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Issues in Selection of Deltas in Non-Inferiority Trials  : Acute Bacterial  Meningitis and Hospital-Acquired Pneumonia dr shabeel pn www.hi-dentfinishingschool.blogspot.com
Introduction ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Clinical Trials ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Non-Inferiority Trials ,[object Object],[object Object],[object Object],[object Object],[object Object]
Non-Inferiority Margins ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],-20% +20% -8% -15%
Components of Delta ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Components of Delta -  Delta 1 ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Components of Delta -  Delta 2 ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Components of Delta -  various diseases ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Components of Delta Meningitis and HAP ,[object Object],[object Object],[object Object],[object Object]
Components of Delta Meningitis and HAP ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Historical Data - Meningitis ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Historical Data - Meningitis ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Historical Data - HAP ,[object Object],[object Object],[object Object],[object Object],[object Object]
[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],Historical Data - HAP
Historical Data - HAP ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Components of Delta Meningitis ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Components of Delta HAP ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Components of Delta Meningitis and HAP ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Consequences of Failure ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Practical Issues ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Clinical Trial Implications: Sample size per arm to achieve 80% power 
Epidemiology of Meningitis* *Based on 248 cases in 1995 from Schuchat et al. N Engl J Med. 1997;337:970-6.
Epidemiology of Meningitis ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Epidemiology of HAP ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Epidemiology ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Recent Trials ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Clinical Trial Implications: Sample size per arm to achieve 80% power 
Components of Delta Meningitis and HAP ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
The Balance ,[object Object],[object Object],[object Object]

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meningitis

  • 1. Issues in Selection of Deltas in Non-Inferiority Trials : Acute Bacterial Meningitis and Hospital-Acquired Pneumonia dr shabeel pn www.hi-dentfinishingschool.blogspot.com
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  • 22. Clinical Trial Implications: Sample size per arm to achieve 80% power 
  • 23. Epidemiology of Meningitis* *Based on 248 cases in 1995 from Schuchat et al. N Engl J Med. 1997;337:970-6.
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  • 28. Clinical Trial Implications: Sample size per arm to achieve 80% power 
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Notas do Editor

  1. Obviously the choice of delta has a big impact on sample size required to provide robust evidence of efficacy. Let’s consider some examples. On the x-axis, we have assumed success rates FOR BOTH ARMS On the y-axis we have the sample size necessary to provide the burden of proof that a desired level of similarity is met with high confidence So when the underlying success rate if 80% for both AC and new -- we would need about 100 pts per arm with a delta of 15, 250 per arm for a delta of 10 and 1000 per arm for a delta of 10% Note that sample size requirements go down as the success rate approaches 100% and increase as the success rate approaches 50%.
  2. Obviously the choice of delta has a big impact on sample size required to provide robust evidence of efficacy. Let’s consider some examples. On the x-axis, we have assumed success rates FOR BOTH ARMS On the y-axis we have the sample size necessary to provide the burden of proof that a desired level of similarity is met with high confidence So when the underlying success rate if 80% for both AC and new -- we would need about 100 pts per arm with a delta of 15, 250 per arm for a delta of 10 and 1000 per arm for a delta of 10% Note that sample size requirements go down as the success rate approaches 100% and increase as the success rate approaches 50%.