Government efforts to focus NHS resources on a smaller number of well-designed clinical trials could inadvertently be contributing to a backlog of stalled medical research, and result in some important trials being scrapped, researchers say.
Their warning comes as a report outlines the scale of “research waste” that has occurred during the pandemic, with rampant duplication of scientific efforts and weakly designed clinical trials exposing millions of patients to unproven treatments, with little scientific benefit.
About £1bn of Department of Health and Social Care (DHSC) money is spent funding medical research each year through the National Institute for Health and Care Research (NIHR), which also supports those running clinical trials by providing additional staff, such as nurses, facilities and equipment.
When Covid struck, these staff and resources were largely diverted towards researching vaccines or treatments for it, while scientists working in other areas either put existing trials on hold, or struggled to recruit patients because of Covid restrictions or people’s fears about catching the coronavirus.
Now that some of those trials are starting up again, the DHSC has instructed NHS hospitals and universities to conduct a review of the clinical trials they sponsor and cull those that look unlikely to deliver, eg studies that are struggling to recruit enough patients, or are impractical due to the availability of staff.
“To ensure the NHS research system continues to recover from the pandemic, we have asked sponsors and funders to conduct a review of their research – focusing on studies that are most viable, which will give as many as possible the chance of succeeding,” the DHSC said.
But some have warned that the DHSC review risked creating further delays, and could result in some important studies falling by the wayside.
Nikola Sprigg, a professor of stroke medicine at the University of Nottingham, said: “It is a good idea in principle, but the process is taking so long that it’s leaving people in limbo, and causing extra delays.”
She is concerned that some studies that have failed to recruit enough participants could be judged as unviable by the review and have their funding withdrawn, yet they might have been more successful had they not been delayed.
“Often, some of the most important trials are the hardest ones to do,” Sprigg added. “I think there needs to be some kind of process to make sure really important questions, or potentially beneficial treatments aren’t discarded inappropriately.”
Dr Simon Kolstoe, a University of Portsmouth bioethicist who studies research waste, said: “This is a pragmatic decision, but it will be sad for a lot of fields of research, such as cancer research, where it looks like an awful lot of studies are going to have their funding pulled, perhaps rightly, because they’ve been paused for so long that they’re never going to gather all the data they need to produce meaningful results.
“The concern is that if they are not nuanced enough in how they do this, they may force studies to close which actually, if given a bit longer, would be fine.”
However, Till Bruckner, the founder of TranspariMED, which campaigns for greater transparency in medical research, described it as a bold step that “will greatly benefit patients and taxpayers”, citing the pandemic as an example of just how wasteful medical research can be.
According to a report published by TranspariMED and Health Action International last week, most clinical trials of potential Covid drugs focused on only a handful of treatment options, while inconsistencies in their design made it difficult to pool data from similar studies to calculate an overall effect. By October 2020, nearly a third of the 516 trials registered during the first hundred days of the pandemic had not recruited a single patient, the report said.
The UK’s recovery trial – the biggest randomised controlled trial of drugs against Covid-19 in the world – was a rare example of a study that delivered useful information through its flexible design, which enabled it to evolve as knowledge about the pandemic grew.
Bruckner said: “The UK’s outstanding Covid research programme clearly demonstrated the benefits of focusing NHS resources on a limited number of well-designed and well-resourced studies that rapidly show which treatments work and which do not. In contrast, the uncoordinated research chaos in most other countries produced virtually no useful evidence.”
The DHSC said every study should have a procedure to ensure the wellbeing of participants if it has to close early, as this is required as part of their authorisation by the Health Research Authority.