Sentence examples for endpoints design from inspiring English sources

This chapter covers the basic concepts of clinical development including phases of development, study endpoints, design configurations, control groups, etc., as well as the content of the Clinical Development Plan.

In this article we also discuss our strategy of statistically correlating individual gene expression with biologically important endpoints designed to address the problem of evaluating functional relevance.

Improvements in trial design – such as enrollment of patients in the earliest detectable stages of clinical AD, selection of patients with confirmed Aβ pathology, rigorous evaluation of target engagement, and the use of endpoints designed to measure meaningful change – will allow more rigorous testing of the amyloid hypothesis in ongoing trials of amyloid-targeting agents8.

Although for certain therapeutic areas (most notably, psychiatric disorders) PROs may be included in clinical trials as primary efficacy indicators, commercial use of PRO outcomes focuses predominantly on their employment as secondary endpoints designed to provide 'added value' data to support key biomedical endpoints.

Aggarwal C, Borghaei H. Treatment paradigms for advanced non-small cell lung cancer at academic medical centers: involvement in clinical trial endpoint design.

FAST is a cardiovascular safety study using the prospective, randomised, open, blinded endpoint design.

The PROBE (prospective randomised open-blinded endpoint) design study was approved by the ethics committee of the state medical board.

SCOT is a large streamlined safety study conducted in Scotland, England, Denmark and the Netherlands using the Prospective Randomised Open Blinded Endpoint design.

Prospective, randomised, open, blinded endpoint design was applied for this study because blinding two different interventions was impossible in clinical setting.

While both advocate for a co-primary endpoint design using one cognitive and one functional (or global) endpoint, they also recognise that improvement on these endpoints alone could be a temporary, reversible effect that would not warrant a disease modification label for the drug.

The primary efficacy endpoint, designed to evaluate the efficacy of LDX vs placebo, was the total PERMP scale scores averaged over all postdose time points assessed in AWE classroom sessions during visits 5 and 6.