No of Vonteers requirment [Power / Sample Size]
Dear All
A very good morning
There is a question related to sample size which has always haunted me and I would be happy if anyone can please answer me that with proper explanation
Que: Which study (For EMEA or FDA) will need higher number of volunteer assuming drug is highly variable. (ISCV>30%)
I always say it would be FDA as one have to meet the 95% Upper confidence interval but was always unable to explain that in detail.
Was I right when I said number of volunteers required will be higher in EMEA?
What will be the scenario in cases where ISCV is >50% (lets say 60%)?
Study meant for EMEA will need higher number of volunteers as the CI limits would be fixed.
Please correct me if I got it all wrong
Thanks in advance for your help/suggestion
Regards
Srinetram
A very good morning
There is a question related to sample size which has always haunted me and I would be happy if anyone can please answer me that with proper explanation
Que: Which study (For EMEA or FDA) will need higher number of volunteer assuming drug is highly variable. (ISCV>30%)
I always say it would be FDA as one have to meet the 95% Upper confidence interval but was always unable to explain that in detail.
Was I right when I said number of volunteers required will be higher in EMEA?
What will be the scenario in cases where ISCV is >50% (lets say 60%)?
Study meant for EMEA will need higher number of volunteers as the CI limits would be fixed.
Please correct me if I got it all wrong
Thanks in advance for your help/suggestion
Regards
Srinetram
Complete thread:
- No of Vonteers requirmentSrinetram 2015-01-08 06:41 [Power / Sample Size]
- No of Vonteers requirment Dr_Dan 2015-01-08 09:31
- Sample size for scABE d_labes 2015-01-08 10:04
- FDA (RSABE) vs. EMA (ABEL) Helmut 2015-01-08 13:57