A top tier pharmaceutical company aimed to apply for marketing authorisation for a new oncology therapy six months after database lock on its last pivotal study.

Clinical trials of the drug had been conducted over many years by multiple research organisations, so the data existed in a variety of underlying structures. An unanticipated decision on the part of regulators to include data from certain older studies created extra pressure on the company. It needed to convert the legacy data into the latest data standard (established by CDISC) and harmonise data from 11 studies at the same time that it was preparing its risk management plan and safety updates and planning key scientific meetings.

The company turned to ICON’s dedicated Biostatistics and Programming group to integrate the safety and efficacy data for analysis and, ultimately, inclusion in the submission package. The ICON team:

• Performed an immediate gap analysis to resolve CDISC non-compliance issues, meet medical dictionary up-coding requirements, and identify missing data
• Developed a Study Data Standardization Plan (SDSP) and a statistical analysis plan to direct the programming work
• Converted legacy data to CDISC standards using in-house tools
• Discussed and documented exceptions from the report with the sponsor
• Conducted robust programming with built-in consistency checks

The team worked rapidly to ensure the consistency and harmonisation of data across studies and subgroups because they:

• Relied on a dedicated project manager to serve as the primary point
  of contact with the sponsor and to drive the team’s focus on quality
  and efficiency
• Took advantage of a global team that could carry out parallel work streams

ICON delivered approximately 5,000 data outputs in the form of tables, graphs and listings to the sponsor according to the agreed-upon milestones. The integrated information was presented using consistent formats across studies and was organised to facilitate easy analysis. All deliverables were CDISC compliant, and the documentation was inspection ready, generating no major audit findings. The sponsor and ICON developed a positive working relationship through which the company submitted its application to multiple agencies on time, supported by a high-quality data package. The new oncology therapy was approved for marketing authorisation.