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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: 5, Interesting) by Anonymous Coward on Sunday May 03 2020, @02:05AM (1 child)
Has Fauci been "pushing" this drug? I give him a lot of slack given the fine line he has to tread. He has to delicately caveat and temper false hope spouted out of the President, but do it in a way that doesn't embarrass him. Plus he is under tremendous pressure to "wrap all this up" and put a happy spin on everything.
By the way, I work in the Federal Government and every year I have to take an ethics training as well as file a financial disclosure form. Do you know how galling it is under this administration to sit through an ethics course and filling out my disclosure form when our "bosses" flagrantly ignore all of it without ANY repurcussions? It is pretty demoralizing, actually.
(Score: 5, Insightful) by hendrikboom on Sunday May 03 2020, @02:59AM
And that's how a culture of corruption gets established and propagates itself. By demoralizing the honest.