Allowed Time gap between Cohorts in a BE study [Design Issues]
Hi Achievwin,
I agree with Helmut. There is no real limit in my experience.
From a stats point of view it isn't an issue at all. Of course there are a few situations when you wish to avoid seasonal variations between cohorts (rhinitis or asthma patients etc), but you probably have volunteers?
Re. your sentence "Needless to say the Bioanalysis and PK work will be carried out after completion of all cohorts.": I think it is better in practice to analyse samples after each cohort and accumulate the PK-data until the time of stats analysis.
❝ Are there any limitations on the maximum days allowed between different cohorts (let us say Cohort 1 and Cohort 2) in a Cross over BE study? Needless to say the Bioanalysis and PK work will be carried out after completion of all cohorts.
I agree with Helmut. There is no real limit in my experience.
From a stats point of view it isn't an issue at all. Of course there are a few situations when you wish to avoid seasonal variations between cohorts (rhinitis or asthma patients etc), but you probably have volunteers?
Re. your sentence "Needless to say the Bioanalysis and PK work will be carried out after completion of all cohorts.": I think it is better in practice to analyse samples after each cohort and accumulate the PK-data until the time of stats analysis.
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Pass or fail!
ElMaestro
Pass or fail!
ElMaestro
Complete thread:
- Allowed Time gap between Cohorts in a BE study Achievwin 2017-10-26 16:12 [Design Issues]
- Allowed Time gap between Cohorts in a BE study Helmut 2017-10-26 19:08
- Allowed Time gap between Cohorts in a BE studyElMaestro 2017-10-26 23:01