OBJECTIVES: To conduct a review of different stakeholders’ policies and perspectives on using Real-World Data (RWD) for early drug development and clinical effectiveness assessment in order to shed light on the possibilities for the incorporation of RWD and Real-World Evidence (RWE) in both aspects. METHODS: A qualitative methodology was selected that combines semi-structured interviews with  a literature review. 19 stakeholders from 8 different stakeholder groups were interviewed. Meanwhile, a review of academic and grey literature was performed. Transcripts of interviews and data from review articles were subjected to coding analysis. Analysis focused on: definitions for RWD provided, current policies on RWD, context (actual & perceived) for RWD use, advantages and disadvantages of RWD, practical obstacles to using RWD, and political and procedural implications for RWD incorporation. RESULTS: Consensus regarding the definition of RWD and types of RWD was lacking among stakeholders. A current gap in policies addressing RWD also exists. Despite this, RWD is currently used for reimbursement, regulatory and drug development processes. RWD has high external validity & generalisability and can provide valuable data on long-term outcomes. Yet biases in data, poor data quality (completeness, comprehensiveness) and lack of standardisation entice scepticism for its use. Ambiguity still remains on governance of RWD/RWE as well as a cultural barrier among stakeholders against the use of RWD/RWE. CONCLUSIONS: Increased stakeholder collaboration is needed to harmonise definitions and evidence needs of RWD, reach consensus on the relevance of RWD for addressing specific questions, and to standardise RWD data collection and analysis methods.