Sharing and reuse of individual participant data from clinical trials: principles and recommendations.
Christian OhmannRita BanziSteve CanhamSerena BattagliaMihaela MateiChristopher AriyoLauren BecnelBarbara BiererSarion BowersLuca ClivioMonica DiasChristiane DrumlHélène FaureMartin FennerJose GalvezDavina GhersiChristian GluudTrish GrovesPaul HoustonGhassan KaramDipak KalraRachel Louise KnowlesKarmela Krleža-JerićChristine KubiakWolfgang KuchinkeRebecca KushAri LukkarinenPedro Silverio MarquesAndrew NewbiggingJennifer O'CallaghanPhilippe RavaudIrene SchlünderDaniel ShanahanHelmut SitterDylan SpaldingCatrin Tudur-SmithPeter van ReuselEvert-Ben van VeenGerben Rienk VisserJulia WilsonJacques Demotes-MainardPublished in: BMJ open (2017)
The adoption of the recommendations in this document would help to promote and support data sharing and reuse among researchers, adequately inform trial participants and protect their rights, and provide effective and efficient systems for preparing, storing and accessing data. The recommendations now need to be implemented and tested in practice. Further work needs to be done to integrate these proposals with those from other geographical areas and other academic domains.