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: 4, Interesting) by anubi on Sunday May 03 2020, @01:03AM (1 child)
I've always felt that responding with exactly as you see it, not what you think they want to hear, is in the long run the best policy, even if in the short run you have to find another job.
Office politics is a bear that i have never successfully fought.
Clinical trials take so long for the same reason I take so long. I want to make damned sure I don't release half baked work. Trouble is a lot of executive-class people demand half-baked work in the interest of quarterly profit goals and bonuses.
You sound like the kind of guy who is satisfied with nothing less than the best, lots of A's, Dean's List, and so on...and did your own work, not copy someone else's. Simply because you did not trust it.
It took lots of time to do it this way, but there is a comfort in knowing it's done right. It's tough for people of this mindset to subordinate to someone else who prides themselves in making the quick buck by cheapening the product.
Anyone think Elon Musk or Bill Gates would have made a decent employee?
Anyway, that's a great post, seen from the inside, of how half-baked stuff makes it out if proper checks and balances are not in place.
My hope is they run the clinical verifications, do it right, and give it to me straight...regardless of the outcome or investor interests.
"Prove all things; hold fast that which is good." [KJV: I Thessalonians 5:21]
(Score: 2) by JoeMerchant on Sunday May 03 2020, @03:54AM
I work for a big place now, and that's their HR approved messaging "from the top down," and, they're not wrong... even though human nature tends to avoid the confrontation in bringing bad news.
Yes, and no. If I won a major lottery, I'd probably devolve into perfectionism because I enjoy it. Back in the real world, doing the most good for the most people usually involves knowing when to cut and run, accepting the minor flaws for the greater good. That same big company takes mistakes very seriously and really strives to avoid embarrassment (which is horrible for innovation, we end up expanding/innovating by acquisition 90% of the time), but... they also develop and refine policies to review product and accept "acceptable imperfections" in recognition of the fact that a product that never ships never does any good for anybody, and we make stuff that's complex enough that it's never perfect.
🌻🌻 [google.com]