Good publication practice for communicating company sponsored medical research: the GPP2 guidelines

Abstract

Authors and presenters are responsible for how medical research is interpreted and communicated. Often their work is the product of collaborations with other individuals (such as clinical investigators, biostatisticians, and professional medical writers) from around the world. Some or all of the people who contribute to this collaboration may be employees of research sponsors, contract research organisations, or medical communications agencies that may be funded by pharmaceutical, medical device, or biotechnology companies. The authors, collaborators, and organisations share responsibility for developing articles and presentations in a responsible and ethical manner.The good publication practice (GPP2) guidelines presented here make recommendations that will help individuals and organisations maintain ethical practices and comply with current requirements when they contribute to the communication of medical research sponsored by companies. These guidelines apply to peer reviewed journal articles and presentations at scientific congresses. evolving standardsThe conduct and communication of medical research, including that sponsored by companies, continues to be criticised.

Publication planning: promoting an ethics of transparency and integrity in biomedical research

“…Writing should never begin before careful consultation with all authors, who should be informed of their duties well in advance of data availability. Furthermore, professional medical writers should not be engaged unless all authors have had a clear opportunity to opt in or out of receiving such support, particularly when assistance might be reportable, as under the Physician's Payment Sunshine Act, or considered a potential financial bias 6, 7, 11. Publication planning can create an environment in which each participant is confident that work is being undertaken only after appropriate input and permission have been received.…”

Freedom of Science – Can Industry Influence What Scientists Publish?

“…6 Most of these concerns are addressed in good publication guidelines that apply to publications arising from industry-sponsored clinical studies of marketed products with the aim to reduce publication bias. 7,8 Non-publication of Findings that Do Not Support the Sponsor's Marketing Aims Pharmaceutical companies have recently been attracting increasing public criticism and hostility over their failure to publish large quantities of their own data from clinical trials and have been accused of suppressing data unfavourable to their products. [9][10][11][12][13] In any research work involving commercial diagnostic or pharmaceutical products or comparisons of products, the publication of negative data is bound to be disliked and possibly opposed by its respective manufacturers and marketers.…”

Procédure éditoriale en matière de conflits d’intérêts

“…Notre rôle n'est pas de juger ; les rédacteurs en chef doivent se mettre dans la peau du lecteur et rester à l'affût de toute impression de parti pris. Dans le doute, il faut inviter les auteurs à en dire plus que moins 5 . Les rédacteurs en chef du British Journal of Dermatology estiment que la responsabilité de déclaration incombe entièrement aux auteurs.…”