(P-335) Pilot Study Rectifies Real World Study Design to Support Regulatory Decision Making

Background: Economic and time constraints may incite researchers to avoid formalized pilot-studies. Here, we report results of a pilot study which rectified the ensuing DUS protocol, thus ascertaining fit-for-purpose data availability and quality, supporting regulatory decision making.

Objectives: To evaluate the feasibility of a Drug Utilization Study (DUS) investigating real-world use of Saxenda® and Victoza® in Europe.

Methods: A retrospective multi-center medical chart review in Germany and Italy, 6 months after Saxenda (liraglutide, once-daily human GLP-1 analogue, 3.0 mg for weight management) launch, ahead of a full DUS.
Collected data included: Site characteristics, patient demographics, medical history, drug utilization (e.g. brand, dose, indication, weight-related comorbidities).
Target study population: 100 initiators (25 Saxenda initiators and 25 Victoza initiators in both Germany and Italy).
Informed consent was obtained before medical chart data extraction.

Results: 218 sites were contacted.15 sites (Italy (9) and Germany (6)) enrolled initiators. There were 39 Saxenda initiators (33 in Italy; 6 in Germany) and 52 Victoza initiators (31 in Italy; 21 in Germany).
Data was available for all Saxenda initiators and all Victoza initiators in Italy; and for 12 of 21 Victoza initiators in Germany. In 9 of the 12 initiators only target dose was recorded and with no current dose provided.

Conclusions: The pilot study indicated a poor enrollment feasibility of Saxenda initiators in Germany, and an unfit-for-purpose dose-related data quality. Based on these findings, refinements were implemented to the ensuing DUS protocol, thus ensuring robust real-world data to support regulatory decision making.