STAT News have reported on some early data from the Gilead remdesivir studies in COVID-19 patients.
Prof Stephen Evans, Professor of Pharmacoepidemiology, London School of Hygiene & Tropical Medicine, said:
“There are three Gilead sponsored studies on clinicaltrials.gov. One is the “trial” which has the leaked data in severe patients; a second “trial” is the same but in moderately ill patients and the third is their expanded access program, initial results of which were published in the NEJM. In each of these studies any comparisons of the benefits and harms of remdesivir rely upon external, non-randomised comparisons. These are always difficult to interpret, which is why in virtually all instances, medicines regulators require randomised comparison with current standard of care (including a placebo group in most instances for drugs). There are no “proper” RCTs listed with Gilead sponsorship which show an intention to demonstrate efficacy compared with a concurrent randomised group. It makes it very difficult to interpret, which is what is said in the article “The lack of a control arm in the study could make interpreting the results more challenging.”
“None of these studies is what should be done for a new treatment with unproven efficacy. They all depend upon non-randomised data for estimating efficacy. There is a danger that this strategy, of not using a randomised comparison group, could exert pressure on patients, health professionals and possibly even regulators to grant a licence for the product. It is going to be very difficult to begin a genuine RCT comparing current standard of care with remdesivir in the future, but there are several ongoing trials, not sponsored by Gilead, which are running currently. Provided Gilead has not restricted access to their drug for these trials and they have managed to recruit and follow up sufficient patients, we have the hope of finding whether remdesivir does have genuine efficacy and safety based on good evidence. Medicine is littered with instances where treatments were believed to have strong benefits based on non-randomised data (an example is the effect of combined hormone therapy on cardiovascular disease).”
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