Whatever the outcome of the interim analysis, all randomised patients will be followed until 36 months after randomisation of the last patient.
In assessing the impact of this kind of initiative, the authors argue that attention should be paid to understanding the role of interim outcomes as a marker of research influence in a complex environment.
Methodologically, this is somewhat unusual in that current practice is that interim analyses are carried out by a committee who are not investigators in the study [ 11]; indeed, it is uncommon for investigators to even be aware of interim outcome data by study group.
In CAPRICORN, the introduction of a composite co-primary outcome subsequent to review of interim data can be seen as an attempt to achieve a positive trial by using a composite endpoint which would have a higher likelihood of accruing events.
Halfway through the research, the first author described the main outcomes of the analysis in an interim report.
(Three articles described the same cohort study with two interim [ 17, 18] and one final report [ 19], one study reported the outcomes for the same cohort in two articles [ 10, 29] and two articles report the outcomes of one cohort with one interim [ 31] and one final report [ 28]).
The sensitivity and specificity of interim PET/CT in predicting the outcome of DLBCL patients treated with R-CHOP chemotherapy were not satisfactory (52.4% and 67.8%, resp .. To improve this, some more work should be done to unify the response criteria and some more research to assess the prognostic value of interim PET/CT with semiquantitative analysis.
A positive outcome at interim analysis could also trigger the start of a second phase III study.
Subsidiary analyses will report results of tests for secondary outcome measures and primary outcome measures at interim occasions.
Whereas overall mortality until 3 years of age was the primary outcome in the planned trial, the incidence of measles, admissions to hospital for measles, and measles mortality were the primary outcomes in the interim analysis.
We investigated the ability of interim positron emission tomography (PET) regarding early prediction of pathology outcomes.
