Surrogate endpoint evaluation using data from one large global randomized controlled trial.
Milan GeybelsBenjamin Ole WolthersFrederik Flindt KreinerSøren RasmussenRobert BauerPublished in: BMC medical informatics and decision making (2021)
We derived a specific grouping approach to successfully apply SEE on data from a single trial. This may allow for the statistically robust identification and validation of surrogate endpoints based on the abundance of large monolithic outcome trials conducted as part of drug development programmes in, for example, diabetes.
Keyphrases
- randomized controlled trial
- study protocol
- electronic health record
- type diabetes
- big data
- cardiovascular disease
- clinical trial
- systematic review
- phase iii
- glycemic control
- machine learning
- antibiotic resistance genes
- liquid chromatography
- data analysis
- skeletal muscle
- microbial community
- high resolution
- double blind