Amidst all the uncertainty about a COVID vaccine, at least this one thing is certain: it is changing how clinical trials are conducted.
Instead of taking years to move apotential vaccine from laboratory to trial, the US’s Operation Warp Speed has moved two of six prospective COVID vaccines into Phase 3 recruitment in under six months. Two more are expected to begin Phase 3 recruitment this month.
In the United Kingdom, a different type of clinical trial showed it is possible to enroll 12,000 patients, test several different existing treatment candidates and have the first significant results in fewer than 100 days.
Even given the substantial differences between the government-run health care system of the UK and the private, decentralized US system, there are lessons – “ideas,” Nicole Mather calls them in an article for the journal Nature – researchers here can apply to accelerate trials.
Describing how the UK’s RECOVERY trial went from concept to first, actionable results in such a short time, Mather identifies five differences with traditional trials:
- The trial protocol took only 20 pages to detail the design, and data and regulatory requirements. It was flexible enough to allow trial arms to be stopped or added.
- It got approvals in 9 days, versus the typical 30-60.
- Recruitment paperwork was simplified.
- Data collection and processing was accelerated through the UK’s DigiTrials hub, which provides centralized support for clinical trials.
- Results were quickly made public.
Though the RECOVERY program has its critics – objections center on releasing results without first being peer-reviewed and structural issues – Mather says it shows how a centralized health data system and a streamlined design and approval process can accelerate the timeline.
“We’ve gone so far towards managing risk that we’ve created layers of bureaucracy that absorb time and money, and, paradoxically, increase the risk that beneficial treatments are not tested,” she writes.
That view is echoed by Martin Landray, deputy chief investigator of RECOVERY, who said the way the National Institute for Health Research cut red tape was “fabulous.” “Many academic and commercial trials have accumulated so much extra baggage over the years, such as long case report forms and 10 page patient consent forms,” he said in an interview with The BMJ.
Digital entry for the RECOVERY trial made consent and subsequent data collection quick and simple, The BMJ article reports.
Leveraging data systems is an important lesson, says Mather, who is life-sciences lead at IBM Services in London, which was a partner in the DigiTrials project. Because of the UK’s National Health System, much information was already available for trial study patients, simplifying the participation process.
That would be a much greater challenge in the US because of its private medical system, although the strong push over the last decade to digitize medical records is making the portability of patient data easier.
The UK RECOVERY program has given momentum to accelerating clinical trial processes. To build on it, says Landray, “We now need to apply the lessons from this approach to other major health challenges such as heart disease, cancer, arthritis, and mental health.”