Monday, January 11, 2010

GIDB - Global Integrated Database - Clinical/Regulatory Submission

A point to consider which is often asked and debated by pharma when considering the development, structure and SAP (Statistical Analysis Plan) of the Clinical/Regulatory Submission GIDB (Global Integrated Database). The GIDB is an integrated database which captures all data from Clinical Studies, Phases 1,2,3. The GIDB includes all data for clinical safety and clinical efficacy. FDA will often expect several "GIDBs" - one for safety and one for efficacy. The GIDB for efficacy will include data for Clinical Studies, Phase 2 and 3. The GIDB for safety will include data for Clinical Studies, Phases 1,2,3 - yes, FDA will expect, a GIDB for Phase 1 as well.

It is expected by FDA to "have some pooling across all studies" for Phase 1 safety. Most pharma disagree with the Phase 1 GIDB because they feel that Phase 1 studies are too heterogeneous in design and captures information for safety and tolerability, not detailed , much like a POC study.

However, the FDA explanation and reasoning is that even in Phase 1 an AE (adverse event) may appear and for FDA that is their main concern to make sure ALL AEs are captured, reported, reviewed and researched - the ultimate goal is not to approve a drug - it is patient safety.

Make sure you correspond with FDA, verbally and in writing as to this requirement. It is a point of consideration to the overall filing - it can trigger a RTF (Refusal to File) if FDA requested a Phase 1 GIDB and the pharma company did not include one in the filing.

Careful negotiation with FDA pertaining to the content and the TOC of the GIDB, the pooling is important. The GIDB must carry the "storyline" of the clinical submission and should be equivalent to the eventual message in the label of the drug. With careful planning and clear statistical strategy, one can negotiate with FDA how to present the data in the best way for clarity, however, don't fall short on the importance of including all safety data at all stages of clinical development. Under-reporting for any reason is not tolerated by FDA.

No comments:

Post a Comment