ReviewPharmacoepidemiology and drug safety2019
The ENCePP Code of Conduct: A best practise for scientific independence and transparency in noninterventional postauthorisation studies.
Review in Pharmacoepidemiology and drug safety, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers.
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Who cites it
10 citing papers in PubMed.
- Strengthening Pharmacoepidemiology in a Changing Research Environment: The European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP).Pharmacoepidemiology and drug safety · 2025Review
- The Urticaria Voices Study: Physicians' Perspectives on the Real-World Patient Burden, Treatments, and Outcomes in Chronic Spontaneous Urticaria.Dermatology and therapy · 2025Article
- Article
- Transparency in the secondary use of health data: assessing the status quo of guidance and best practices.Royal Society open science · 2025Article
- Identifying regulatory outcomes of Non-interventional Post-Authorisation Safety Studies (PASS) in the European repository of studies using publicly available information.Frontiers in drug safety and regulation · 2025Article
- Article
- HARmonized Protocol Template to Enhance Reproducibility of hypothesis evaluating real-world evidence studies on treatment effects: A good practices report of a joint ISPE/ISPOR task force.Pharmacoepidemiology and drug safety · 2023Article
- Overview of the European post-authorisation study register post-authorization studies performed in Europe from September 2010 to December 2018.Pharmacoepidemiology and drug safety · 2022Article
- Different Strategies to Execute Multi-Database Studies for Medicines Surveillance in Real-World Setting: A Reflection on the European Model.Clinical pharmacology and therapeutics · 2020Review
- The ENCePP Code of Conduct: A best practise for scientific independence and transparency in noninterventional postauthorisation studies.Pharmacoepidemiology and drug safety · 2019Review
Corrections and comments
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Authors and funding
9 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
purposeThe ENCePP Code of Conduct provides a framework for scientifically independent and transparent pharmacoepidemiological research. Despite becoming a landmark reference, practical implementation of key provisions was still limited. The fourth revision defines scientific independence and clarifies uncertainties on the applicability to postauthorisation safety studies requested by regulators. To separate the influence of the funder from the investigator's scientific responsibility, the Code now requires that the lead investigator is not employed by the funding institution.
methodTo assess how the revised Code fits the ecosystem of noninterventional pharmacoepidemiology research in Europe, we first mapped key recommendations of the revised Code against ISPE Good Pharmacoepidemiology Practices and the ADVANCE Code of Conduct. We surveyed stakeholders to understand perceptions on its value and practical applicability. Representatives from the different stakeholders' groups described their experience and expectations.
resultsUnmet needs in pharmacoepidemiological research are fulfilled by providing unique guidance on roles and responsibilities to support scientific independence. The principles of scientific independence and transparency are well understood and reinforce trust in study results; however, around 70% of survey respondents still found some provisions difficult to apply. Representatives from stakeholders' groups found the new version promising, although limitations still exist.
conclusionBy clarifying definitions and roles, the latest revision of the Code sets a new standard in the relationship between investigators and funders to support scientific independence of pharmacoepidemiological research. Disseminating and training on the provisions of the Code would help stakeholders to better understand its advantages and promote its adoption in noninterventional research.
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