h******e
发帖数: 1791 | | r*****o
发帖数: 140 | 2 我的理解是可能一样大，但是有时候safety可能会更大一点。
关键是看protocol。
因为有可能受试者在随机化后虽然给过药，但是没有任何疗效评价,protocol认为需要
剔出FAS（即ITT）；或者受试者严重违背入组标准，按照protocol的要求不进入FAS分
析；或者发现某个重要的计算主要疗效指标的基线数据缺失，无法算疗效。
但只要以上情况的受试者被给了药，仍然可以进入Safety分析。 | m****r
发帖数: 202 | 3 A safety population
is a group of patients who have taken the drug at least once.
An ITT population
was defined as those individuals who had applied their assigned treatment at
least once and had returned for assessment of the primary end point (such
as healing of the fissure). Patients who failed to present for assessment
and who would not reattend for assessment to determine an outcome were
deemed to have withdrawn their consent to participate and were excluded from
the analysis.
In our work, patients who were randomized were considered as ITT. There is a
variable called randomized with value of ‘yes’ or ‘no’. | d***2
发帖数: 341 | 4 This is usually called MITT (Modified ITT), the true ITT is the population
of subjects who are randomized or enrolled (if not randomized trials) to
receive study treatments.
To answer LZ's question on population size:
ITT >= Safety >= MITT >= Per Protocol (this depends on the definitions of
major protocol violations)
Of course, there could be odd cases that change this order, for example, you could get a non-randomized subject who receives study medication. Don't ask me how, it happens.....
at
from
【在 m****r 的大作中提到】
: A safety population
: is a group of patients who have taken the drug at least once.
: An ITT population
: was defined as those individuals who had applied their assigned treatment at
: least once and had returned for assessment of the primary end point (such
: as healing of the fissure). Patients who failed to present for assessment
: and who would not reattend for assessment to determine an outcome were
: deemed to have withdrawn their consent to participate and were excluded from
: the analysis.
: In our work, patients who were randomized were considered as ITT. There is a
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