Professor Rob Califf, Duke and former commissioner at the FDA recently outlined his thoughts on what the clinical trial space might look like after the Covid-19 pandemic. In the talk, Rob outlines the problems with doing large-scale trials and sets an optimistic tone on what might emerge after the pandemic. You can watch the full talk here.
Below are a few highlights of the talk:
“If we are going to treat people well and optimise their chances of a good health outcome, we need to have evidence that is high-quality that we can depend on. Otherwise, we are suffering from ‘eminence based medicine’ where doctors somehow think they know what the best thing is despite the absence of evidence.”
“In cardiovascular disease only 8.5% of major recommendations in clinical practice guidelines are based on high-quality evidence.”
“There are two options following the Covid crisis. We can either make the changes we need now to deal with the emergency hoping we can revert back to the ‘good old days’, or we can take the path of learning from what is happening now and implementing changes in the system that are permanent and move us to much more quickly to the system that is envisioned but not yet enacted.”
Rob Califf
“Clinicians involved in pragmatic trials don’t all have to complete GCP training”
Anonymous
“The value of randomization is undermined by poorly designed and underpowered trials”
Dr Fauci
The talk featured the RECOVERY trial run across the UK which is evaluating a number of treatments for Covid-19. In a recent talk for CTTI – which you can find here (the talk starts at 1:02), Professor Martin Landray presented some of the key findings that have already emerged from this ground breaking trial:
- Simple 2-page consent form
- Single ethics committee approval
- Simple 26 page protocol (which you can download here)
- 3 days to go from first draft to final protocol
- 5 days to get ethics committee approval
- 9 days to go from first draft protocol to first patient recruited
- 15 days to go from first patient to 1,000 patients recruited
- To date, over 7,000 patients randomised from over 160 hospitals
None of us know yet how things will be at the end of the pandemic. That said, perhaps, trials like RECOVERY – focusing on the fundamental principles to answer a question reliably and keep patients’ (and staff) safe – are giving us a glimpse of how trials might get done in the future.
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