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Clinical study reports published by the European Medicines Agency....pdf (1.42 MB)

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

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journal contribution
posted on 2023-06-28, 15:32 authored by David ByrneDavid Byrne, Ciaran Prendergast, Tom FaheyTom Fahey, Frank MoriartyFrank Moriarty

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 that were submitted for regulatory drug approval. Submissions were for initial marketing authorisations in 64.1%. There was a median of 15 (IQR 5-46) documents, 5 (IQR 2-14) trials and 9629 (IQR 2711-26,673) pages per submission, and a median of 1 (IQR 1-4) document and 336 (IQR 21-1192) pages per trial. Of all identified pivotal trials, 60.9% were phase 3 and 18.5% were phase 1. Of 119 unique submissions to the EMA, 46.2% were supported by a single pivotal trial, with 13.4% based on a single pivotal phase 1 trial. No trial registry results were identified for 26.1% trials, no journal publications for 16.7% and 13.5% of trials had neither. EMA publication was the earliest information source for 5.8% of pivotal trials, available a median 523 days (IQR 363-882 days) before the earliest publication.

Conclusions: The EMA Clinical Data website contains lengthy clinical trial documents. Almost half of submissions to the EMA were based on single pivotal trials, many of which were phase 1 trials. CSRs were the only source and a timelier source of information for many trials. Access to unpublished trial information should be open and timely to support decision-making for patients.

Funding

Health Research Board of Ireland as part of the RightCare Collaborative Doctoral Award (funding reference CDA-2018-005)

History

Data Availability Statement

Data are available in a public, open access repository. All data used in this study are publicly available from the EMA at: https://clinicaldata.ema.europa.eu/web/cdp/home. Extracted data from this study are available at: https://doi.org/10.5281/zenodo.7700338

Comments

The original article is available at https://bmjopen.bmj.com/

Published Citation

Byrne D, Prendergast C, Fahey T, Moriarty F. Clinical study reports published by the European Medicines Agency 2016-2018: a cross-sectional analysis. BMJ Open. 2023;13(5):e068981.

Publication Date

15 May 2023

PubMed ID

37188475

Department/Unit

  • General Practice
  • HRB Centre for Primary Care Research
  • School of Pharmacy and Biomolecular Sciences

Publisher

BMJ Publishing Group Ltd,

Version

  • Published Version (Version of Record)