European Medicines Agency Policy 0070: an exploratory review of data utility in clinical study reports for academic research.

ABSTRACT: BACKGROUND:Clinical study reports (CSRs) have been increasingly utilised within academic research in recent years. European Medicines Agency (EMA) Policy 0070 'Phase 1,' which came into effect in January 2015, requires the publication of regulatory documents such as CSRs from central applications in an anonymised format. EMA Policy 0070 requires sponsors to demonstrate careful consideration of data utility within anonymised CSRs published within the scope of the policy, yet the concept of data utility is not clearly defined in the associated anonymisation guidance. OBJECTIVE:To review the use of data from CSRs in published academic research and to hypothesise the potential data utility of CSRs anonymised under the objectives of EMA Policy 0070 for future academic research. METHODS:Review o

SUBMITTER: Ferran JM 

PROVIDER: S-EPMC6833240 | biostudies-literature | 2019 Nov

REPOSITORIES: biostudies-literature