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In the Miami conference I attended back in June, I sat in on a session involving Phase I clinical trials. Our centre is trying to put together a Phase I unit in the not-too-distant future, and I thought it would be useful if I paid attention to some of the concerns.

This particular session involved an experienced Phase I research site talking about some of the things they had to do differently, as a result of the research being Phase I (as opposed to Phase II, III, or IV).

For interest, Phase I studies are the studies where the drug is tested in humans for the very first time. Drugs are tested on healthy humans specifically to look at how sick the people get with the drugs, what kinds of side effects they have, and in general, how toxic the drug is. Up until Phase I studies, the drugs will only have been tested in animals.

The thing that shocked me, was when the presenter said:

"Oh and if you have multiple research subjects, and you are batch dosing them, make sure you dose them at least 5 minutes apart. This way, if you have 6 subjects and they're dosed 5 minutes apart, in the event that they code and go into multiple organ failure 15 minutes post-dose, then you have time to: a) get the crash-carts ready for the subjects whom you've already dosed; and b) so you can stop dosing them and deal only with 3 dying patients rather than 6. One site had 20 subjects and dosed them 2 minutes apart. They all crashed at once. That's a lot to handle."

Noted.

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Comments

( 20 comments — Leave a comment )
synodalhaj
Aug. 25th, 2009 09:36 pm (UTC)
Why is this shocking? This seems really sensible. It might have been slightly shocking if it said something like "don't dose them all at once so that you can harvest their organs before the toxins irrevocably destroy them", or something more ruthless... but this protocol just seems like good advice based on the school of hard knocks. How is it any more humane or kind to stick your head in the sand and pretend that there's no risk to life in Phase 1 drug trials?
sharya
Aug. 25th, 2009 09:57 pm (UTC)
The part that made me blink was imagining the actions and logistics of dealing with 20 crashing individuals, or even that they would likely all crash at the same time post-dose.

In all of my studies, even the ones with regular and frequent Serious Adverse Events, they tend to not be dose/time-related incidents. Those ones don't get past the Phase I stage of testing. Which is why it never really occurred to me that you might have people crashing proportional to the time at which they were dosed - I just haven't had to deal with it.

The issue was surprising to me, because I didn't think of it. It makes me think of a whole lot of other scenarios to plan for which have also previously been a non-issue. The solution itself wasn't remotely surprising or shocking. Quite logical in fact. Although I think 5 minutes is still too frequent, depending on the number of subjects you're dosing.
synodalhaj
Aug. 25th, 2009 10:00 pm (UTC)
Aaaah... I get it. I misread your shock as some sort of bleeding-heart emotional kneejerk, when it was exactly the opposite. Dumb assumption! My mistake.
sharya
Aug. 25th, 2009 10:03 pm (UTC)
Me? Bleeding-heart? Tsk-tsk.

:P
synodalhaj
Aug. 25th, 2009 10:06 pm (UTC)
Exactly, that's why I was confused enough to reply :)
eviljenna
Aug. 25th, 2009 10:33 pm (UTC)
Your babies are really, really gorgeous.
sharya
Aug. 25th, 2009 10:54 pm (UTC)
Well hey you! Long time no see! And thank you :)

They're growing like little weeds.

How are you? How's Jayna? Actually, I will wander over to your journal and see...
sharya
Aug. 25th, 2009 10:58 pm (UTC)
Apparently I'm banned from your journal.

I'm so sorry to hear about your tough times though :/

My dad died last Sept. - Sept 11 actually. One year mark coming up. The pain isn't as sharp, but I still miss him just as much as I did when he died.
eviljenna
Aug. 25th, 2009 11:06 pm (UTC)
I don't actually know how to ban people... or how to unban. I'll work on that. I haven't updated much at all.

Jayna's fine, just started 10th grade. Or her ninth grade again, however you want to look at it.

Dad died in November and it still really really sucks.
sharya
Aug. 26th, 2009 05:17 am (UTC)
I can't really imagine losing so much family so suddenly... was your dad's death unexpected? I don't remember you mentioning that he was ill or anything...
eviljenna
Aug. 30th, 2009 08:57 am (UTC)
I left you a private message concerning this. Not sure if you received it or not.
eviljenna
Aug. 25th, 2009 11:13 pm (UTC)
Wow... there were a lot of people on that list. You're not one of them now. I'm not sure what happened there but now I understand why I stopped hearing from some old friends.
phaedie
Aug. 26th, 2009 12:38 am (UTC)
You're not a bleeding heart, all I could think was that the animals that were tested on probably had no crash carts waiting. :/
I'd suck at your job so much, I'd get mouthy and stupid. ;)
sharya
Aug. 26th, 2009 05:20 am (UTC)
Fortunately almost my entire job involves dealing with people via email or on the phone. It would be much more difficult for me to hide the fact that inside I was screaming at them, if I actually had to see them face to face!

That's why I got out of research and switched to human stuff... I know the animal research is necessary, but I couldn't stomach it.
2kidsdad
Aug. 26th, 2009 01:47 am (UTC)
Yeah, sign me up for mass organ failure! I'll go first thanks!

;)
sharya
Aug. 26th, 2009 05:21 am (UTC)
LoL aww <3
(Deleted comment)
sharya
Aug. 26th, 2009 03:57 pm (UTC)
Hehe yeah. It's one of the side-effects of working in the field - you get very clinical and non-emotional about things that would normally be at least a tiny bit upsetting.

I have to admit: my first thought when I heard her say that was, holy crap - that's a lot of lives to save all at once. My second thought was, holy crap, imagine the paperwork!

Occupational hazard I guess. When I hear about Serious Adverse Events, I am immediately picturing all the paperwork I'll have to do, to address the issue.
crak
Aug. 27th, 2009 11:03 pm (UTC)
That is both awesome and freaky at the same time. Yay science!
sharya
Aug. 28th, 2009 04:58 am (UTC)
I thought so too!
( 20 comments — Leave a comment )

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