Revised EU Guide Addresses Ambiguities In Reporting of Safety Info From Trials
The pharmaceutical industry is hoping that changes to the EU guideline on the management and presentation of reference safety information (RSI) in clinical trial applications will help companies struggling with new regulatory focus on this complex subject.
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A UK good clinical practice inspector discusses common findings issued in relation to clinical trials as well as the challenges posed by new technologies, such as use of apps on smartphones and electronic patient diaries to record outcomes.
An EU guideline on the complex subject of how drug sponsors should present and manage the reference safety information in their clinical trial applications is nearing finalization. For the past several months, drug companies have been grappling with an increased regulatory focus on RSI, which has resulted in their trial applications being rejected or studies being significantly delayed.
The UK regulatory agency, the MHRA, has identified a range of problems in the way that companies manage clinical trial reference safety information, although views as to what needs to be done to address these issues differ between the regulators and the regulated.