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AIM: To compare and contrast interventional radiology (IR) clinical and research practices with the technology assessment and evidence-based medicine (EBM) paradigms and make suggestions for the phased evaluation of new IR procedures.
The stepped wedge design is suitable for a phased evaluation approach, where the intervention is likely to do more good than harm, thus making it unethical to completely withhold the intervention from a control group, and/or where it is not possible to start delivery of the intervention to all participants at the same time [ 21].
Several phased evaluation schemes for diagnostic tests have been proposed in the literature.
Experimental testing, however, is time and cost prohibitive for design-phase evaluation of tens or hundreds of design variations.
As UrgIndex filters were completed with the 158 medical records described above, a new, random selection of infected patients was made in the retrospective cohort for test phase evaluation.
Among the eight evaluable patients treated at dose level 4 (the recommended dose for phase II evaluation), median TTP was 3.5 months (range 1.4 10.2 months).
The historical-control methodology offers a novel, meaningful approach for phase 3 evaluation of orphan diseases associated with high mortality.
As such, the primary endpoint for phase II evaluation has been tumor response rate, the percentage of patients whose tumors shrink > 50%.
The reference WHO method for phase 3 evaluation of ITNs efficacy is based on the measurement of P. falciparum density in human populations [12].
The 3-weekly dosing schedule was chosen for phase II evaluation.
The dose level below the MTD was recommended for phase II evaluation.
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