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COVID-19 treatment. How to improve quality of clinical trials? (9)
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Half of the clinical trial results are never published, as we have just discussed. Analysis of published data can be bent to the will of those conducting it. And you did a comprehensive analysis of clinical trial problems, including those selective reporting of the results. But what are overall the most common problems in clinical results in addition to selective reporting. The most common problems are where analysis itself has failed to look at the most important time scale. If we were to look at trials of surgery, and only look at the first three days, then all surgery would stop, because we know that there is operative mortality in some operations. There are rather higher rates of mortality around the time of some surgery than in others. But in virtually all surgery, there is a risk of death. But what you are looking for is a long term benefit. And so a lot of trials are not looking either at the long term to see whether there is really long term benefit, and maybe failing to see the harms that occur in longer-term. So that is a key problem in trials. There remains a problem obviously, of selective reporting, there can be a problem in selective analysis, the way that people do their analysis. Sometimes they do the really good and clever analysis to find benefits. And they do a crude analysis, one that is less likely to find evidence of harm. And so the balance between benefits and harms is often very bad. The most common problem, in the end, I think, is that the trials are too small. And they are failing to find evidence of benefit where there is some, and they’re failing to find evidence of harm where there is some. And so their results are just in the middle. And they because they’ve been too small. And that is a problem with drugs, with vaccines, with surgery with all kinds of treatments. Do you think then as a way to mitigate that problem or small trials because running clinical trials is very, very expensive, we need to rethink the structure of how medical practice is conducted and perhaps how the private and public payments for the clinical trials are shared. Because clear then becomes if the private industry pays for all clinical trials, you know, it really wants to see certain commercial results. That’s the reality of the world. And people might not necessarily benefit. How do you think the infrastructure of clinical practice overall and participation and trials should change in order for clinical trials to become more powerful? I think that the governance around clinical trials needs to be such that they are made much easier to do. I think that it is a scandal that in this pandemic, it has been entirely possible for a doctor to give letter say hydroxychloroquine or remdesivir, to individual patients with no checks whatsoever. None at all. They can just go ahead and do it. But as soon as They want to randomize, then all sorts of regulations come into play. And I think that it is unethical to go on treating patients where you do not know that there is benefit and failing to randomize in these circumstances. But I understand why that is. So, because the ethics committee the regulations around running trials have made that difficult and I think in a pandemic, we need to restructure the way we think and make sure that we randomized patients to treatment much more readily without requiring all the checks because patient, doctors are wanting to do their best for them. But they ought to ensure that when they do that, they are randomizing patients so that the data that comes out of the experience of their treating patients is able to be used in a valid way. At the moment, they can just go ahead and treat patients. And there are millions of patients who have had COVID-19. But only a tiny fraction of them have been put into randomized trials. So I think the regulation needs to be made a lot easier. And we need to train people on how to do simple trials. We need to make them much less complicated. We need to have incentives for people to do that and to do it while publicly funded, or at least not necessarily funded by the pharmaceutical industry. I think the pharmaceutical industry does very good trials. I think their interpretation is sometimes biased towards their business, but they generally conduct their trials very well. But there are a number of criticisms that can be made about their practices in the overall sort of trials they do. And in the trials that are interpreted to show their product in the best possible light. We don’t have nearly enough trials comparing two different treatments and the consequences that were much more uncertain about the comparative efficacy of medicines than we should be.
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