Submitting a pilot as a pivotal study [Study Assessment]
Hello all,
There have been a number of mentions on the BEBAC forums of using the results of a pilot to submit to regulatory bodies if the study "passes" without going to a pivotal. There are even arguments that it is not ethical to run a pivotal study if the pilot shows equivalence, i.e. why subject more healthy volunteers to a drug if not needed?
My question concerns what is required to actually successfully do this. How should the pilot protocol be written to allow this? Generally, pilot protocols do not have BE criteria specified. I presume this would be a requirement to convert a pilot to a pivotal? Do we need to put any additional text that mentions that if BE criteria are fulfilled no pivotal study will be conducted?
Secondly, is this not in effect cheating? If we use the pilot for submission when the study passes, then in effect we are giving ourselves an extra shot at passing. A free shot, since if the study fails to meet BE criteria we can just run a larger pivotal study that will narrow the 90% CI. The failed pilot will be submitted (with all other studies), but only for informational purposes, so it really has no impact on acceptance by the agencies.
Thank you.
Edit: Category changed. [Helmut]
There have been a number of mentions on the BEBAC forums of using the results of a pilot to submit to regulatory bodies if the study "passes" without going to a pivotal. There are even arguments that it is not ethical to run a pivotal study if the pilot shows equivalence, i.e. why subject more healthy volunteers to a drug if not needed?
My question concerns what is required to actually successfully do this. How should the pilot protocol be written to allow this? Generally, pilot protocols do not have BE criteria specified. I presume this would be a requirement to convert a pilot to a pivotal? Do we need to put any additional text that mentions that if BE criteria are fulfilled no pivotal study will be conducted?
Secondly, is this not in effect cheating? If we use the pilot for submission when the study passes, then in effect we are giving ourselves an extra shot at passing. A free shot, since if the study fails to meet BE criteria we can just run a larger pivotal study that will narrow the 90% CI. The failed pilot will be submitted (with all other studies), but only for informational purposes, so it really has no impact on acceptance by the agencies.
Thank you.
Edit: Category changed. [Helmut]
Complete thread:
- Submitting a pilot as a pivotal studylechia 2015-04-06 16:14 [Study Assessment]
- Submitting a pilot as a pivotal study Helmut 2015-04-06 19:24
- Submitting a pilot as a pivotal study ElMaestro 2015-04-06 19:46
- pilot ≠ pivotal study Dr_Dan 2015-04-07 11:43
- Submitting a pilot as a pivotal study Samaya B 2015-04-07 12:44
- Submitting a pilot as a pivotal study lechia 2015-04-09 18:01
- Submitting a pilot as a pivotal study Helmut 2015-04-06 19:24