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Cancer Trial Reporting
As the clinical trial industry moves toward decentralisation, a new report by US Medical journal, JAMA oncology, has given an interesting insight into how remote monitoring works for Cancer Clinical Trials by analysing the effects of the COVID-19 pandemic on trial reporting.
Among its findings, the study observed that increased remote monitoring: Increases flexibility in trial participation and communication with physicians and may well be safe for patients going forward. However, it also may have implications for observing toxic effects from treatment, and this needs to be further examined.
A decline in Serious Adverse Event (e.g. serious deterioration of health or death) reporting was observed, likely due, not to telehealth, but other factors such as staffing shortages, heavy administration loads and frequent protocol changes.
It was felt that further studies were warranted to more closely observe if a link exists between remote participation and the level of SAE reporting.