Global CRO Body Urges Sponsors To Focus On Key Risk Factors As Coronavirus Threatens To Upend Clinical Trials
New guidance by the Association of Contract Research Organizations aims to ensure that data quality is unaffected, clinical trial sites are supported and patients are kept safe.
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New EU guidance on managing clinical trials in the context of COVID-19 requires sponsors to critically assess the feasibility of starting a new clinical trial or including new participants in an ongoing trial. A separate survey indicates that patient willingness to participate in new trials has dramatically declined due to the pandemic.
The UK’s Medicines and Healthcare products Regulatory Agency says that any increase in clinical trial protocol deviations in relation to coronavirus outbreak will not constitute a serious breach.
The EU will make it mandatory for clinical trial sponsors to prepare layperson summaries of their study results. Industry practices around content presentation, translation and dissemination of these documents will be keenly watched.