International Regulatory Guidance - EMEA ICH E9

The international regulatory guidance pertaining to the creation and development of the Global Integrated Database (GIDB) for clinical submission is EMEA ICH E9. When creating the GIDB and Integrated SAP (Statistical Analysis Plan), while utilizing the guidance provided in EMEA ICH E9 - it is important to develop a strong:

• methodological approach
• statistical analysis plan that will demonstrate significance pertaining to objectives and endpoints
• appropriate and version specific and accurate tools for programming TLGFs (Tables, Listings, Graphs and Figures) - SAS Version 9.1 and 8.2, current and previous version, respectively
• standardized, validated program of analysis
• QMP - Quality Management Plan
• "Change" Plan - how to manage
• GIDB Mapping Plan
• GIDB Coding Plan
• GIDB CDISC
• GIDB Dictionaries, MedDRA, WHODRL, etc.

The guidance will "suggest" the creation of two SAPs for the GIDB - one developed for the programming, presentation and pooling strategies for safety data and one for efficacy data. It is important to communicate with FDA early in the development of each GIDB SAP to agree on the programming, presentation and pooling strategies pertaining to clinical submission data. Communication with FDA concerning the GIDB can begin as early as the End of Phase 2 Clinical Studies or at the beginning of the Clinical Phase 3 Program when the "final marketing image" of the investigational drug is clear and decided and the dosing, safety and efficacy objectives and endpoints are final.