Overall EMG-force relationships displayed a maximum 6% between-trial discrepancy and over 20% of maximal force, and mean ICC was above 0.79 within day and 0.27 0.61 between days across areas.
Overall EMG-force relationships displayed a maximum 6% between-trial discrepancy, with the rectilinear model being more similar between trials than curvilinear models across most of the contraction range (Fig. 4).
Overall fitted lines' between-trial discrepancies were evaluated.
In absolute numbers, mean force differences were below 6% for all sampling areas, with UPN having the largest between-trial discrepancies (within-day: AN ≤ 1%, UPN ≤ 3%, LPN ≤ 4%; between-day: AN ≤ 3%, UPN ≤ 6%, LPN ≤ 6%).
Although a certain degree of judgment was inevitable in categorising trials, discrepancies between independent assessors were small and easily resolved through discussion, with no material effect on the overall findings.
For seven trials, discrepancies between the planned sample size registered in http://ClinicalTrials.gov and the number of patients randomised based on the published reports were identified without any apparent explanation.
In conclusion, power to demonstrate a gain in OS limited in these trials; ultimately, if a significant OS improvement is observed in some but not at all trials, this discrepancy might be more attributable to chance than to a truly different drug impact on OS.
Conversely, if a significant OS improvement is observed in some but not at all trials, this discrepancy might be more attributable to chance than to a truly different drug efficacy.
Two independent reviewers extracted information from each trial, with discrepancies resolved by discussion with a third evaluator.
We will identify seven trial-specific discrepancy items, including the objectives, inclusion and exclusion criteria, end points, sample size, additional analyses, type of population analysis and sponsor acknowledgement.
111, 112 Several microbicide clinical trials based on the successful in vitro anti-HIV efficacy of the microbicide candidates, however, have failed to demonstrate in vivo efficacy, presenting (except the CAPRISA 004 trial) the discrepancies between the in vitro and in vivo data.
