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Comparator: studies comparing chest X-ray with chest ultrasound.
There were five fibrinogen concentrate comparator studies, two comparing fibrinogen concentrate with no fibrinogen concentrate or with a non blood product and, importantly, three studies comparing the effect of fibrinogen concentrate directly with FFP (administered in combination with other allogeneic products).
Drug resource use was calculated using data from non-comparable studies due to the lack of comparator studies.
Of the FFP comparator studies analysed, only 38%2020 of 52) compared FFP with no FFP or with a non blood product (for example, colloid or crystalloid).
There are few good comparator studies for second-line therapy, but a randomized phase III study comparing a regimen of oxaliplatin, folinic acid, and fluorouracil to best supportive care (BSC) in patients who received first-line gemcitabine demonstrated a median survival time of 4.8 months for the active arm, compared to 2.3 months for the BSC arm 16.
In the 30 active comparator studies, composite approach detected larger differences in effect size than LOCF (ES=.05) and MMRM (ES=.076).
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Pooled data from double-blind active-comparator studies comparing repaglinide with SU have shown that the risks of severe hypoglycaemia (defined as symptomatic hypoglycaemia requiring help from another person plus blood glucose < 2.5 mmol/l) were 1.3% and 3.3%, respectively.
The following data were extracted and checked independently by two reviewers: database indexed, publication year, index test, study type, sample size, target disease, comparator, study subjects, outcome (i.e., sensitivity and specificity), conclusions, and funding source.
Based on that indirect comparisons are generally accepted within the German early benefit assessment, the challenge for the future will be to bring together: the determination of the appropriate comparator by G-BA and the selection of the appropriate comparator, study choice and selection of patient subgroups by the manufacturer to give indirect comparisons a higher relevance in Germany.
The key weakness was selection of a single comparator study.
The comparator study did not report this outcome [ 20].
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