Fair point, but a lot of the article talks about how many studies aren’t meeting all four pillars of clinical trial design - that’s where my issue comes in, I think reporting that X% of trials do not meet all pillars is a bad metric.
And, not all medications these days are pills or IV infusions - some medications and treatments, which are governed by the FDA, are more invasive and more complicated.
The consent process for clinical trials has a ton of guidance (ICH GCP), but the onus is on the clinical monitors and hospitals to make sure it’s done correctly. Many trials now generate supporting documentation in which hospital staff are required to describe the circumstances in which consent was acquired. If the documents are generated, then it’s auditable.
Things get a bit hairy when you look at trials in Alzheimer’s and other cognitive disorders, because the patient may not be coherent enough to withdraw from the trial. In those cases, a legal guardian is responsible for the decision.
Unfortunately, this was an issue before Trump and will continue to be one afterwards. Assuming there even is an afterwards…
The article brings up some great points, some of which that I, an industry insider, weren’t even aware of, especially the historical context surrounding the AIDS epidemic. I’ll jump into the thread to critique an issue within the article.
One of the four pillars recommended by the FDA (control groups) are great in theory but can lead to very real problems in practice, specifically within indications that have an unmet treatment need or are exceptionally rare conditions.
If you have a disease that is 99% fatal but has 0 standard of care treatment options, is it ethical to ask a participant to enroll in a clinical trial and potentially not receive the study treatment/be on placebo? Or, what if the trial involves an incredibly invasive procedure like brain surgery - is it ethical for people to do a placebo procedure? Food for thought - and an explanation for why so few trials meet all four criteria proposed by the FDA.
Happy to answer questions about the industry if anyone has them.
My favorite AI fact is from cancer research. The New Yorker has a great article about how an algorithm used to identify and price out pastries at a Japanese bakery found surprising success as a cancer detector. https://www.newyorker.com/tech/annals-of-technology/the-pastry-ai-that-learned-to-fight-cancer
Well shit. That makes a lot of sense.
No no, they listen. How do you think the “Hey Google” feature works? It has to listen for the key phrase. Might as well just listen to everything else.
I spent some time with a friend and his mother and spoke in Spanish for about two hours while YouTube was playing music. I had Spanish ads for 2 weeks after that.
I’ve raged and seethed about Neuralink so many times. There are so many obstacles needed to be overcome for a true Brain Computer Interface to work. Unless the company has magically solved some of the hardest problems in bioengineering, they’re just sacrificing monkeys for sport.
The Code of Federal Regulations (CFR) includes the laws governing the Food and Drug Administration. These laws are written in the blood of the exploited and vulnerable, like the victims of the Tuskeege Syphillis Experiment. Many of these regulations are specifically written to keep pharmaceutical and food companies from cutting corners in product development, testing, and manufacturing.
It’s not a necessary disruption. It’s going to kill a lot of vulnerable people.
Isn’t it magnesium chloride? More ions = better melting.
Please do not put ice salt on your food in a pinch
Oh neat, another brain implant startup. I published in this field. If anyone has questions, I’m happy to answer.
Good point, I’m assuming all monitors are as good as mine.