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Elizabeth C. James
Statistics for Life Sciences, Medicine, Health Sciences
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Article
Open AccessOverlap between adverse events (AEs) and serious adverse events (SAEs): a case study of a phase III cancer clinical trial
Safety data is required to be collected in all clinical trials and can be separated into two types of data, adverse events and serious adverse events. Often, these types of safety data are collected as two dis...
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Article
Open AccessEarly warnings and repayment plans: novel trial management methods for monitoring and managing data return rates in a multi-centre phase III randomised controlled trial with paper Case Report Forms
Monitoring and managing data returns in multi-centre randomised controlled trials is an important aspect of trial management. Maintaining consistently high data return rates has various benefits for trials, in...
