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Frieda ☆ 2012-02-28 00:18 (4822 d 19:48 ago) Posting: # 8171 Views: 5,363 |
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Dear All! May I pick your gut-feeling and/or experience on the following issue? Due to a protocol violation in the second period of a two period cross-over BE study, the results of the second period cannot be used and this study period needs te be repeated. The violation did not present any safety hazard. The original second period is ongoing and has a long sampling interval post-dose. Imagine that it is possible to do the paperwork in terms of amending the protocol to allow the second period to be repeated, make a new ICF, getting approval from the IRB, obtaining new study medication at the site on time, do you think the FDA will accept the outcome of the study in which the two arms are now the original first period and the repeated second period  .Or, imagine that it is not possible to do the paperwork on time, would it be acceptable to try to recruit the same subjects for participation in just one arm (repeat second period) and compare these results with the original first period. I know it is pretty optimistic to think that you can re-enter enough subjects for a second round.. Any thoughts or suggestions are very welcome, thanks in advance. Frieda |
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Helmut ★★★   Vienna, Austria, 2012-02-28 02:22 (4822 d 17:44 ago) @ Frieda Posting: # 8172 Views: 4,514 |
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Dear Frieda, welcome back to the forum!  ❝ May I pick your gut-feeling and/or experience on the following issue? I try not to think with my gut. ❝ Due to a protocol violation in the second period of a two period cross-over BE study, the results of the second period cannot be used and this study period needs te be repeated. The violation did not present any safety hazard. The original second period is ongoing and has a long sampling interval post-dose. My emphases. If you can’t use the data anyhow, why don’t you stop sampling at all? I think that both of your options should be possible. Of course the first one is preferable. In any case be prepared to answer nasty questions about the protocol violation. — 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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Ohlbe ★★★ France, 2012-02-28 12:40 (4822 d 07:25 ago) @ Helmut Posting: # 8175 Views: 4,465 |
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Dear Frieda, ❝ If you can’t use the data anyhow, why don’t you stop sampling at all? I fully agree with Helmut there... If you know you can't use the data in Period 2, continuing with blood sampling could be considered as unethical. And if you stop sampling, at least nobody can pretend that you repeated Period 2 just because you didn't like the results  Regards Ohlbe — Regards Ohlbe |
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Frieda ☆ 2012-02-29 19:00 (4821 d 01:05 ago) @ Ohlbe Posting: # 8191 Views: 4,384 |
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Dear Ohlbe, of course, but with the subjects being ambulant we had a tiny time window and wanted to explore any option to keep the subjects in the study, if they so wished. Thanks! Frieda |
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Frieda ☆ 2012-02-29 18:54 (4821 d 01:12 ago) @ Helmut Posting: # 8190 Views: 4,422 |
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Dear Helmut, I am amazed that you remember.. it must be 5 years since I last asked a question on this forum. Thanks for yor opinion, that was my idea too, but I have not personally come across such a situation yet (after 25 years in PK). Of course the sampling had to be stopped and it has been stopped. It is not my study but I am the PK-girl who is going to report it, so I volunteerd to ask on your form. The subjects were ambulant and we tried to find a possible way out, but to no avail. Best regards, Frieda |
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Helmut ★★★ Vienna, Austria, 2012-03-01 01:39 (4820 d 18:26 ago) @ Frieda Posting: # 8193 Views: 4,364 |
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Dear Frida, ❝ I am amazed that you remember.. it must be 5 years since I last asked a question on this forum. Your first question was quite interesting, so I remembered your name. Not five years: the answer is only two clicks away: Frieda ⇒ [ Show posts ]. ❝ […] I have not personally come across such a situation yet (after 25 years in PK). Me not either. Really nasty. ❝ Of course the sampling had to be stopped and it has been stopped. It is not my study but I am the PK-girl who is going to report it, so I volunteerd to ask on your form. The subjects were ambulant and we tried to find a possible way out, but to no avail. Good luck & heads up! — Dif-tor heh smusma 🖖🏼 Довге життя Україна! Helmut Schütz The quality of responses received is directly proportional to the quality of the question asked. 🚮 Science Quotes |
Ing. Helmut Schütz