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Building Teams to Handle Unexpected Regulatory Agency Requests

Not long ago, one of our clients submitted Phase 2 and Phase 3 data for a new rare disease drug which had received priority review status. Following submission, regulators requested that our client also submit pooled data from its Phase 1 studies along with a safety analysis. This analysis had the potential to clinch NDA approval for the new product.

Unfortunately, our client had conducted thirteen Phase 1 trials for the drug, each of which had a different design, was of a different size, and had a different data structure. The statistical challenge of pooling data from thirteen different trials with different designs and structures is easy to imagine. The specific purpose of each trial and the particularities of the design had to be understood, and then translated into ADaM (Analysis Data Model).

Adding to the problem, however, was a tight timeframe in which to complete the project. The FDA wanted the pooled data as well as the safety analysis, within six weeks of the request.

Such an unexpected agency request demonstrates one of the reasons why streamlining data management with biometrics is an important strategy for securing timely regulatory approval. Given the number of potential requests a regulatory body could potentially make, having a team which knows your data and is able to quickly manage and analyze it, can ensure the management of unexpected agency requests.

It also highlights the importance of hiring a CRO with a “No Excuses” approach to meeting deadlines and deliverables. High quality analyses in a timely matter are always important, but especially so when strict regulatory deadlines are in place.


Related Items of Interest

[1] Regulation and Reproducibility: Can You Reproduce Your Clinical Trial Results?

[2] Data Management & Biostatistics I: Improving Trial Quality

[3] Data Management & Biostatistics II: Operational Benefits of Bundling

[4] Data Management and Biostatistics III: Statistical Innovation in Clinical Data Management

[5]You Own This!


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