当前位置： SCI文献检索 > BMC Medical Research Methodology期刊下所有文献 > European Medicines Agency Policy 0070: an exploratory review of data utility in clinical study reports for academic research.

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 METHODS:Review of the objectives, research methodologies and findings of academic research reports using unpublished data from CSRs (prior to EMA Policy 0070). Semi-structured interviews with authors of academic research reports, including questions related to data utility of anonymised CSRs published under EMA Policy 0070. RESULTS:Thirteen academic research reports were identified and reviewed. The research purposes ranged from assessment of reporting bias, comparison of methods and results with published data sources, detailed evaluation of harms and adverse events, re-analysis and novel analyses including systematic reviews and meta-analysis. All of the examples identified required access to the methods and results sections of CSRs (including aggregated summary tables) and research purposes relating to evaluation of adverse events also required access to participant narratives. Retaining anonymised participant narratives relating to interventions, findings and events, while maintaining an acceptably low risk of participant re-identification, may provide an important gain in data utility and further understanding of drug safety profiles. CONCLUSIONS:This work provides an initial insight into the previous use of CSR data and current practices for including regulatory data in academic research. This work also provides early guidance to qualitatively assess and document data utility within anonymised CSRs published under EMA Policy 0070.

journal_name

BMC Med Res Methodol

journal_title

BMC medical research methodology

authors

Ferran JM,Nevitt SJ

doi

10.1186/s12874-019-0836-3

subject

Has Abstract

pub_date

2019-11-05 00:00:00

pages

204

issue

issn

1471-2288

pii

10.1186/s12874-019-0836-3

journal_volume

pub_type

杂志文章,评审

在线工具

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