In March, as the tsunami struck Europe, it became clear that the virus could affect the United Kingdom’s National Health Service (NHS). To address this issue, colleagues and I remodeled the infrastructure so that clinical trials can safely obtain data about treatments from more patients more quickly.
This allowed the NHS to run the largest randomized clinical trial in the world – and to identify a treatment amid the heat of the pandemic, without bypassing regulatory processes. It was built on investments in programs and infrastructure established as a government strategy in 2017, when I was director of the Office for Life Sciences.
We worked nights and weekends to pivot NHS DigiTrials services – which was established in 2019 to plan for larger clinical trials – towards providing more types of information, including patient outcomes, and the ambitious RECOVERY Implemented new services for testing. The trial, based at the University of Oxford, aims to rapidly test a range of potential treatments for people who are ill. If such a treatment works, moving faster could save more lives.
On June 16, RECOVERY announced that dexamethasone, a commonly available steroid, could reduce mortality by up to a third in people with severe respiratory complications. Remarkably, this study covered 12,000 patients and 176 sites over a 3-month period. Looking back, I see ideas that could be widely implemented to speed up tests around the world.
The recovery test had five key features that set it apart from a standard approach. It had a short, flexible protocol – only 20 pages long – that stipulated the design and data and regulatory requirements, and allowed the interception or addition of test weapons. It received ethical and regulatory approval in just 9 days as compared to the standard 30-60 days. Its recruitment process was straightforward, with only a two-page consent form and a one-page bedside form to be completed by physicians. This accelerated data collection and processing through the NHS digitalis. And it quickly made the results public – preprinted on medRxiv servers and journal publication within a month after announcement (The Recovery Collaborative Group. n. eng. J. Med. http://doi.org/gg5c8p;2020) ).
What lessons can be applied to future examinations? How can we improve processes and leverage technology to accelerate findings, and do so without sacrificing transparency, patient participation and peer review?
First, streamline the bureaucracy. We’ve moved so far toward managing risk that we’ve created layers of bureaucracy that absorb time and money, and, paradoxically, increase the risk that beneficial treatments aren’t tested – or more likely to be. Even worse, ineffective treatments are widely used. ‘do something’. Clinical-trial protocols, ethical-consent forms, and patient-information sheets can run up to thousands of words. Review processes can take months, requiring different data sets and gradual approval.
There’s no excuse – we should narrow down the important questions to speed up the process. Some of the earliest lessons came during the Ebola outbreak in West Africa. During, and again during, Ebola, the UK Medicines and Healthcare products Regulatory Agency (MHRA) prioritized and processed clinical-trial applications within a week. Meanwhile, the Health Research Authority (HRA) reduced the average ethical-review cycle from 60 to 10 days.
In the long term, any prioritization approach requires careful consideration and consultation, but coordinating regulatory actions can expedite the process. For example, a jointly working pilot program launched in 2018, allows clinical-trial applications to be submitted for concurrent review by the MHRA and HRA.
Second, leveraged data systems. The RECOVERY trial benefited from a UK investment in the NHS health-data system. This includes the work of our NHS Digital team – a consortium of NHS Digital, my team at IBM, the University of Oxford and Microsoft. These data systems meant that only minimal demographic and consent data had to be collected at the patient’s bedside and then integrated with routine NHS information on treatment, diagnosis, testing, clinical outcome and survival.
Third, enable trust. This means accelerating research while having less opportunity to involve patients in the design and delivery of trials. As testing resumes, we must broaden efforts to include patients and the public. To build confidence in the use of health data for research, and to explain its potential to transform care, we need to work with institutions that the public has confidence in, such as charities or non-governmental Organization.