Strengthening standards, transparency, and collaboration to support medicine evaluation: Ten years of the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP)

Kurz, Xavier; Perez‐Gutthann, Susana

doi:10.1002/pds.4381

Cited by 33 publications

(33 citation statements)

References 18 publications

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“…The ENCePP Working Group ‘Data Sources’ 9 reviewed an initial version of the inventory with the description of databases and endorsed the final inventory.…”

Section: Methodsmentioning

confidence: 99%

“… 13 The speed at which the results could be generated is an additional important consideration, particularly for regulatory purpose. 9 14 15 By considering the characteristics of the data sources and the research objectives to be addressed, the investigators should be able to choose the most appropriate resource(s) to address the question at hand. However, while some authors provide a detailed description of the databases used in their study, 16–19 in other cases the description is often incomplete, and a justification for their choice in the context of alternative data sources is rarely provided.…”

Section: Introductionmentioning

confidence: 99%

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Electronic healthcare databases in Europe: descriptive analysis of characteristics and potential for use in medicines regulation

Păcurariu¹,

Plueschke²,

McGettigan

et al. 2018

BMJ Open

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ObjectiveElectronic healthcare databases (EHDs) are useful tools for drug development and safety evaluation but their heterogeneity of structure, validity and access across Europe complicates the conduct of multidatabase studies. In this paper, we provide insight into available EHDs to support regulatory decisions on medicines.MethodsEHDs were identified from publicly available information from the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance resources database, textbooks and web-based searches. Databases were selected using criteria related to accessibility, longitudinal dimension, recording of exposure and outcomes, and generalisability. Extracted information was verified with the database owners.ResultsA total of 34 EHDs were selected after applying key criteria relevant for regulatory purposes. The most represented regions were Northern, Central and Western Europe. The most frequent types of data source were electronic medical records (44.1%) and record linkage systems (29.4%). The median number of patients registered in the 34 data sources was 5 million (range 0.07–15 million) while the median time covered by a database was 18.5 years. Paediatric patients were included in 32 databases (94%). Completeness of information on drug exposure was variable. Published validation studies were found for only 17 databases (50%). Some level of access exists for 25 databases (73.5%), and 23 databases (67.6%) can be linked through a personal identification number to other databases with parent–child linkage possible in 7 (21%) databases. Eight databases (23.5%) were already transformed or were in the process of being transformed into a common data model that could facilitate multidatabase studies.ConclusionA Few European databases meet minimal regulatory requirements and are readily available to be used in a regulatory context. Accessibility and validity information of the included information needs to be improved. This study confirmed the fragmentation, heterogeneity and lack of transparency existing in many European EHDs.

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“…The ENCePP Working Group ‘Data Sources’ 9 reviewed an initial version of the inventory with the description of databases and endorsed the final inventory.…”

Section: Methodsmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Electronic healthcare databases in Europe: descriptive analysis of characteristics and potential for use in medicines regulation

Păcurariu¹,

Plueschke²,

McGettigan

et al. 2018

BMJ Open

Self Cite

View full text Add to dashboard Cite

show abstract

“…This is another critical aspect of the learning healthcare system. The European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP) collaboration coordinated by the European Medicines Agency (EMA) has elaborated a Code of Conduct 32 and other guidance 33 aiming to enable public-private collaboration by directly addressing and managing potential conflict of interest issues.…”

Section: Highlighting Best Practicesmentioning

confidence: 99%

Data Rich, Information Poor: Can We Use Electronic Health Records to Create a Learning Healthcare System for Pharmaceuticals?

Eichler¹,

Bloechl-Daum

Broich

et al. 2018

Clin Pharma and Therapeutics

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Judicious use of real-world data (RWD) is expected to make all steps in the development and use of pharmaceuticals more effective and efficient, including research and development, regulatory decision making, health technology assessment, pricing, and reimbursement decisions and treatment. A "learning healthcare system" based on electronic health records and other routinely collected data will be required to harness the full potential of RWD to complement evidence based on randomized controlled trials. We describe and illustrate with examples the growing demand for a learning healthcare system; we contrast the exigencies of an efficient pharmaceutical ecosystem in the future with current deficiencies highlighted in recently published Organisation for Economic Co-operation and Development (OECD) reports; and we reflect on the steps necessary to enable the transition from healthcare data to actionable information. A coordinated effort from all stakeholders and international cooperation will be required to increase the speed of implementation of the learning healthcare system, to everybody's benefit.

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“…Since its beginning, the ENCePP network has served as support for the European regulatory environment in the field of epidemiology. 1,15,16 The ENCePP network has also helped to facilitate the introduction of amended regulatory concepts and amended frameworks specifically in the field of epidemiology for the conduct of postauthorisation safety studies (PASS), and especially following also regulatory requirements coming into force with the EU pharmacovigilance legislation in 2012. [17][18][19] Evolution of the ENCePP network continues to support the work of EU regulatory agencies mirroring also the increased demand for generation of post-approval data.…”

Section: Regulatory Perspectivementioning

confidence: 99%

The ENCePP Code of Conduct: A best practise for scientific independence and transparency in noninterventional postauthorisation studies

Gini

Fournie²,

Dolk

et al. 2019

Pharmacoepidemiology and Drug

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Purpose The 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. Method To 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. Results Unmet 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. Conclusion By 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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Strengthening standards, transparency, and collaboration to support medicine evaluation: Ten years of the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP)

Cited by 33 publications

References 18 publications

Electronic healthcare databases in Europe: descriptive analysis of characteristics and potential for use in medicines regulation

Electronic healthcare databases in Europe: descriptive analysis of characteristics and potential for use in medicines regulation

Data Rich, Information Poor: Can We Use Electronic Health Records to Create a Learning Healthcare System for Pharmaceuticals?

The ENCePP Code of Conduct: A best practise for scientific independence and transparency in noninterventional postauthorisation studies

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