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

Helen Dolk, Rosa Gini, Xavier Fournie, Xavier Kurz, Patrice Verpillat, Francois Simondon, Valerie Strassmann, Kathi Apostolidis, Thomas Goedecke

Research output: Contribution to journalReview article

1 Citation (Scopus)
32 Downloads (Pure)

Abstract

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 post-authorisation 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 non-interventional 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 non-interventional research.
Original languageEnglish
Pages (from-to)422-433
Number of pages12
JournalPharmacoepidemiology and Drug Safety
Volume28
Issue number4
Early online date5 Mar 2018
DOIs
Publication statusPublished - 1 Apr 2019

Keywords

  • conflict of interest
  • ethics
  • observational studies as topic
  • pharmacoepidemiology
  • pharmacovigilance
  • practise guideline
  • research

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