Post by simonsays on Aug 13, 2021 4:14:33 GMT -5
Here's the issue I have with these companies. This is an investigational drug in Phase 3 trials, and the study has been suspended because the company discovered that the drug may cause some type of leukemia. (Also let's note that this isn't the first case of leukemia in a patient who's taken this drug, but that's another story.)
So anyway, they've cancelled the study. But what about the Phase 1 participants who have already been dosed, paid, and dismissed from the study? You would think that the right thing to do would be to tell them all soing like: Hey, you were in this study back in 2018. We've discovered that the drug may cause cancer. It's soing to be on the lookout for, because cancer usually is: (1) not detectable in its early stages, especially if you're not actively looking for it; and (2) much more easily treatable if it's caught early on.
You'd think that would be the least they could do. It wouldn't be that difficult for them. They literally have the name and address and phone number of everyone who participated in that study. (SSNs and birthdays, too). Sure, some people might have moved, but that's no reason to at least take the first steps to reach out to them. Heck, if they wanted to go even further, they could offer a free screening for all participants to compare their WBC counts today with what they were at the start of the study. But the least they could do would be to contact everyone.
I've done many studies and I've never received one of those phone calls from a clinic, or a sponsor, or a regulatory agency. I know that it's not standard practice, because when I screened for a study at Covance in Evansville (the same year that they closed), it was a study that my friend had just checked out of. The informed consent had just been revised to say that rats who had been given the drug had shrunken gonads, so they were giving the new informed consent to the participants who were currently housed at the clinic and to those who were screening for future cohorts. But my friend who had just finished the study and checked out a couple days earlier didn't receive this information.
Have you ever received any communication from a clinic about potential side effects that were discovered after your participation ended? Let me know in the comments. Don't forget to hit that like button. I'd say there are only a few things that I feel really NEED to change about Phase I studies, but this is definitely one of them. www.sciencemag.org/news/2021/08/gene-therapy-clinical-trial-halted-cancer-risk-surfaces
So anyway, they've cancelled the study. But what about the Phase 1 participants who have already been dosed, paid, and dismissed from the study? You would think that the right thing to do would be to tell them all soing like: Hey, you were in this study back in 2018. We've discovered that the drug may cause cancer. It's soing to be on the lookout for, because cancer usually is: (1) not detectable in its early stages, especially if you're not actively looking for it; and (2) much more easily treatable if it's caught early on.
You'd think that would be the least they could do. It wouldn't be that difficult for them. They literally have the name and address and phone number of everyone who participated in that study. (SSNs and birthdays, too). Sure, some people might have moved, but that's no reason to at least take the first steps to reach out to them. Heck, if they wanted to go even further, they could offer a free screening for all participants to compare their WBC counts today with what they were at the start of the study. But the least they could do would be to contact everyone.
I've done many studies and I've never received one of those phone calls from a clinic, or a sponsor, or a regulatory agency. I know that it's not standard practice, because when I screened for a study at Covance in Evansville (the same year that they closed), it was a study that my friend had just checked out of. The informed consent had just been revised to say that rats who had been given the drug had shrunken gonads, so they were giving the new informed consent to the participants who were currently housed at the clinic and to those who were screening for future cohorts. But my friend who had just finished the study and checked out a couple days earlier didn't receive this information.
Have you ever received any communication from a clinic about potential side effects that were discovered after your participation ended? Let me know in the comments. Don't forget to hit that like button. I'd say there are only a few things that I feel really NEED to change about Phase I studies, but this is definitely one of them. www.sciencemag.org/news/2021/08/gene-therapy-clinical-trial-halted-cancer-risk-surfaces
