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 Access to unpublished trial information should be open and timely to support decision-making for patients.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
- end stage renal disease
- decision making
- study protocol
- chronic kidney disease
- double blind
- newly diagnosed
- phase ii
- prognostic factors
- health information
- minimally invasive
- peritoneal dialysis
- healthcare
- randomized controlled trial
- artificial intelligence
- patient reported
- machine learning
- adverse drug
- deep learning
- drug administration
- placebo controlled