Optimal approaches to data collection and analysis of potential immune mediated disorders in clinical trials of new vaccines (original) (raw)

The Brighton Collaboration: Creating a global standard for case definitions (and guidelines) for adverse events following immunization

AHRQ: Advances in …, 2005

To advance the science of immunization safety and "vaccinovigilance," a globally acceptable, common vocabulary for adverse events following immunization (AEFIs) is needed to promote comparability of data. Methods: The Brighton Collaboration develops standardized case definitions and guidelines for data collection, analysis, and presentation via participation of more than 500 experts from 57 countries from public health, clinical care, academia, regulatory organizations, and industry. Results: The first six Brighton case definitions and guidelines have been finalized. Work continues on 17 additional topics. Formal evaluation studies of definitions are underway. More than 67 investigators in 30 countries have begun or are considering implementation of the definitions and guidelines. Conclusions: Standardized and globally implemented case definitions and guidelines for AEFIs will enhance comparability of vaccine safety data and ultimately maintain trust in immunization programs worldwide. The Brighton Collaboration may be a useful model for other realms of patient safety.

Evaluation of adverse effects of vaccines: the case-control approach

Vaccine, 2002

When the hypothesis of a link between vaccination and a possible adverse outcome arises, further investigation is required to confirm or refute the suspicion. Given the rarity of most serious adverse effects, a case-control approach will often be chosen. This paper discusses aspects of the design, analysis and interpretation of case-control studies to evaluate vaccine adverse effects. Potential biases (and how to minimise such biases) in the selection of cases and assessment of vaccine exposure and the potential for confounding are discussed. Finally the increasing use of electronic databases in the evaluation of vaccine adverse effects is considered.

Monitoring signals for vaccine safety: the assessment of individual adverse event reports by an expert advisory committee. Advisory Committee on Causality Assessment

Bulletin of the World Health Organization, 2000

Monitoring vaccine safety is a complex and shared responsibility. It can be carried out in many ways, one of which is the reporting of individual cases of adverse reactions thought to be due to vaccination. The task is difficult because ascribing causality to an individual case report is fraught with challenges. A standardized evaluation instrument--known as the causality assessment form--was therefore developed for use by an expert advisory committee to facilitate the process. By following the several sections in this form, the members of the committee are taken through a series of points to establish causality. These points include the basic criteria for causation such as biological plausibility, the time elapsed between the vaccine administration and the onset of the adverse event, and whether other factors (drugs, chemicals or underlying disease) could account for the adverse symptoms. The form concludes with a consensus assessment of causality, a commentary about the assessment...