Surrogate endpoints Validation study applicable to the disease, its severity, the intervention, and the comparator required (exception: very serious diseases).
Upper and lower ranges are shown for each risk factor exerting most influence on prediction validation endpoint.
With BR_E_Model to endpoint D, the internal validation result is 0.142, and validation result for validation dataset is 0.349.
In this summary, information from published studies is used as a basis to critique clinical trial designs and to suggest experimental endpoints for future validation studies.
A total of 100 validation endpoints were simulated across treatment arms of twelve pivotal T2DM outcomes studies.
In 90% of validation endpoints, sampled values within 2 standard errors of the mean (as reported by UKPDS) would have resulted in predicted endpoints lying on the 45º identity line.
The primary clinical endpoints in the validation datasets include disease-specific survival (DSS), disease-free survival (DFS), distant metastasis-free survival (DMFS), overall survival (OS), relapse-free survival (RFS), and distant relapse-free survival (DRFS).
These were calculated by comparing X (the predicted endpoints from the Cardiff Model) with Y (the observed endpoints reported in each trial): X1, X2,…, X n and Y1, Y2,…, Y n, where n is the sample size (the number of validation endpoints).
A total of 100 validation endpoints were simulated across treatment arms of twelve pivotal T2DM outcomes studies, simulation cohorts representing each validation study's cohort profile were generated and intensive and conventional treatment arms were defined in the Cardiff Diabetes Model.
