to weak study designs, small participant numbers, non-standardised outcome measures, overlapping research agendas, and failures to make research results public, a large majority of Covid trials are likely to provide no valuable insights and end up on the junkyard of science.
Against this backdrop, the UK has emerged as a global leader in clinical trial regulation.
“The timescales have gone from months and years to hours and days, which is just phenomenal, and shows you what is possible”, a UK researcher noted last year.
In addition, the UK has invested considerable effort into ensuring that once clinical trials are completed, their results are made public. According to WHO estimates, around half of all clinical trial results still remain unreported; these trials make no contribution to science or to patient care.
Last year, UK became the first country worldwide to adopt a comprehensive national transparency strategy to ensure that all trials rapidly report their results.
The Health Research Authority, which oversees all Research Ethics Committees in the country, is now building on these successes by piloting a new approach that would reduce the statutory timeline for ethics review by 75%.
Lord Bethell, Minister for Innovation, said:
“The quality of our research into COVID-19 has proved vital across the world - from finding new treatments to bringing forward a vaccine – and the Covid-19 process has shown it’s possible to carry out a fast-track ethics review without lowering safety standards.
“Being able to apply this rapid innovation to research into other diseases will ultimately mean patients can safely access ground-breaking treatments more quickly.”
Till Bruckner, founder of TranspariMED, said:
“Faster is not always better. However, the UK’s experiences during the pandemic have shown that speed and quality are compatible if regulators work together to cut red tape without cutting corners. After the pandemic, we cannot return to business as usual, with some patients having to wait ten years or more for the results of potentially life-saving clinical trials to come in, and many results never being made public at all.
“Hopefully, regulators in other countries will closely study the UK model of combining speed and transparency with scientific excellence.”
More details on the UK’s fast-track research ethics review pilot can be found on the Health Research Authority’s website.
Later this year, the UK will additionally pilot a combined regulatory-and-ethics-approval application pathway for new drug trials.
TranspariMED will continue to track these developments, with the aim of promoting the international uptake of innovative models to promote transparency and accelerate and improve medical research.