2004D-0189 - Draft Guidance for Industry on Premarketing Risk Assessment; Development and Use of Risk Minimization Action Plans; and Good Pharmacovigilance Practices and Pharmacoepidemiologic Assessment; Availability
FDA Comment Number : EC1
Submitter : Dr. Katrin Kohl Date & Time: 07/14/2004 06:07:53
Organization : The Brighton Collaboration
Category : International Organization
Issue Areas/Comments
GENERAL
GENERAL
The Brighton Collaboration, formed in 2000, is an international voluntary collaboration to facilitate the development, evaluation, and dissemination of high quality information about the safety of human vaccines by enabling comparability of data through the development of harmonized (or standardized) case definitions on adverse events following immunization. It is currently funded by the U.S. Centers for Disease Control and Prevention and the World Health Organization.
As of April 2004, the Collaboration included >500 scientists volunteering from industry, regulatory agencies, public health, clinical care and academic organizations coming from 57 countries. Six harmonized case definitions and guideline documents regarding ?adverse events following immunization? (AEFI) have been published in January 20041-6 and 18 additional definitions and corresponding guidelines are at various stages of development. It plans to develop approximately harmonized case definitions of about 100 AEFI together with their respective guidelines.

The comments submitted in this document have been written by representatives of the Steering Committee (with the reclusion of Miles Braun from FDA from this submission) and the Secretariat of the Brighton Collaboration.
The Brighton Collaboration Steering Committee and Secretariat welcome the opportunity to comment on the draft guidance for Industry Good Pharmacovigilance Practices and Pharmacoepidemiologic Assessment, and support the guidance put forth in the document with the suggestion of referencing work that is already being done specifically in the area of case definitions and guidelines for adverse events following immunization.

Comments
In various locations throughout the proposed document is guidance given regarding information to be collected on an adverse event to ?focus the line of questioning? for specific events, and the need for case definitions is highlighted. The Brighton Collaboration has created such targeted data collection tools in addition to recommendations for a standardized way to analyze collected data. The Brighton Collaboration also has created and continues to do so standardized case definitions of selective AEFI to standardize and improve our current understanding of these events.
Few international and national surveillance groups have developed case definitions for use in immunization safety7-9. Those developed were neither widely implemented nor do they represent an exhaustive set of definitions, or provide guidelines for the standardized collection, analysis, and presentation of data which are needed to achieve comparability of data. The Brighton Collaboration is filling this need.
We stipulate that in surveillance systems and epidemiologic studies, the documents can be used to assist with follow up on reported cases to get complete information. The definitions or guidelines can also be used to classify coded events in a surveillance database, and to identify useful follow up information on reports of AEFIs. Another envisioned possibility for web-based reporting is to have a ?pop-up window? based on certain key words (e.g., fever) provided by the reporter prompting that reporter for information specified in the respective definition and data collection guidelines. This would allow for more complete information at the reporting level. Standardized case definitions and guidelines are also valuable for case reports, and would help in the overall evaluation in the Periodic Safety Update Reports, if one and the same vocabulary and meaning of
that vocabulary were used.
We believe that the Brighton Collaboration concept of global collaboration and a scientific approach towards best evidence-based standardization of public health tools such as case definitions and guidelines can serve as a model for other areas of medical interventions, especially other domains in patient safety. On behalf of the Brighton Collaboration, I am pleased to submit these comments.