SoylentNews is people
SoylentNews
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: 2) by rleigh on Sunday May 03 2020, @05:06PM
That is very much in doubt. Most drugs fail clinical trials, and the urge to fast track stuff through is not borne out of logical thinking. It's borne out of the desire to be seen to be doing something, anything, even when this is known to be a counterproductive course of action.
We already know this. It's simple probability based on existing success rates.
Look at the various drugs that have been proposed. I've read very mixed things about them. Some apparently raise the chance of dying, so rather than helping, they are hindering. The only way to be sure is independent trials, to definitively show one way or the other if there is a quantifiable benefit. To act without full information can be worse than not acting at all.
Some things can be potentially fast-tracked. Off-label use of existing, approved pharmaceuticals, is one means. The safety testing is already done, and doesn't need to be repeated. You need to prove that it provides a quantifiable benefit for a new purpose. But the toxicity and side-effects should be well established.