Survey of Safety Information in the Investigator's Brochure: Inconsistencies and Recommendations.

A survey was undertaken to gain an understanding of current industry practices in the preparation of the safety information for the Investigator's Brochure (IB). Sixteen of a potential 25 respondents completed a survey (64% response rate). Five respondents represented pharmaceutical and biotech companies, and 11 were consultants or worked at contract research organizations for such companies. The results showed a lack of uniformity of practices. This may be due to the lack of harmonized regulations and guidelines, the lack of standardized terminology and definitions, and the lack of clarity regarding the purpose and content of the various safety-related sections of the IB. These sections, although interrelated, have different purposes, and the criteria and methodology used have to be appropriate for these purposes. It is recommended that regulations, guidelines, and terminology be harmonized worldwide to enable consistent reporting to regulatory authorities across regions, minimize duplication of work for companies that operate in different regions, and to provide meaningful safety information both to the investigator and regulatory authorities. Recently published information regarding the format and the content of a "Reference Safety Information" section provides clarity for this element of the IB, which can hopefully be adopted globally. Until further regulatory clarity is provided for other safety sections, recommended approaches are provided.