My cell provider claims I cannot bring my own phone into the plan and have to use one that they sell - anyone know if I can bypass the restriction?

Great, now I have to start proof-reading any communications I get from the FDA to make sure it didn’t hallucinate a scientific article in the citations. There’s going to be so many Vegetative Microscopy proposals.

If you’re working on a budget like I was when starting out on my own, I recommend your first purchase to be a bed frame. You can use Ceaigslist / FB marketplace to find some really cheap used options. From there, you can start buying (used) furniture that matches the bed frame. Personally, I needed a nightstand immediately after the bed frame because I wanted to put my glasses somewhere.

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.

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.

Option C: a shadow corp so big that different branches end up battling against one another without realizing it.