New body should end bizarre paradox in medicine and make trials cheaper and easier to run
Very occasionally, a government will do something awesomely good. The budget contains plans for a unified Health Research Regulatory Agency to streamline the regulations on clinical trials, and so make them cheaper and easier to run.
It's motivated, disappointingly, by a desire to make the UK a more attractive location for commercial trials. But this is the first time a government has shown signs of seriously addressing one of the most serious ethical problems in medicine: the harm done to patients by ethics committees and regulators.
There is a bizarre paradox in medicine. When there is no evidence on which treatment is best, out of two available options, then you can choose one randomly and be subject to no special safeguards.
If, however, you decide to randomise and so generate new knowledge to improve treatments, then a world of administrative obstruction opens up.
This is not an abstract problem. Here is one example. For years in A&E, patients with serious head injuries were often treated with steroids, in the reasonable belief this would reduce swelling, and so reduce crushing damage to the brain.
But researchers wanted to randomise unconscious patients receiving steroids, or no steroids. to find out which was most effective. This was called the CRASH trial, a famously hard-fought battle with ethics committees, even though both treatments – steroids and no steroids – were in routine use. When approval was granted, it turned out steroids were killing patients.
Only a trial could give us this information. Head injury is common. Patients died unnecessarily while we waited for this trial to be approved.
But it wasn't just the delay to getting the trial approved. Many research sites insisted on getting written consent for randomisation from a relative because it was a trial, even though the treatments were exactly what the patients would have received in normal practice without consent. On average, treatment in these centres was delayed by 1.2 hours.
Does a delay harm patients? Of course. And this week, after a paper in the Lancet, for the first time we have quantitative data showing how patients are harmed by these delays.
The CRASH-2 trial showed that giving a drug called tranexamic acid reduces the number of deaths for trauma patients with severe bleeding in A&E. What's more, as you'd expect – as they're bleeding to death - the sooner it's given the better.
A one-hour delay while you get consent reduces the number of patients helped by tranexamic acid from 63% to 49%. This really harms those patients. More than that, if the benefits of a treatment are attenuated in a trial, because of a delay introduced by the demands of ethics committees, then the trial gives the wrong answer. We incorrectly conclude that an effective treatment is ineffective, and it is abandoned, when it could have saved lives.
These kinds of outcomes are disastrous. Furthermore, it has taken medical researchers to expose them. As the Lancet authors explain, with no small touch of huff: "The lethal effects we have shown might have been found decades ago had the research ethics community accepted a responsibility to provide robust evidence that its prescriptions are likely to do more good than harm."
Of course there is a role for ethics committees. Of course we don't want an army of Dr Mengele's let loose on patients. Of course there will be disagreement on details.
But I don't believe that most patients hearing the stories I've just told would welcome the acts of the ethics committees. The government's announcement this week should hasten change, and if you ever get sick, you might be grateful.