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With a major pandemic sweeping the world, the standard process of clinical trials for drug approval has come under criticism as a needless source of bureaucracy and delay. Drug discovery chemist Derek Lowe in a blog post explains how clinical trials for drug approval work and the reasons behind the various requirements that the FDA and equivalent organisations around the world generally put in place before approving a new drug. He explains how most of these apparently pointless bureaucratic hurdles are actually there to help protect the integrity of the scientific process and ensure that the human subjects undergoing the trials are treated ethically. While a case can be made for relaxing some of these safeguards, especially in this time of pandemic, it is probably not a good idea to do so without at least understanding what these safeguards are for.
Determining how much of a pharmaceutical is needed to prepare for the trial. Ensuring your are actually preparing just that drug and not a polymorph. Proper laboratory and manufacturing practices to ensure the desired drug is actually prepared without impurities and contaminants. Preparing a plan for a drug trial. Demographics — age, gender, weight, current medications being taken. Getting a representative distribution of these as participants. And there's much more.
(Score: 1, Interesting) by Anonymous Coward on Sunday May 03 2020, @06:13AM
I've defended the new Remdesivir results. There are key differences in that study compared to many others, but we will have to see the actual preliminary results before anything can really be said. With that out of the way, changing the primary measures happens in studies, especially switch a primary and a secondary. Now, they are correct that this is usually very suspicious because it suggests blinding has been removed or something else fishy is going on, but the preliminary results should give a much better picture of who, when, where, why, and how it was changed.
In addition, there are key differences in this study, according to the public information on it that we have, and ones like the Chinese one in the Lancet. For example, there is a large disparity in group sizes, comorbidity ratios, and other characteristics in the Chinese study that would favor the placebo group. It also had a relatively low statistical power.
To me, this whole thing reeks as the NIAID and the government in general being desperate to come up with something now. The existence of a known mechanism and these preliminary results are an interesting indication that there may actually be something there and is a stark contrast to what came before. When used on patients that aren't nearly as sick, this could be a veritable "miracle drug" such as they can exist. But it is too easy to take shortcuts under political and other pressure. This could just as easily be an ineffective and expensive dud or turn out to net-harm healthier people due to side effects or iatrogenic adverse events.