Problem Statement: Planning and conducting multi-country real-world (RW) observational studies requires significant attention, in order to avoid potential pitfalls and challenges that may arise in the conduct of these studies.

Description: In a recent oncology study involving 7 countries across different continents, our team was tasked with developing a systematic approach to plan and conduct this RW observational study. A multi-step approach was designed with clear objectives. The first step was to develop and validate the proposed data model including comprehensive data protection analysis on all features, types and definitions of variables that will be captured, required impact assessments, data flow maps, etc., in each country. The second step consisted of developing a framework to guide key steps needed for compliance to patient privacy and data protection (PPDP) issues in each country, including handling of data portability and report dissemination. The third step was to design the process for data capture, data analytics, reporting and archiving of data, along with security and quality assurance processes at each step based on the validated data model.

Lessons Learned: In anticipation of the challenge of target countries being hesitant to transfer and sharing patient data, the team reviewed potential alternative approaches to extract the needed data to complete the study. Based on this assessment, the team developed a plan to generate synthetic data analogues of the raw patient data files to address this challenge, along with adaptations in the analysis plan and reporting of study findings. Two target countries were chosen as pilot sites based on their suitability to field test the processes of data collection, data transfer, analysis, and reporting.

Stakeholder Perspective: A multi-step approach that focuses on data management and patients’ fundamental rights for privacy are critically important to avoid delays, additional costs, legal and non-compliance risks associated with multi-country studies.