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The final trial reported a lower incidence of nocturnal hypoglycemia with premixed biphasic insulin lispro 25/75 despite a lower incidence of symptomatic hypoglycemia with insulin glargine (Malone et al. 2005).
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First, relying on the published or final trial report may not result in accurate assessment of selective outcome reporting.
This would involve appraisal of the trial protocol and its amendments, observation of the trial conduct and appraisal of the final trial report.
Furthermore, improved protocol content would help facilitate the critical appraisal of final trial reports and results.
The final trial report will link the full protocol, protocol amendments, consent form, final statistical analysis plan and laboratory methods.
6 7 8 174 These substantive modifications are rarely acknowledged in the final trial reports, providing an inaccurate impression of trial integrity.
Substantive contributions to the design, conduct, interpretation and reporting of a clinical trial are recognised through the granting of authorship on the final trial report.
267 Substantive contributions to the design, conduct, interpretation, and reporting of a clinical trial are recognised through the granting of authorship on the final trial report.
Authors of the final trial report will have made substantial contribution to the design, conduction, interpretation and reporting of the trial.
The patient population accrued to the MA.14 trial was well defined, and details are given in the final trial report [ 15].
We recommend that the details of and justification for the allocation process being employed are documented and given in the final trial reports.
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Justyna Jupowicz-Kozak
CEO of Professional Science Editing for Scientists @ prosciediting.com