Primary Endpoint Results of the EVOLVE Trial

Effects of the Endpoint Adjudication Process on the Results of a Randomised Controlled Trial: The ADVANCE Trial

BACKGROUND Endpoint adjudication committees (EPAC) are widely used in clinical trials. The aim of the present analysis is to assess the effects of the endpoint adjudication process on the main findings of the ADVANCE trial (Trial registration: ClinicalTrials.gov NCT00145925). METHODS AND FINDINGS The ADVANCE trial was a multicentre, 2 × 2 factorial randomised controlled trial of blood pressur...

What can we learn from a statistically inconclusive trial? Consensus conference on the EVOLVE study results.

The link between serum parathyroid hormone (iPTH) and cardiovascular (CVS) mortality has not been fully elucidated. The EVOLVE Study was designed to test whether a drug such as cinacalcet, aimed at lowering iPTH, could reduce the astonishingly high cardiovascular risk in patients on maintenance dialysis (CKD-5D). Accordingly, the primary outcome of the study was the combined endpoint of time to...

Pediatric phase I trial design using maximum target inhibition as the primary endpoint.

The extent to which a drug inhibits a target responsible for a therapeutic effect is a more rational primary endpoint for dose-finding studies of more selective anticancer drugs than the conventional endpoint of dose-limiting toxicity (DLT) used for cytotoxic agents. An adaptive phase I trial design incorporating maximum target inhibition as the primary endpoint was developed to define the opti...

Platform to Select the Primary Endpoint in a Randomized Clinical Trial

We present CompARE, a web platform that computes how more efficient is to use a composite endpoint instead of one of its components. CompARE is based on the Asymptotic Relative Efficiency (ARE) method developed by Gómez and Lagakos. Users interact with CompARE through HTML form pages and no knowledge of R is needed. A list of candidate endpoints, anticipatable probabilities and hazard ratios ar...

Drug-eluting Coronary Stents: Primary Endpoint Results from the Dual Antiplatelet Therapy Study