Lower costs & risks associated with indication extensions, thanks to a robust meta-analysis of clinical data

Background

Our client, a large pharmaceutical company operating notably in Oncology, Neurology and Rare Diseases, reached out to us in the context of an indication extension for one of its flagship products.

Challenge

In order to support an indication extension application, our client asked us to carry out a meta-analysis of 17 clinical studies (mostly from internal sources). The objectives were to evaluate the efficiency and safety of the product in the context of its new use.

Approach

1. Writing a Statistical Analysis Plan (SAP), identifying the differences and similarities between the studies and the analyses to be performed. 2. Creation of a pooled ADaM dataset for the meta-analysis. 3. Production of the pooled TFLs (tables, figures, listings). 4. Writing the final meta-analysis report, combining both efficiency and safety results for all subgroups, and reviewed by the project team.

Key results

Benefits

Based on re-used data from 17 studies, this meta-analysis was both less expensive and more statistically representative, than an adhoc study to evaluate the extension of the indication. Keyrus Life Science's expertise was recognized by the client, both in the quality of the statistical analysis and the report delivered, as well as in the management of the project without exceeding the budget or schedule.

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