What "Good" RWE Looks Like

Current Tools and Approaches for Broader Adoption

Tools or approaches	Relevance
ADVANCE Code of Conduct for vaccines	Includes 45 recommendations in 10 topics (incl. transparency, conflicts of interest, study protocol and report). Each topic includes a definition, a set of recommendations and a list of additional reading. The concept of the study team is introduced as a key component of the ADVANCE Code of Conduct with a core set of roles and responsibilities for involved stakeholders. Sets principles for independence and transparency in vaccine observational studies Establishes ethical and scientific principles for independently run vaccine studies Requires disclosure of funding, data access rules, and governance
CDAAMC Guidance for Reporting RWE	Comprehensive and fit for purpose reporting guidance - set of common principles and core standards to optimise the utility and transparency of RWE to both HTA and regulatory bodies. Particularly relevant to conduct an end-to-end RWE study Aims at standardised RWE reporting for clinical practice Standardises how RWE is reported, promoting comparability and reducing selective reporting Emphasises clarity in defining populations, endpoints, and data provenance
CONSORT Statement	Provides a structured way to report trials, including pragmatic and hybrid RCT-RWE designs Makes it easier to assess risk of bias and generalisability.
EMA metadata and reporting standards	Developed to provide regulators, researchers (including academia and pharmaceutical industry) and other interested stakeholders with recommendations on the use of the catalogues from the perspective of the data user. Specifically, the guide focuses on describing the steps and best practices on identifying a suitable data source, when planning a study. Defines minimal reporting requirements for submissions and public registries Ensures structured capture of RWE study metadata for regulatory submission Facilitates traceability and replication of findings
ENCePP Code of conduct and checklist for Study Protocols	Encourages reflection on key principles during the design and drafting of a pharmaco-epidemiological or pharmacovigilance study protocols. The Checklist is practical and aims to enhance the quality of these studies rather than to standardise them Ensures completeness, methodological rigor, and transparency in protocol writing Guarantees completeness in protocol design before the study starts Prevents retrospective protocol changes (reducing p-hacking or selective analysis)
ENCePP Guide on Methodological Standards in Pharmacoepidemiology	Harmonises best practices in RWD study methods and provides a common reference for methods (e.g. confounding control, data linkage, causal inference).
Good Pharmacovigilance Practices Module VIII (EMA)	Guidelines on both interventional and non-interventional PASS, with a primary focus on non-interventional ones. Comprehensive framework for the management of Risk Minimisation Measures (RMMs) to ensure that safety risks are effectively communicated and mitigated throughout the product lifecycle, improving patient safety and regulatory compliance. Applies rigorous safety monitoring standards to post-authorisation studies Mandates protocols, data sources, and analytic plans in PASS submissions
ISPOR/ISPE RWE Recommendations (Joint Task Force)	Provide a standardised and transparent framework for generating, analysing, and RWE to support more informed decision-making in healthcare, drug development, and regulatory processes. It fosters consistency and quality across RWE research, which is crucial for integrating real-world data into clinical and policy decisions. Useful for designing comparative effectiveness studies using RWD Encourages detailed documentation of study assumptions and methods
HAS Realworld studies guidance	Provide guidance on conducting and evaluating RWE studies to ensure their scientific rigor, relevance, and value in healthcare decision-making Clarifies how RWE will be evaluated for reimbursement decisions Has a section on developing RWE questions
HARPER Protocol Template	Structure framework designed to facilitate the development of comprehensive and clear research protocols (pharmacovigilance and pharmacoepidemiology studies). Standardised template promoting reproducible RWE study designs Drives consistency and completeness in planning of RWE studies Includes detailed rationale, bias mitigation strategies, and operational planning
NICE RWE framework	Guidance to ensure that the generation and application of RWE are scientifically robust, transparent, and relevant for healthcare decision-making. It is designed to support stakeholders, including regulators, payers, clinicians, and researchers, in systematically producing and evaluating RWE. Lays out clear expectations for acceptable RWE in regulatory/HTA submissions Promotes public registration, protocol sharing, and clarity on data provenance
PICO framework	Simple and powerful tool used to formulate clear, focused clinical questions, especially useful in evidence-based practice. It breaks down complex questions into manageable components Standard question framework improves clarity of intent in research Makes comparator selection and outcome justification explicit
RECORD-PE	Set of guidelines designed to enhance transparency, quality, and reproducibility in pharmaco-epidemiological research relying on routinely collected health data, such as electronic health records, claims data, or registries Enhances transparency in database and registry studies. Encourages detailed reporting on data linkage, population definitions, and missing data
ROBINS-I	Relevant to access the risk of bias in non-randomised studies of interventions. It helps determine the credibility of study findings by systematically evaluating the potential biases across multiple domains. Provides structured bias assessment in non-randomised studies Identifies potential confounding, selection bias, or measurement issues
STaRT-RWE Checklist	Comprehensive framework to design, conduct, and report Real-World Evidence (RWE) studies with clarity, transparency, and consistency. Ensures consistent planning and documentation of implementation studies Reduces ambiguity in study intent and reduces selective reporting
STROBE	Checklist aimed at improving the transparency, completeness, and quality of reporting observational research - including cohort, case-control, and cross-sectional studies Standardises reporting structure, enabling reviewers to assess validity
Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use	Legislation underpinning Good Pharmacovigilance Practices Module VIII

This page belongs to a series of pages about the IDERHA report "Recommendations on policies to support the acceptance of heterogeneous health data research in regulatory and HTA decision-making", published in November 2025. The full report is available as a PDF, or you can visit the page with an executive summary.