raghavendra_s
★    

2010-02-18 07:20
(5964 d 03:46 ago)

Posting: # 4783
Views: 4,874
 

 Phase II study [Power / Sample Size]

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Dear Sir,

Please clarify my queries related to designing a Phase II clinical study;
-Is there any suggested sample size for Phase II studies?
-Is it mandatory to have control group/comparator for Phase II clinical studies?

Thanks in Advance.

Kind regards,
 
ElMaestro
★★★

Denmark,
2010-02-18 14:08
(5963 d 20:58 ago)

@ raghavendra_s
Posting: # 4788
Views: 4,000
 

 Phase II study

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Hi ragvendra,

your question is a little vague to me.
Which question is the phase II trial intended to answer? Please provide as much info as possible of the context.

Best regards
EM.
 
ioanam
★    

Romania,
2010-02-18 22:23
(5963 d 12:43 ago)

@ raghavendra_s
Posting: # 4793
Views: 3,965
 

 Phase II study

Post reply
Dear Sir,
for Phase II clinical trials you have the following references:
ICH E9 - Statistical Principles for Clinical Trials (for evaluation of sample size)
and
ICH E10 - Choice of Control Group and Related Issues in Clinical Trials.

Good luck, Jo
 
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