Sample size calculation and writing the stat. chapter for the protocol
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- Proposals: 3
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- #183602
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Description
Experience Level: Intermediate
THIS IS NOT STUDENT WORK, IT IS REQUIRED FOR REAL CLINICAL TRIAL SPONSORED BY PHARMACEUTICAL MANUFACTURER
study proposals:
Option 1
Study population:
DM2 patients failed on combination A+B. HbA1c as inclusion criteria - 7.6 – 10 % (anticipated baseline HbA1c - 8.3±0.7 %).
Product C is added for 24 wks.
The primary objective – demonstrate the benefit of therapy escalation to triple regimen (A+B+C). The clinically significant benefit– let’s say 0.5% HbA1c reduction compared to baseline.
Option 2
The same patient population.
Two groups:
1. triple regimen with add on Product C as in Option 1
2. switch from B to C
The primary objective – demonstrate non-inferiority of switch (A+C) vs. triple regimen (A+B+C) after 24 wks.
I need pt. number for group ratio 1x1 and 1x2.
Please confirm that you are interested and capable and give you price and timeline
Thank you
study proposals:
Option 1
Study population:
DM2 patients failed on combination A+B. HbA1c as inclusion criteria - 7.6 – 10 % (anticipated baseline HbA1c - 8.3±0.7 %).
Product C is added for 24 wks.
The primary objective – demonstrate the benefit of therapy escalation to triple regimen (A+B+C). The clinically significant benefit– let’s say 0.5% HbA1c reduction compared to baseline.
Option 2
The same patient population.
Two groups:
1. triple regimen with add on Product C as in Option 1
2. switch from B to C
The primary objective – demonstrate non-inferiority of switch (A+C) vs. triple regimen (A+B+C) after 24 wks.
I need pt. number for group ratio 1x1 and 1x2.
Please confirm that you are interested and capable and give you price and timeline
Thank you
Alex A.
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Last project
7 Mar 2012
Russian Federation
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