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RegisterApproved Pilot and Failed Pivotal Study [Study Assessment]
Hello.
There have been two strange similar cases recently where I work, and we have been discussing it for a while now. For both cases, a pilot study was conducted with 28 subjects, and bioequivalence was achieved through the 90% CIs (For drug A: Cmax 88.74% - 124.54% with ISCV of 36.88% and AUClast 87.10% - 113.39% with ISCV of 28.33%. For drug B: Cmax 89.34% - 119.35% with ISCV of 31.90% and AUClast 91.67% - 116.96% with ISCV of 26.64%). The sponsor could submit those studies to the regulator with no problem, but they haven’t done all the in vitro studies required. Based on the ISCV estimated on the pilot study they decided the sample size for the pivotal studies (64 for drug A and 56 for drug B). The problem is that the pivotal studies for both drugs failed (For drug A: Cmax 75.39% - 100.88% with ISCV of 52.49% (!!) and AUClast 72.70% - 87.57% with ISCV of 32.33%. For drug B: Cmax 74.01% - 90.26% with ISCV of 31.22% and AUClast 79.34% - 92.71% with ISCV of 24.26%). Same analytical methods were applied, the only thing that changed from pilot to pivotal was the sample size, and the batch of the reference in the study of the drug A.
What is to make of that? I mean, those products could have been in the market if the pilot study was submitted and a pivotal study was not conducted and I know that the results from the pivotal studies must be more reliable than the pilot's. How would we evaluate the reliability of the study?
Best regards.
Lucas
Edit: Category changed. [Helmut]
There have been two strange similar cases recently where I work, and we have been discussing it for a while now. For both cases, a pilot study was conducted with 28 subjects, and bioequivalence was achieved through the 90% CIs (For drug A: Cmax 88.74% - 124.54% with ISCV of 36.88% and AUClast 87.10% - 113.39% with ISCV of 28.33%. For drug B: Cmax 89.34% - 119.35% with ISCV of 31.90% and AUClast 91.67% - 116.96% with ISCV of 26.64%). The sponsor could submit those studies to the regulator with no problem, but they haven’t done all the in vitro studies required. Based on the ISCV estimated on the pilot study they decided the sample size for the pivotal studies (64 for drug A and 56 for drug B). The problem is that the pivotal studies for both drugs failed (For drug A: Cmax 75.39% - 100.88% with ISCV of 52.49% (!!) and AUClast 72.70% - 87.57% with ISCV of 32.33%. For drug B: Cmax 74.01% - 90.26% with ISCV of 31.22% and AUClast 79.34% - 92.71% with ISCV of 24.26%). Same analytical methods were applied, the only thing that changed from pilot to pivotal was the sample size, and the batch of the reference in the study of the drug A.
What is to make of that? I mean, those products could have been in the market if the pilot study was submitted and a pivotal study was not conducted and I know that the results from the pivotal studies must be more reliable than the pilot's. How would we evaluate the reliability of the study?
Best regards.
Lucas
Edit: Category changed. [Helmut]
Complete thread:
- Approved Pilot and Failed Pivotal StudyLucas 2014-03-17 15:27
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Approved Pilot and Failed Pivotal Study nobody 2014-03-17 16:02
- Approved Pilot and Failed Pivotal Study Lucas 2014-03-17 17:51
- Approved Pilot and Failed Pivotal Study nobody 2014-03-17 18:38
- Approved Pilot and Failed Pivotal Study Lucas 2014-03-17 18:55
- Approved Pilot and Failed Pivotal Study kumarnaidu 2014-03-18 05:03
- Approved Pilot and Failed Pivotal Study Lucas 2014-03-17 18:55
- Approved Pilot and Failed Pivotal Study - same test? Dr_Dan 2014-03-18 11:30
- Approved Pilot and Failed Pivotal Study - same test? Lucas 2014-03-18 13:38
- Approved Pilot and Failed Pivotal Study nobody 2014-03-17 18:38
- Approved Pilot and Failed Pivotal Study Lucas 2014-03-17 17:51
- Approved Pilot and Failed Pivotal Study Tina 2014-03-18 10:28
- Approved Pilot and Failed Pivotal Study Ohlbe 2014-03-18 11:15
- Approved Pilot and Failed Pivotal Study Helmut 2014-03-18 13:06
- Approved Pilot and Failed Pivotal Study Tina 2014-03-18 13:24
- Approved Pilot and Failed Pivotal Study nobody 2014-03-18 13:31
- Approved Pilot and Failed Pivotal Study Lucas 2014-03-18 14:03
- Approved Pilot and Failed Pivotal Study nobody 2014-03-18 15:55
- Approved Pilot and Failed Pivotal Study luvblooms 2014-03-19 05:16
- Approved Pilot and Failed Pivotal Study kumarnaidu 2015-12-08 07:02
- Approved Pilot and Failed Pivotal Study Lucas 2014-03-18 14:03
- Approved Pilot and Failed Pivotal Study nobody 2014-03-18 13:31
- Approved Pilot and Failed Pivotal Study Tina 2014-03-18 13:24
- Approved Pilot and Failed Pivotal Study nobody 2014-03-17 16:02
Ing. Helmut Schütz