Clinical study reports published by the European Medicines Agency 2016-2018: a cross-sectional analysis.
David ByrneCiaran PrendergastTom FaheyFrank MoriartyPublished in: BMJ open (2023)
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 Access to unpublished trial information should be open and timely to support decision-making for patients.
Keyphrases
- clinical trial
- decision making
- end stage renal disease
- ejection fraction
- study protocol
- phase ii
- newly diagnosed
- randomized controlled trial
- phase iii
- health information
- minimally invasive
- prognostic factors
- systematic review
- machine learning
- electronic health record
- emergency department
- patient reported
- deep learning
- data analysis