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Standard safety monitoring of trials (despite all its limitations) and crude reporting of events might be sufficient for clinical decision making in circumstances where the spectrum of harms is reasonably well known and clinically measurable.
[ 7] Visible multiplicities, such as occur with pre-specified subgroup analyses or sequential monitoring of trials are difficult enough, but at least in these circumstances the researchers (and users of the research) know how many multiple comparisons were under consideration.
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All authors participated in study implementation and provided monitoring of trial conduct.
JD, WL, and GB participated in study implementation, and provided monitoring of trial conduct.
The Trial Manager, or where required, a nominated designee of the Sponsor, shall carry out monitoring of trial data as an ongoing activity.
Each participating country will have a study monitor who will be responsible for overview and monitoring of trial activities at each study site within each country, including maintenance of the trial master file, site pharmacy files and site investigator file.
This observation highlights the need for rigorous monitoring of trial evidence, as research output (at least in the form of randomised trials) cannot be reliably predicted from burden of disease or relative burden in high and low income regions.
The logistical problems relate to the rapid identification of the extra resources required to allow continued excellence in day-to-day management and monitoring of trial governance (both in participating centres and in coordinating trials units).
Monitoring of trial data shall include confirmation of informed consent; source data verification; data storage and data transfer procedures; local quality control checks and procedures, back-up and disaster recovery of any local databases and validation of data manipulation.
Although these results must be confirmed by further studies, they again suggest that rigorous monitoring of trial evidence is necessary, as regional differences in the suitability of trials to local health needs may lead to greater future regional inequity in population health.
Monitoring in eight trials (12.7%) and data management in seven trials (11.1%) were conducted by pharmaceutical companies, and monitoring of seven trials (11.1%) and data management of nine trials (14.3%) were conducted by a contract research organization (CRO).
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CEO of Professional Science Editing for Scientists @ prosciediting.com