@article{fdi:010075717,
  title = {{T}he {ENC}e{PP} {C}ode of {C}onduct : a best practise for scientific independence and transparency in noninterventional postauthorisation studies},
  author = {{G}ini, {R}. and {F}ournie, {X}. and {D}olk, {H}. and {K}urz, {X}. and {V}erpillat, {P}. and {S}imondon, {F}ran{\c{c}}ois and {S}trassmann, {V}. and {A}postolidis, {K}. and {G}oedecke, {T}.},
  editor = {},
  language = {{ENG}},
  abstract = {{P}urpose: {T}he {ENC}e{PP} {C}ode of {C}onduct provides a framework for scientifically independent and transparent pharmacoepidemiological research. {D}espite becoming a landmark reference, practical implementation of key provisions was still limited. {T}he fourth revision defines scientific independence and clarifies uncertainties on the applicability to postauthorisation safety studies requested by regulators. {T}o separate the influence of the funder from the investigator's scientific responsibility, the {C}ode now requires that the lead investigator is not employed by the funding institution. {M}ethod: {T}o assess how the revised {C}ode fits the ecosystem of noninterventional pharmacoepidemiology research in {E}urope, we first mapped key recommendations of the revised {C}ode against {ISPE} {G}ood {P}harmacoepidemiology {P}ractices and the {ADVANCE} {C}ode of {C}onduct. {W}e surveyed stakeholders to understand perceptions on its value and practical applicability. {R}epresentatives from the different stakeholders' groups described their experience and expectations. {R}esults: {U}nmet needs in pharmacoepidemiological research are fulfilled by providing unique guidance on roles and responsibilities to support scientific independence. {T}he 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. {R}epresentatives from stakeholders' groups found the new version promising, although limitations still exist. {C}onclusion: {B}y clarifying definitions and roles, the latest revision of the {C}ode sets a new standard in the relationship between investigators and funders to support scientific independence of pharmacoepidemiological research. {D}isseminating and training on the provisions of the {C}ode would help stakeholders to better understand its advantages and promote its adoption in noninterventional research.},
  keywords = {conflict of interest ; ethics ; observational studies as topic ; pharmacoepidemiology ; pharmacovigilance ; practise guideline ; research ; {EUROPE}},
  booktitle = {},
  journal = {{P}harmacoepidemiology and {D}rug {S}afety},
  volume = {28},
  numero = {4},
  pages = {422--433},
  ISSN = {1053-8569},
  year = {2019},
  DOI = {10.1002/pds.4763},
  URL = {https://www.documentation.ird.fr/hor/fdi:010075717},
}