Main outcome measures Trial discontinuation before completion and non-publication after completion.
The binary outcome targets were firstly discontinuation (versus completion) and secondly non-publication (versus publication); we used primary publication (in a peer reviewed journal) for this modelling process.
For this study, we defined wastage of resources in three domains, which we subsequently used as the main outcome measures: discontinuation (versus completion); non-publication (versus publication); and feasibility of contacting trial investigators for both discontinued and unpublished studies.
We review medical charts to obtain results for HCV viral load tests performed at 4 weeks (rapid viral response), 12 weeks (early viral response), 24 weeks and/or 48 weeks (end of treatment response), and 24 weeks after treatment discontinuation or completion (sustained viral response).
Discontinuation before planned completion of the study implies insufficient efficacy or unacceptable adverse effects.
The results show that a variety of demographic and apprenticeship variables are related to completion, discontinuation, or long-term continuation in programs.
For this post hoc analysis, patients who received PP continuously from study entry through discontinuation or study completion were included.
After paclitaxel discontinuation at the completion of six cycles, everolimus could be maintained weekly until tumour progression.
The reasons for treatment discontinuation were: treatment completion (per-protocol duration of treatment: 9 months) in 8 cases (29.6%), non-manageable toxicity in 7 cases (25.9%), documented tumor progression in 7 cases (25.9%), clinical tumor progression without radiological documentation in 2 cases (7.4%) and patient or investigator decision in 3 cases (11.1%).
The conditional probabilities were estimated by pooled (repeated) logistic regressions with an indicator for patient presence/absence in the study at every time interval following evaluation visit (up to discontinuation or study completion) as a dependent variable and current dose, severity of AE, and efficacy scores during current and previous visit intervals as independent variables.
Only patients who received PP continuously from study entry through discontinuation or study completion in the DB and OLE phases were included in data analyses using intent-to-treat (ITT) analysis set, which included patients who received at least 1 dose of PP during the study.
