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The importance of equipoise in clinical research: https://www.nytimes.com/2020/08/05/magazine/covid-drug-wars-doctors.html Thanks @_tim_stephens for spotting. COVID-19 has brought this tricky conversation to the fore. Solutions are long overdue. @NIHRresearch @NIAAResearch @RCoANews @AAGBI @ICS_updates @FICMNews
Doctors' refusal to allow patients to be included in clinical trials is often represented as a safety concern. But does this make sense if thousands of patients are participating in the trial? Is this safety concern or doctors' prejudice?
On the other hand, the treating doctor DOES have a very important responsibility to advise their patient, and could not be expected to be familiar with the details of every randomised trial they might be eligible to take part in.
The problem comes when (a) clinical researchers fail to properly handle safety issues in their trials, or (b) doctors misrepresent clinical prejudice as safety concern.
Many researchers complain that regulations to guarantee patient safety in clinical trials are so strict they impede research. To meet strict regulatory requirements and then be accused of running an unsafe trial does make clinical trials much harder to deliver.
In some clinical specialities eg cardiology, cancer, the culture is to offer patients every opportunity to take part in research. This is also a stated objective of @NHSuk. But this not the case in every field, especially 'craft specialities' such as surgery and anaesthesia.
In the COVID-19 pandemic we were asked by @CMO_England @CMOWales CMOs of Scotland & Northern Ireland plus @NHSEnglandNMD to recruit to three key trials: REMAP-CAP, PRINCIPLE and RECOVERY. The latter has produced more robust findings than any COVID-19 trial worldwide.
This ability to prioritise key projects is only possible because of @NIHRresearch which has built superb research infrastructure unique to the @NHSuk. When call came the @NIHRresearch family answered. The findings of this work are saving lives worldwide.
...but the awkward truth is that not all @NHSuk doctors supported these trials. In some cases they wanted to prioritise their own research, but the main problem was equipoise. Some doctors felt sure they already knew the answers.
The subsequent findings of the RECOVERY trial in particular, have shown that many such doctors were simply wrong. They were either insisting on using ineffective treatments (eg hydroxychloroquine) or refusing to prescribe effective ones (eg dexamethasone).
In these cases, a major national trial supported by our most senior doctors is the ideal option. If we dont know the answer then offer the patient a place in a randomised trial. This offers the maximum chance of overall benefit to both the individual patient and society.
So where do we all stand on the ethics of refusing to allow patients access to randomised trials? Every trial is different so we cannot have a blanket rule but lets start with these major national priority trials: Is it OK to deny your patient a place on such a trial?
Very difficult questions. I dont suggest there are easy answers. But it is definitely time we discussed this more openly. Comments and questions welcome. @NIAAResearch and @POMCTN soon to launch a programme of work on this led by @mkphull and @katie_samuel_ amongst others.
