Année
2022
Auteurs
PUYOU DE POUVOURVILLE Gérard, SIGURÐARDÓTTIR K, SOLA-MORALES O, MURPHY LA, CORRY S, MESTRE-FERRANDIZ J, CUNNINGHAM D, AKEHURST R
Abstract
Real-World Data (RWD) and Real-World Evidence (RWE) can provide extensive information on health care to use in HTA and regulatory decision-making. However, there is a lack of consensus surrounding the appropriate data governance practices for RWD/E. Data sharing is also a large concern, especially considering novel data protection regulations (GDPR). Our objective is to propose recommendations for international standards of evaluating the acceptability of RWD governance practices. These could benefit all RWD users, such as public/private researchers, data managers and regulatory/HTA assessment bodies.
SIGURÐARDÓTTIR, K., SOLA-MORALES, O., MURPHY, L., CORRY, S., MESTRE-FERRANDIZ, J., CUNNINGHAM, D. … PUYOU DE POUVOURVILLE, G. (2022). POSB405 Data Governance for Rwd/E Management: Optimising Its Use in HTA and Decision-Making. Dans: Virtual ISPOR Europe 2021 Meeting.