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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, Flamebait) by Anonymous Coward on Saturday May 02 2020, @11:25PM (2 children)
They need to be protected from unscrupulous snake oil peddlers, Fox News, and the President of the United States, Impeached
Because, yeah...fuck having any hope. You should be WANTING this shit to work. Yet you seem to have a different attitude on it. Why is that? Did your bitch lose the 'in the bag election'?
You have to look no further than the current accusation against Biden. We went pretty damn quick from 'believe all women' to 'welllll acccchtuuuuly'. That pretty much proves all of this histrionics has zero to do with actual issues. It is 'wah wah wah we lost'. Throw whatever shit at anyone. Make sure it sticks.
Impeached
And exonerated. For 'hey that looks like a crime look into it'. Sure do not see anyone pissed off what Biden and his son were up to. Even *if* Trump did something wrong, so did they. But lets not talk about that. It was just as BS as the one they did against Clinton.
(Score: 0) by Anonymous Coward on Saturday May 02 2020, @11:29PM (1 child)
> You should be WANTING this shit to work.
You proved his point - you're all stakeholders in the outcome and can't be trusted.
(Score: 0) by Anonymous Coward on Sunday May 03 2020, @12:34AM
Duh. That's why politics exists. We're all biased and is impossible to trust each other's motivations, so we have to conjuring's and try to figure out acceptable solutions.