Clinical study reports published by the European Medicines Agency 2016-2018: a cross-sectional analysis.

ABSTRACT:

Objectives

To describe the characteristics of clinical study report (CSR) documents published by the European Medicines Agency (EMA), and for included pivotal trials, to quantify the timeliness of access to trial results from CSRs compared with conventional published sources.

Design

Cross-sectional analysis of CSR documents published by the EMA from 2016 to 2018.

Methods

CSR files and medication summary information were downloaded from the EMA. Individual trials in each submission were identified using document filenames. Number and length of documents and trials were determined. For pivotal trials, trial phase, dates of EMA document publication and matched journal and registry publications were obtained.

Results

The EMA published documents on 142 medications t

SUBMITTER: Byrne D 

PROVIDER: S-EPMC10186437 | biostudies-literature | 2023 May

REPOSITORIES: biostudies-literature