title: The ADVANCE Code of Conduct for collaborative vaccine studies.
abstract: Lessons learnt from the 2009 (H1N1) flu pandemic highlighted factors limiting the capacity to collect European 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. The Innovative Medicines Initiative's Accelerated Development of VAccine benefit-risk Collaboration in Europe (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. The 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. The ADVANCE Code of Conduct includes 45 recommendations in 10 topics (Scientific integrity, Scientific independence, Transparency, Conflicts of interest, Study protocol, Study report, Publication, Subject privacy, Sharing of study data, Research contract). Each topic includes a definition, a set of recommendations and a list of additional reading. The concept of the study team is introduced as a key component of the ADVANCE Code of Conduct with a core set of roles and responsibilities. It is hoped that adoption of the ADVANCE Code of Conduct by all partners involved in a study will facilitate and speed-up its initiation, design, conduct and reporting. Adoption of the ADVANCE Code of Conduct 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.
authors.affiliation: Surveillance & Epidemiology, European Medicines Agency, London, United Kingdom. Electronic address: xavier.kurz@ema.europa.eu.
authors.forename: Xavier
authors.initials: X
authors.lastname: Kurz
authors.affiliation: Vaccine Clinical Safety and Pharmacovigilance, GSK Vaccines, Wavre, Belgium.
authors.forename: Vincent
authors.initials: V
authors.lastname: Bauchau
authors.affiliation: Scientific Institute of Public Health, Brussels, Belgium.
authors.forename: Patrick
authors.initials: P
authors.lastname: Mahy
authors.affiliation: Scientific Affairs & Public Health, Paediatric Vaccines Europe, GSK Vaccines, Wavre, Belgium.
authors.forename: Steffen
authors.initials: S
authors.lastname: Glismann
authors.affiliation: Scientific Institute of Public Health, Brussels, Belgium.
authors.forename: Lieke Maria
authors.initials: LM
authors.lastname: van der Aa
authors.affiliation: Institut de recherche pour le développement (IRD), Paris, France.
authors.forename: François
authors.initials: F
authors.lastname: Simondon
mesh_terms: D032781:Codes of Ethics; D005060:Europe; D006801:Humans; D053118:Influenza A Virus, H1N1 Subtype / Q000276:immunology*; D007252:Influenza Vaccines / Q000008:administration & dosage / Q000276:immunology*; D007251:Influenza, Human / Q000453:epidemiology* / Q000517:prevention & control*; D000070516:Intersectoral Collaboration; D055818:Public-Private Sector Partnerships
chemical_list: D007252:Influenza Vaccines
keywords: Code of conduct; Public health; Scientific integrity; Study team; Transparency