Government efforts to focus NHS resources on a smaller number of well-designed clinical trials could inadvertently contribute to a backlog of stalled medical research, and lead to some key trials being scrapped, researchers say.
Their warning comes as a report outlines the magnitude of the “research waste” that has occurred during the pandemic, with rampant duplication of scientific effort and weakly designed clinical trials exposing millions of patients to unproven treatments, with little scientific benefit.
Each year, approximately £1 billion of money from the Department of Health and Social Care (DHSC) is spent on funding medical research through the National Institute for Health and Care Research (NIHR), which also supports those conducting clinical trials through additional staff, such as nurses, facilities and materials.
When Covid hit, these staff and resources were largely devoted to research into vaccines or treatments for it, while scientists working in other fields halted existing trials or struggled to recruit patients due to Covid restrictions or people’s fears of the coronavirus. to walk up.
Now that some of those trials are starting again, the DHSC has ordered: NHS hospitals and universities should review the clinical trials they sponsor and abolish those that are unlikely to deliver, such as trials that struggle to recruit enough patients, or are impractical due to staff availability.
“To ensure that the NHS research system continues to recover from the pandemic, we have asked sponsors and funders to review their research – focusing on studies that are the most viable, giving as many people as possible the chance to succeed.” said the spokesman. according to DHSC.
But some have warned that the DHSC review risked causing further delays and could result in some key studies being missed.
Nikola Sprigg, professor of stroke medicine at the University of Nottingham, said: “It’s a good idea in principle, but the process takes so long that people are left in uncertainty and causing additional delays.”
She is concerned that some studies that failed to recruit enough participants will be assessed as non-viable and have their funding withdrawn, but that they might have been more successful had they not been delayed.
“Often some of the most important trials are the hardest to do,” Sprigg added. “I think there has to be some kind of process to make sure really important questions, or potentially beneficial treatments, aren’t thrown out 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 many areas of research, such as cancer research, where it looks like an awful lot of studies will see their funding pulled, perhaps rightly so, as they have stood still for so long that they will never collect all the data they need to produce meaningful results.
“The concern is that if they’re not nuanced enough in how they’re doing this, they could force studies to close, which really, if it took a little longer, that would be fine.”
However, Till Bruckner, the founder of TranspariMED, which campaigns for greater transparency in medical research, described it as a bold move that “will greatly benefit patients and taxpayers”, citing the pandemic as an example of how wasteful medical research is. could be.
According to a report published last week by TranspariMED and Health Action International, 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 trials to find a to calculate the overall effect. By October 2020, nearly a third of the 516 registered trials had not recruited a single patient during the first 100 days of the pandemic, the report said:†
the UKs recovery trial – the largest randomized controlled trial of Covid-19 drugs in the world – was a rare example of a study that provided useful information through its flexible design, allowing it to evolve as knowledge about the pandemic grew.
Bruckner said: “The UK’s excellent Covid research program has clearly shown the benefits of focusing NHS resources on a limited number of well-designed and well-researched studies that quickly show which treatments are working and which are not. In contrast, the uncoordinated research chaos in most other countries yielded virtually no useful evidence.”
The DHSC said any study should have a procedure in place to ensure the well-being of the participants if it needs to be closed early, as this is required as part of their approval by the Health Research Authority.
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