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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: 2) by JoeMerchant on Sunday May 03 2020, @12:49PM (2 children)
In my opinion, the cure for most of these problems is transparency. When you get a "trial" run by another Raoult (and they are legion), with sufficient transparency in the process it can be called out for what it is, not only by competitors but also by watchdogs.
People complain that automation is taking away all of their jobs - I think there's a huge industry waiting to be born in "industrial monitoring" - just because it only takes 100 people to run an industry that supplies all the corn for a continent doesn't mean those 100 people are doing their jobs in a way that meets the needs, or wants, of the corn customers. I'm not saying the 10,000 people employed by the proposed continental corn monitoring congress should tell the corn producers how to do their jobs - not exactly - but they should be telling the customers / consumers how the job is being done and provide them with the option to source their corn from preferred suppliers. A billion corn consumers can easily afford the $1 per year it would take to pay 10,000 people $100K per year to diligently monitor and report on the corn manufacturing and supply channels, and each other. Same thing could/should be applied to pharma, energy, foods in general, etc.
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(Score: 2) by driverless on Sunday May 03 2020, @12:53PM (1 child)
In theory we're already doing this, it's called "taxes" and "government regulators", problem is that many of them have been captured by the industries they're supposed to be watching. It does work in some areas, e.g. water quality monitoring, and in some countries which take it seriously. Problem is that in the US too much government oversight is communism or socialism or something and so you can't have it.
(Score: 2) by JoeMerchant on Sunday May 03 2020, @01:32PM
In the med device industry, regulation is effectively forcing the companies to do it to themselves - what's lacking is transparency to the consumer level. The device companies employ legions of compliance officers who ensure legally compliant levels of documentation and traceability discoverable by regulator (government, or agencies mandated to exist by EU regulation) audit. What I'm proposing is greater transparency / exposure of this kind of information to the end users of the products - and shifting the reporting structure such that the "transparency officers" don't report to the same CEO who is bonused on quarterly profits.
As alluded to above, the EU regulators (ISO-9000 notified bodies and similar) are moving closer to this "monitoring by the people" model, but they still lack transparency to the consumers. Their scope of discovery is also tremendously restricted, the opposite of transparency. There's no reason that corporate internal financial details should be secret - following the money is often the most direct route to expose corruption.
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