In most trials, only surrogate endpoints based on albuminuria were assessed, and, for several of the trials, hard endpoints for chronic kidney disease (doubling of serum creatinine concentration or end-stage renal disease) were not reported.
These studies will invariably necessitate consortium-driven biomarker trials with the most promising of these EMT surrogate endpoints to produce the most meaningful translational benefits.
Instead, most studies have considered surrogate endpoints [ 80].
In order to evaluate the clinical effectiveness of PD interventions, most clinical trials use surrogate endpoints or focus on PD symptoms severity, complications, or impact on patient HRQoL.
LDL reduction was chosen for sample size calculation because it is the most commonly used surrogate endpoint for cardiovascular disease reduction, and it is the primary target for statin therapy in cholesterol-lowering guidelines [ 4- 7].
The positive recommendations were largely based on surrogate endpoints, specifically PFS in most cases.
Most of these trials were small and used surrogate endpoints, such as biomarkers of pulmonary and systemic inflammation [ 6- 11].
In conclusion, although most trials were relatively short and focused on surrogate endpoints, liraglutide emerges as an effective and well tolerated treatment for type 2 diabetes, carrying a low risk of hypoglycemia, weight loss, and possible reduction of cardiovascular risk.
This was discussed at a recent international workshop on biomarkers as surrogate endpoints (Sydney Bio-Surrogates Workshop, February 2011, unpublished), and most workshop participants did not think it appropriate to calculate a confidence interval around a prediction interval.
Furthermore, most of the clinical trials funded by pharmaceutical companies are short-term, often use surrogate endpoints and are placebo controlled[ 41].
