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Note that tumour volume at the time of efficacy assessment is, however, larger than tumour volume at the time of diagnosis, Vd.
Since the ideal period for determining whether a response to treatment has occurred remains controversial [ 62] and varied considerably across the selected studies, we examined how efficacy varied by length of follow-up or time of efficacy assessment.
If the drug can partially control tumour growth, the tumour volume at the time of efficacy assessment will be larger than Vi (closer to Vn) and the treatment efficacy will be less than e2 in Figure 1.
The left side of the above equation is the overall effect of treatment during time from treatment initiation to time of efficacy assessment, and can be denoted as TR.
Tumour response was measured by the logarithm of the ratio of post-treatment tumour volume to the volume of tumour (at the time of efficacy assessment) if therapy was not initiated.
The right side of the above equation can be replaced using Equation (2), which gives: where Vi is tumour volume at the time of therapy initiation, and Vt and Vn are the volume of treated and corresponding (hypothetical) non-treated tumour at the time of efficacy assessment, respectively.
Similar(49)
CGRP RO was evaluated in healthy subjects (n=3) at the lowest clinically efficacious dose (140 mg, PO) of telcagepant ~2h after dosing, coinciding with the time point of efficacy evaluation in clinical migraine studies.
20, 21 Vaccines also require close study of the cost and time course of efficacy.
The use of other systemic antifungal agents and rifampin was prohibited until the time of the efficacy evaluation.
At the time of balancing efficacy (symptomatic venous thromboembolism) and safety (major bleed and deaths), the different anticoagulants did not differ significantly.
This criterion was recoded at the time of the efficacy analysis into a 2-point scale (overall responses (OR=1), comprising complete response (CR) plus partial response (PR) vs stable disease (SD) plus progressive disease=0).
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Justyna Jupowicz-Kozak
CEO of Professional Science Editing for Scientists @ prosciediting.com