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The regulatory background and logistical processes underlying trial registration in ClinicalTrials.gov have been previously described in detail.
Computational systems biology can directly model the biological mechanisms underlying trial interventions and inform the probabilistic assessment of trial outcomes.
They concluded that, given the extent of disparity between the assumptions underlying trial design and the assumptions held by the lay public, the solution is unlikely to be simple.
Objective To investigate whether published results of industry funded trials of recombinant human bone morphogenetic protein 2 (rhBMP-2) in spinal fusion match underlying trial data by comparing three different data sources: individual participant data, internal industry reports, and publicly available journal publications and conference abstracts.
Doing so also requires access to the underlying trial data, but these are not commonly reported.
Responsible restorative authorship requires those publishing articles to also make the underlying trial data available simultaneously as an electronic appendix.
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Since the underlying trials had different visit intervals, we interpolated, if needed, HAQ scores of each patient for weeks 0, 4, 8, 12, 16, 20, and 24.
It is currently focused on modeling the biological mechanisms underlying a trial though trials are typically motivated and supported primarily by observational data and previous trial results.
Results suggest a large mismatch between the assumptions underlying the trial design, and the assumptions that lay participants can bring to bear when they try to make sense of descriptive information about randomisation and equipoise.
For many patients, the condition underlying their trial consultation was not their only health problem.
We simulated the underlying true trial intervention effects, as log odds ratio ln(OR i )~ N OR, τ ), where OR is the true intervention effect expressed as an odds ratio.
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CEO of Professional Science Editing for Scientists @ prosciediting.com