@article{fdi:010069998,
  title = {{T}he {ADVANCE} {C}ode of {C}onduct for collaborative vaccine studies},
  author = {{K}urz, {X}. and {B}auchau, {V}. and {M}ahy, {P}. and {G}lismann, {S}. and van der {A}a, {L}. {M}. and {S}imondon, {F}ran{\c{c}}ois and {ADVANCE} {C}onsortium,},
  editor = {},
  language = {{ENG}},
  abstract = {{L}essons learnt from the 2009 ({H}1{N}1) flu pandemic highlighted factors limiting the capacity to collect {E}uropean data on vaccine exposure, safety and effectiveness, including lack of rapid access to available data sources or expertise, difficulties to establish efficient interactions between multiple parties, lack of confidence between private and public sectors, concerns about possible or actual conflicts of interest (or perceptions thereof) and inadequate funding mechanisms. {T}he {I}nnovative {M}edicines {I}nitiative's {A}ccelerated {D}evelopment of {VA}ccine benefit-risk {C}ollaboration in {E}urope ({ADVANCE}) consortium was established to create an efficient and sustainable infrastructure for rapid and integrated monitoring of post-approval benefit-risk of vaccines, including a code of conduct and governance principles for collaborative studies. {T}he development of the code of conduct was guided by three core and common values (best science, strengthening public health, transparency) and a review of existing guidance and relevant published articles. {T}he {ADVANCE} {C}ode of {C}onduct includes 45 recommendations in 10 topics ({S}cientific integrity, {S}cientific independence, {T}ransparency, {C}onflicts of interest {S}tudy protocol, {S}tudy report, {P}ublication, {S}ubject privacy, {S}haring of study data, {R}esearch contract). {E}ach topic includes a definition, a set of recommendations and a list of additional reading. {T}he concept of the study team is introduced as a key component of the {ADVANCE} {C}ode of {C}onduct with a core set of roles and responsibilities. {I}t is hoped that adoption of the {ADVANCE} {C}ode of {C}onduct by all partners involved in a study will facilitate and speed-up its initiation, design, conduct and reporting. {A}doption of the {ADVANCE} {C}ode of {C}onduct should be stated in the study protocol, study report and publications and journal editors are encouraged to use it as an indication that good principles of public health, science and transparency were followed throughout the study.},
  keywords = {{C}ode of conduct ; {S}tudy team ; {T}ransparency ; {S}cientific integrity ; {P}ublic health ; {EUROPE}},
  booktitle = {},
  journal = {{V}accine},
  volume = {35},
  numero = {15},
  pages = {1844--1855},
  ISSN = {0264-410{X}},
  year = {2017},
  DOI = {10.1016/j.vaccine.2017.02.039},
  URL = {https://www.documentation.ird.fr/hor/fdi:010069998},
}