INNODIA Master Protocol for the evaluation of investigational medicinal products in children, adolescents and adults with newly diagnosed type 1 diabetes.
David B DungerSylvaine F A BruggraberAdrian P ManderMaria Loredana MarcovecchioTimothy TreePiotr Jaroslaw ChmuraMikael KnipAnke M SchulteChantal Mathieunull nullPublished in: Trials (2022)
The Master Protocol provides (1) standardised assessment of efficacy and safety, (2) comparable collection of mechanistic data, (3) the opportunity to include adaptive designs and the use of shared control groups in the evaluation of combination therapies, and (4) benefits of greater understanding of endpoint variation to ensure more robust sample size calculations and future baseline stratification using existing and novel biomarkers.
Keyphrases
- newly diagnosed
- young adults
- type diabetes
- randomized controlled trial
- physical activity
- density functional theory
- electronic health record
- molecular dynamics
- current status
- molecular dynamics simulations
- big data
- insulin resistance
- clinical trial
- metabolic syndrome
- skeletal muscle
- open label
- artificial intelligence
- weight loss
- monte carlo
- finite element analysis
- drug discovery