Evaluation of the safety of intravesical BCG therapy in France: analysis of serious adverse events notified over a three-year period

Objectives: Intravesical BCG therapy remains the first-line prophylactic treatment for recurrences of superficial bladder tumours. However necessary the safety, of this medicinal product, for which a potential risk of complications was demonstrated during development, needs to be evaluated

The Brighton Collaboration: addressing the need for standardized case definitions of adverse events following immunization (AEFI)

To further scientific progress of immunization safety, comparability of data from clinical trials and surveillance systems is essential. Comparability requires the availability of standardized case definitions for adverse events following immunization (AEFI) and guidelines for case determination, recording and data presentation. Method: International collaborative working groups, consisting of professional volunteers from developed and developing countries, conduct systematic literature reviews to develop 50-100 AEFI definitions. Case definitions are finalized after a comment period by a reference group consisting of organizations concerned with immunization safety, and will be disseminated via the world-wide-web and other means for free world-wide use. Results: Literature reviews yielded substantial diversity in data collection and presentation. We have developed standardized case definitions together with guidelines for use in clinical trials and surveillance systems. Conclusions: Diversity in safety methods leads to considerable loss of scientific information. We have built the necessary international network of currently about 300 participants from patient care, public health, scientific, pharmaceutical, regulatory and professional organizations to develop and assess standardized AEFI case definitions and guidelines. Evaluation studies, global implementation, ongoing definition development and a continuously growing network will be essential for the success of the collaboration. Published by Elsevier Science Ltd