BACKGROUND: Non-interventional studies (NIS) are an essential post-marketing surveillance tool to generate real-world evidence on the use, effectiveness, and safety of medicines for the benefit of patients. NIS execution should adhere to high-quality standards, based on the recommendations issued by the regulatory authorities to guarantee the achievement of trustworthy results and to ensure traceability. Currently, regulations and guidelines on quality requirements for NIS from different regulatory agencies are mostly focused on improving transparency and promoting critical scientific thinking regarding studydesign and execution. Many requirements and recommendations exist for data quality and statistical methods; however, key performance indicators (KPIs) and the identification of critical success factors are missing for the overall quality compliance assessment of NIS.
OBJECTIVES: This study aims to explore the current gaps in NIS quality management and to develop guidelines and indicators to harmonize the measurement of NIS quality compliance.
METHODS: A qualitative analysis of the whole lifecycle of selected NIS was performed to map quality compliance gaps at the different stages of a study as well as identify critical success factors. Data collection included challenges assessment in NIS preparation and execution and key lessons learnt reports from NIS studies (n=12), as well as focus group discussions (n=2). Data were analyzed thematically.
RESULTS: We have identified overall 10 critical success factors of NIS that could impact the quality of the NIS lifecycle. Moreover, we developed more than 20 quantitative and qualitative KPIs covering different NIS stages. Some of the identified critical success factors and KPIs are original, whereas others have been adjusted from existing guide-lines when the application needs reinforcing.
CONCLUSIONS: The present work is aimed at improving the quality of NIS preparation and execution. The use of KPIs from the current guidelines as part of NIS quality compliance and monitoring will help in delivering higher standards studies and promote quality adherence in the context of post-marketing authorisation monitoring.
