Clinical study reports published by the European Medicines Agency 2016–2018: a cross-sectional analysis
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 a...
| Main Authors: | , , , |
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| Format: | Article |
| Language: | English |
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BMJ Publishing Group
2023-05-01
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| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/13/5/e068981.full |
| _version_ | 1797826546193399808 |
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| author | Frank Moriarty Tom Fahey David Byrne Ciaran Prendergast |
| author_facet | Frank Moriarty Tom Fahey David Byrne Ciaran Prendergast |
| author_sort | Frank Moriarty |
| collection | DOAJ |
| description | 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. |
| first_indexed | 2024-04-09T12:34:07Z |
| format | Article |
| id | doaj.art-37717340240c4168861ca74caf91dd49 |
| institution | Directory Open Access Journal |
| issn | 2044-6055 |
| language | English |
| last_indexed | 2024-04-09T12:34:07Z |
| publishDate | 2023-05-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Open |
| spelling | doaj.art-37717340240c4168861ca74caf91dd492023-05-15T21:00:07ZengBMJ Publishing GroupBMJ Open2044-60552023-05-0113510.1136/bmjopen-2022-068981Clinical study reports published by the European Medicines Agency 2016–2018: a cross-sectional analysisFrank Moriarty0Tom Fahey1David Byrne2Ciaran Prendergast32School of Pharmacy and Biomolecular Sciences, Royal College of Surgeons in Ireland, Dublin, Ireland1Department of General Practice, Royal College of Surgeons in Ireland, Dublin, Ireland1Department of General Practice, Royal College of Surgeons in Ireland, Dublin, Ireland2School of Pharmacy and Biomolecular Sciences, Royal College of Surgeons in Ireland, Dublin, IrelandObjectives 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.https://bmjopen.bmj.com/content/13/5/e068981.full |
| spellingShingle | Frank Moriarty Tom Fahey David Byrne Ciaran Prendergast Clinical study reports published by the European Medicines Agency 2016–2018: a cross-sectional analysis BMJ Open |
| title | Clinical study reports published by the European Medicines Agency 2016–2018: a cross-sectional analysis |
| title_full | Clinical study reports published by the European Medicines Agency 2016–2018: a cross-sectional analysis |
| title_fullStr | Clinical study reports published by the European Medicines Agency 2016–2018: a cross-sectional analysis |
| title_full_unstemmed | Clinical study reports published by the European Medicines Agency 2016–2018: a cross-sectional analysis |
| title_short | Clinical study reports published by the European Medicines Agency 2016–2018: a cross-sectional analysis |
| title_sort | clinical study reports published by the european medicines agency 2016 2018 a cross sectional analysis |
| url | https://bmjopen.bmj.com/content/13/5/e068981.full |
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