Good luck :-) [PK / PD]

posted by ElMaestro  – Belgium?, 2020-07-30 09:22 (91 d 00:32 ago) – Posting: # 21803
Views: 1,230

Hi VR,

» Really it was so interesting on every 5mins & 10mins blood collection, how team co-ordination works and also the study is mostly depend upon machine based algorithms (YSI Glucose analyser & software to calculate & output the clamp values), i found the clamp value was changing over each ysi glucose analyser though it is calibrated every 2hours.

This is one of the practical annoyances. The analyzers change all the time, there's heavy drift in its calibration and there is no obvious way to fix it during the clamp. Many have tried. :lookaround:
Add to that the clogging tubes everywhere....

» Man power is most needed to assist proper maintaining the clamp procedure.

Indeed, these must be some of the most labour-intensive trials.

» The nurse and phlebotomist has the major pressure on them, since they are in the blood collection and subject monitoring process.'

Plus the poor guy who is constantly screaming and kicking the YSI equipment. That guy will apply for early retirement after just a few trials, I guarantee it.

» Though i spent whole 24hrs in the study, i miss the rationale behind the study.
» which drugs need this glucose clamp study ?

You ask which studies "need" a clamp. That is not particularly well defined. At least not in a regulatory sense.
What I do know, is that ICH E6 §2.3 says:
"The rights, safety, and well-being of the trial subjects are the most important considerations and should prevail over interests of science and society."
The glucose clamp can handily keep the blood glucose above an unsafe low threshold. So any drug which lowers blood glucose -or which has the ability to do so at otherwise unethical/unsafe/dangerous levels- is a candidate for remedial action to mitigate the risk of hypo-events, and a euglycemic clamp is handy for that purpose.
There are other types of study, of course, where a clamp is handy to study the body's response to stimuli or lack thereof. Some clamps involve a peaking glucose, for example you may wish to study the body's own production of insulin/leptin/C-peptide/prostaglandins etc in response to a well-defined increase in glucose. A clamp-type of study is a good guess in such situations, since the increase in glucose is not so well-defined if you hand the volunteers a handful of Snickers bars or a gallon of Mountain Dew., :-)

I could be wrong, but...

Best regards,
ElMaestro

No, of course you do not need to audit your CRO if it was inspected in 1968 by the agency of Crabongostan.

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