+ Reply to Thread
Results 1 to 5 of 5

Thread: sample size calculation non-inferiority trial

  1. #1
    Points: 3,239, Level: 35
    Level completed: 26%, Points required for next Level: 111

    Posts
    3
    Thanks
    3
    Thanked 0 Times in 0 Posts

    sample size calculation non-inferiority trial




    Dear Sir
    I need your help with a sample size calculation. We are planning to do a phase 3 non-inferiority randomised study comparing chemotherapy regimen A and B. We expect the 5 year overall survival with A to be 50% and B to be 40%. With a non-inferiority margin of 10%, power of 80% and p value 0.5, how many patients do we need to recruit in each arm. Sealed envelope gives infinite
    Regards
    Venkat

  2. #2
    Omega Contributor
    Points: 38,253, Level: 100
    Level completed: 0%, Points required for next Level: 0
    hlsmith's Avatar
    Location
    Not Ames, IA
    Posts
    6,989
    Thanks
    397
    Thanked 1,185 Times in 1,146 Posts

    Re: sample size calculation non-inferiority trial

    Do an internet search for:





    Non-Inferiority Tests for Two Survival Curves Using Cox’s Proportional Hazards Model

  3. The Following User Says Thank You to hlsmith For This Useful Post:

    venkat (10-17-2015)

  4. #3
    TS Contributor
    Points: 17,749, Level: 84
    Level completed: 80%, Points required for next Level: 101
    Karabiner's Avatar
    Location
    FC Schalke 04, Germany
    Posts
    2,540
    Thanks
    56
    Thanked 639 Times in 601 Posts

    Re: sample size calculation non-inferiority trial

    We are planning to do a phase 3 non-inferiority randomised study comparing chemotherapy regimen A and B.
    You are planning a trial with real patients? Where treatment is chemotherapy? And you rely on a webforum like this here, in order to determine how many human beings you will have to treat? No biostatistician involved in a chemotherapy trial with humans? That is surely surprising.

    And what sealed envelope are you referring to?

    With kind regards

    K.

  5. The Following User Says Thank You to Karabiner For This Useful Post:

    venkat (10-17-2015)

  6. #4
    Omega Contributor
    Points: 38,253, Level: 100
    Level completed: 0%, Points required for next Level: 0
    hlsmith's Avatar
    Location
    Not Ames, IA
    Posts
    6,989
    Thanks
    397
    Thanked 1,185 Times in 1,146 Posts

    Re: sample size calculation non-inferiority trial

    I was just hoping this was a hypothetical, say homework - but agreed on the dubious nature.


    The envelope contains infinite...love!

  7. The Following User Says Thank You to hlsmith For This Useful Post:

    venkat (10-17-2015)

  8. #5
    Points: 3,239, Level: 35
    Level completed: 26%, Points required for next Level: 111

    Posts
    3
    Thanks
    3
    Thanked 0 Times in 0 Posts

    Re: sample size calculation non-inferiority trial


    Dear all
    Thank you for your valuable comments. I am clinician and not a statistician. Yes this is a chemotherapy trial involving real patients. The trial is currently an idea and needs ethics review and approval. I need to know whether it is practical to do the trial at my hospital. If I have to randomise 1000 patients it is not feasibleas I will not be able to recruit these many patients in 5 years, but if it involves 100-150 patients then it can be done. I have got differing opinions from 2 bio-statisticians, one says we need a sample size of about 150 and the other says 900 and both of them are confident of their calculations.
    The link for sealed envelope (online sample size calculator is given below)
    https://www.sealedenvelope.com/power...y-noninferior/

+ Reply to Thread

           




Posting Permissions

  • You may not post new threads
  • You may not post replies
  • You may not post attachments
  • You may not edit your posts






Advertise on Talk Stats