Clinical Gene Transfer: Adverse Event Reporting Fully Harmonized

Adverse event reporting in clinical trials: room for improvement.

Regulatory and ethical guidelines require clinical trial sponsors to disseminate clinical trial adverse event reports to involved investigators and human research ethics committees. Compliance with these guidelines has resulted in a major administrative burden for ethics committees. This burden does not necessarily contribute to the protection of clinical trial participants. Rationalisation of ...

Standardizing adverse drug event reporting data

BACKGROUND The Adverse Event Reporting System (AERS) is an FDA database providing rich information on voluntary reports of adverse drug events (ADEs). Normalizing data in the AERS would improve the mining capacity of the AERS for drug safety signal detection and promote semantic interoperability between the AERS and other data sources. In this study, we normalize the AERS and build a publicly a...

Adverse event reporting systems and safer healthcare.

At the heart of improvement and safety in healthcare is the now-familiar tenet that was espoused decades ago by Demming and paraphrased by Berwick. Need we repeat it again? Every defect should lead to improvement processes that make care safer. It is time to deliver on the promise of reporting systems in patient safety. While it is clear that event-reporting systems are now central elements in ...

The Vaccine Adverse Event Reporting System (VAERS).

Immunizations against most vaccine-preventable diseases will be needed indefinitely unless the disease is eradicated. Public acceptance of immunizations may be threatened as vaccine coverage increases and disease decreases, however, due to the increase in both causally and coincidentally related vaccine adverse events. The post-marketing surveillance for such events in the USA in response to th...

Towards an Adverse Event Reporting Ontology