Log in
RegisterStudy conduct in groups [Design Issues]
Hi Smitha,
That's an interesting question. At least, I never gave it any thought, but of course that doesn't mean much.
If I get you right you are asking if you you need 40 signed ICF's before dosing your first subject. No guideline discusses it, I think.
I can't offer an answer, but I think I would play it safe. In a trial with 20 subject and 2 backups you would ordinarily have all 22 ICF's signed before the first subject is dosed. If the backups are needed the trial is in a sense having two groups, right? Only the second group is rather small, but in a sense it serves the same purposes: getting the desired number of subjects.
Also if you start a study when 20 ICFs are available and you cannot execute group 2 because you for some reason are running out of eligibles then all manners of GCP hell could ensue. Thus, I am leaning towards treating 20+20 like 20+2.
This is just one opinion and not a very qualified one. I hope others will chime in as I believe there might also be arguments for doing it the other way. So I will go make some popcorn and will watch this thread with interest.
❝ If a Bioequivalence study has to be conducted in 2 groups (say 20 volunteers each), does the FDA or EMA require that all 40 volunteers be recruited into the study before Group 1 Period 1 dosing? 
That's an interesting question. At least, I never gave it any thought, but of course that doesn't mean much.
If I get you right you are asking if you you need 40 signed ICF's before dosing your first subject. No guideline discusses it, I think.
I can't offer an answer, but I think I would play it safe. In a trial with 20 subject and 2 backups you would ordinarily have all 22 ICF's signed before the first subject is dosed. If the backups are needed the trial is in a sense having two groups, right? Only the second group is rather small, but in a sense it serves the same purposes: getting the desired number of subjects.
Also if you start a study when 20 ICFs are available and you cannot execute group 2 because you for some reason are running out of eligibles then all manners of GCP hell could ensue. Thus, I am leaning towards treating 20+20 like 20+2.
This is just one opinion and not a very qualified one. I hope others will chime in as I believe there might also be arguments for doing it the other way. So I will go make some popcorn and will watch this thread with interest.
—
Pass or fail!
ElMaestro
Pass or fail!
ElMaestro
Complete thread:
- Study conduct in groups Smitha 2015-02-02 04:21
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Study conduct in groupsElMaestro 2015-02-02 08:21
- Study conduct in groups Helmut 2015-02-02 13:08
- Study conduct in groups Smitha 2015-02-04 04:30
- Study conduct in groups Helmut 2015-02-04 12:57
- Study conduct in groups felipeberlinski 2015-02-04 22:36
- Study conduct in groups ElMaestro 2015-02-04 23:58
- Significant ≠ relevant Helmut 2015-02-05 00:49
- Significant ≠ relevant Astea 2016-03-24 20:10
- Significant ≠ relevant ElMaestro 2016-03-24 23:12
- Significant ≠ relevant zizou 2016-03-25 21:41
- Loss of power etc. Helmut 2016-03-26 14:46
- Loss of power etc. Astea 2016-03-27 21:18
- Loss of power etc. zizou 2016-03-27 23:44
- Combined power? Helmut 2016-03-28 14:29
- Loss of power etc. Astea 2016-03-28 23:57
- Loss of power etc. ElMaestro 2016-03-29 00:16
- Mystery Helmut 2016-03-29 17:28
- Back to the Future Astea 2016-03-29 21:57
- Back to the Future ElMaestro 2016-03-29 23:11
- Using lectures != Reading them mittyri 2016-03-30 00:17
- Back to the Future ElMaestro 2016-03-29 23:11
- Back to the Future Astea 2016-03-29 21:57
- Loss of power etc. Helmut 2016-03-26 14:46
- Significant ≠ relevant Astea 2016-03-24 20:10
- Study conduct in groups felipeberlinski 2015-02-04 22:36
- Study conduct in groups Helmut 2015-02-04 12:57
- Study conduct in groups Smitha 2015-02-04 04:30
Ing. Helmut Schütz