w******8
发帖数: 59 | 1 I am so confused about what to include in the ITT population:
1) Some patients were randomized and got baseline measurements but never got
treatment and then dropped out. I don't think they need to be included
because their dropping out have nothing to do with the treatment.
2) Some patients drop out specifically for reasons not related to treatment.
For example, a patient dropped out because he found out he has another
disease and would like to focus on treatment of that disease. And this
patient had no measurement other than that for the baseline.
Could someone help me?
Thanks! |
h******e
发帖数: 1791 | 2 ITT和randomization密切相关，只要被randomized，就要包括在ITT里。 |
d***2
发帖数: 341 | 3 ITT means the subject is to receive study treatment, therefore any
randomized subject is included in the ITT population.
There are times companies use Modified ITT (MITT) for efficacy analyses,
this population includes subjects who have data for the efficacy
analyses (
ex..have both baseline and post-baseline data).
ITT has nothing to do with drop-outs, nor the reason of drop-outs.
Subjects mentioned in your (1) and (2) would be excluded from the safety
population since they never received study treatment.
never
got
included
treatment.
another
【在 w******8 的大作中提到】
: I am so confused about what to include in the ITT population:
: 1) Some patients were randomized and got baseline measurements but never got
: treatment and then dropped out. I don't think they need to be included
: because their dropping out have nothing to do with the treatment.
: 2) Some patients drop out specifically for reasons not related to treatment.
: For example, a patient dropped out because he found out he has another
: disease and would like to focus on treatment of that disease. And this
: patient had no measurement other than that for the baseline.
: Could someone help me?
: Thanks!
|
x*****r
发帖数: 2404 | 4 my 2 cents.
not necessary to be randomized, depends on your definition for ITT, consider
some trials might not even be a randomized trial.
focus on INTENT to treat, so not necessary actually treated. |
w******8
发帖数: 59 | 5 I am so glad to find this from ICH E9:
In some situations, it may be reasonable to eliminate from the set of all
randomised subjects any subject who took no trial medication. The intention-
to-treat principle would be preserved despite the exclusion of these
patients provided, for example, that the decision of whether or not to begin
treatment could not be influenced by knowledge of the assigned treatment.
In other situations it may be necessary to eliminate from the set of all
randomised subjects any subject without data post randomisation. No analysis
is complete unless the potential biases arising from these specific
exclusions, or any others, are addressed.
http://www.emea.europa.eu/docs/en_GB/document_library/Scientifi |
i******n
发帖数: 839 | 6 ITT应该是所有接受treatment的subjects，这和safety population是一样的，不同的
是treatment group的划分，ITT是按random code来的，是计划给这个subject的
treatment，用在efficacy analysis；safety population是按subject实际接受的
treatment来的。
比如，一个subject,按random code应该吃studydrug，但是clinical site给错了，给
了placebo,按ITT这个病人就是在study drug group作efficacy analysis；作safety
analysis，按实际的treatment算，这个病人就是在placebo group。
没有吃到药的肯定不在ITT里面。 |
x*****r
发帖数: 2404 | 7 not necessary, depends on your definition.
【在 i******n 的大作中提到】
: ITT应该是所有接受treatment的subjects，这和safety population是一样的，不同的
: 是treatment group的划分，ITT是按random code来的，是计划给这个subject的
: treatment，用在efficacy analysis；safety population是按subject实际接受的
: treatment来的。
: 比如，一个subject,按random code应该吃studydrug，但是clinical site给错了，给
: 了placebo,按ITT这个病人就是在study drug group作efficacy analysis；作safety
: analysis，按实际的treatment算，这个病人就是在placebo group。
: 没有吃到药的肯定不在ITT里面。
|
