How 4 Companies Became One: Co-development Under an Outsourced Model With Focus on Phase 3 Analysis and Reporting Deliverables

Abstract

With the growth in co-development deals between pharmaceutical companies and the increased use of contract research organizations (CROs) in drug development, more and more employees are encountering projects that require working across different companies. Navigating the mix of corporate cultures as well as variations in standards and procedures can lead to unanticipated challenges and delays. The development of ertugliflozin, a recently approved medicine for type 2 diabetes mellitus, involved both co-development and CRO engagement across 4 companies. Challenges to combining processes and systems across the 4 companies were encountered and resolved. Early decisions for adoption of standards and processes as well as the organization of committees and communication pathways were key to the success of this ambitious program. Here we share our experiences and lessons learned with respect to the analysis and reporting of clinical trial results.

Statistical Analysis in Clinical Trials Using the Study Data Tabulation Model (SDTM) and the Analysis Dataset Model (ADaM): Effects, Obstacles, and Solutions

“…For instance, three parameters that are frequently employed are "Overall Survival Time (Months)", "Progression Free Survival Time (Months)", and "Duration of Response (Months)". The initial two parameters are calculated for all subjects included in the intent-to-treat analysis, while the third parameter is only calculated for subjects who achieved a complete response (CR) or partial response (PR) in the ADaM dataset ADEF [54,55]. These subjects are identified by having a value of 'Y' in the EFORFL variable in ADEF.…”