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YT ☆ Thailand, 2010-11-30 09:14 (5682 d 14:19 ago) Posting: # 6253 Views: 4,662 |
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Dear all, I would like to have some suggestion from here that if we found the blood withdrawal timepoint are not appropiate (less frequency or not cover 80% AUC 0-inf), after the clinical part is done. Can we terminate the current study before plasma analysis? And in what reason that sound reasonable enough for this termination. The data that made us make this decision are from our in-house recent study. Please suggest and thank you in advance. YT |
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Dr_Dan ★★ Germany, 2010-11-30 12:31 (5682 d 11:02 ago) @ YT Posting: # 6255 Views: 3,891 |
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Hi If you know, that you will not be able evaluate the study due to insufficiencies in study design it would be unethically to proceed. Therefore you have to stop the study immediately (no further blood draws) as soon as this information is available. There is no need to do the plasma sample analysis if you are convinced that the above mentioned problem will occur. If you have completed the first period but not started the second then you could run for an amendment repeating the first period with an adequate sampling schedule and proceeding with the second period (i.e. change from a two period study to a three way study). I hope this will help. Kind regards Dan — Kind regards and have a nice day Dr_Dan |
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Ohlbe ★★★ France, 2010-11-30 23:10 (5682 d 00:23 ago) @ Dr_Dan Posting: # 6259 Views: 3,898 |
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Dear YT, ❝ There is no need to do the plasma sample analysis if you are ❝ convinced that the above mentioned problem will occur. Well... I'm not sure I fully agree with Dan there. Even if you are 100 % sure your study will fail (wrong time points, wrong LLOQ) from experience gained during another trial, it would be a pity not to use some information you can obtain from this study: you can at least get Cmax (unless that's were you got your timing wrong !) and truncated AUCs, check the point estimate, the intra CV, and use it as a sort of pilot to power your new study - or reformulate if you see you have no chance. Regards Ohlbe — Regards Ohlbe |
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Dr_Dan ★★ Germany, 2010-12-01 17:20 (5681 d 06:13 ago) @ Ohlbe Posting: # 6262 Views: 3,828 |
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Dear Ohlbe To my understanding stopping a BE study means that the clinical part is running and you stop treatment and blood drawing. If you know at that time that you could not use the data then it is unethical to proceed. But in this case the clinical part was finished. This was my misunderstanding. Now it is the decision of the sponsor if he wants to pay for the information you suggested. As a sponsor I would demand to repeat the study with an adequate design on costs of the CRO and then it would be the decision of the CRO if these data are really needed. Kind regards Dan — Kind regards and have a nice day Dr_Dan |
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Ohlbe ★★★ France, 2010-12-01 19:20 (5681 d 04:13 ago) @ Dr_Dan Posting: # 6263 Views: 3,862 |
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Dear Dan, ❝ Now it is the decision of the sponsor if he wants to pay for the ❝ information you suggested. Agreed. ❝ As a sponsor I would demand to repeat the study with an adequate design ❝ on costs of the CRO and then it would be the decision of the CRO if these ❝ data are really needed. Really ? Well, I understand that the protocol was written based on available literature and that both sponsors involved accepted it as such... Unless you can demonstrate that other data published showed the sampling design to be inappropriate (and then it would be a pity not to have checked before approving the protocol), the CRO did not commit a fault which would justify doing the trial at their own expense, did they ? Regards Ohlbe — Regards Ohlbe |
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Helmut ★★★   Vienna, Austria, 2010-11-30 16:55 (5682 d 06:38 ago) @ YT Posting: # 6258 Views: 4,003 |
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Dear YT, ❝ [...] if we found the blood withdrawal timepoint are not appropiate ([...] not ❝ cover 80% AUC 0-inf), after the clinical part is done. Can we terminate the ❝ current study before plasma analysis? Stupid question: How do you know that AUCt < 80% AUCinf before analyzing samples and performing NCA? Divination (e.g., crystal ball, tasseography,...)?  — Dif-tor heh smusma 🖖🏼 Довге життя Україна! ![[image]](https://static.bebac.at/pics/Blue_and_yellow_ribbon_UA.png) Helmut Schütz ![[image]](https://static.bebac.at/img/CC by.png) The quality of responses received is directly proportional to the quality of the question asked. 🚮 Science Quotes |
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YT ☆ Thailand, 2010-12-01 13:00 (5681 d 10:33 ago) @ Helmut Posting: # 6261 Views: 3,854 |
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Dear Helmut, I'd like to explain about the situation. The problem was in the reference data of the reference product showed Tmax was around 1-2 hours. So the person (with less experience in this product) who developed the protocols suggested to design the blood withdrawal timepoint to be (0 hr) and at 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0,.. and so on. The protocol were developed in this manner for 2 sponsors together and both of them considered and came back with approval signature. After we conducted the first study and finished the plasma analysis, we found that the first timepoint after dosing the concentration were at the Cmax from almost all of the subject. Then we knew even the result is BE or not BE, we could not rely on it and the regulatory body will not accepted this result. This brought to my question for experienced person (include you, of course !!!) to teach me some suggestion for this scenario because we'd finished the dosing part of the second study and ready for plasma analysis. We think if we work on plasma analysis, the final result may come to the same situation with the first study. So we'd like to suggest sponsor to terminate the study and redesign the protocol to suit the PK characteristics found. Thank you for all comment YT |
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patilatu ☆ 2010-12-13 12:02 (5669 d 11:31 ago) @ YT Posting: # 6297 Views: 3,786 |
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Dear YT, I know one CRO where this type of study happened that after the completion of clinical part, the analysis started and after certain number of subject analysis was over they realised that the time points were wrongly selected. The study was stopped immidiately as the concentration pattern was highly erratic. better to avoid further loss of money. I fully agree with Dan as developing the protocol with this type of negligence is un ethical and we being a part of clinical research indusrty should not do that. |
Ing. Helmut Schütz