Over the last several decades, the Food and Drug Administration has allowed pharma companies to sell hundreds of drugs to patients without adequate evidence that they work and, in many cases, with clear signs that they pose a risk of serious harm.
Over the last several decades, the Food and Drug Administration has allowed pharma companies to sell hundreds of drugs to patients without adequate evidence that they work and, in many cases, with clear signs that they pose a risk of serious harm.
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.
Yes, though if the sponsor is doing it on the cheap then they might pick facilities and monitors who don’t care or don’t have the capacity to pick up on all the details, or scrutinise minutiae. The monitor can only QC what’s written down for example, and an investigator can be perfectly capable of having the bare minimum of a consent process and copy pasta as if it was done thoroughly.
I’m glad all my participants are of sound mind; the idea of navigating the world of incapacity and research gives me the heebie jeebies.
Good point, I’m assuming all monitors are as good as mine.
I wish all mine were as good as the best I’ve had.