Closeout of the HALT-PKD trials.

ABSTRACT:

Background

The HALT Polycystic Kidney Disease Trials Network consisted of two randomized, double blind, placebo-controlled trials among patients with autosomal dominant polycystic kidney disease. The trials involved 5-8years of participant follow-up with interventions in blood pressure and antihypertensive therapy. We provide a framework for designing and implementing closeout near the end of a trial while ensuring patient safety and maintaining scientific rigor and study morale.

Methods

We discuss issues and resolutions for determining the last visit, tapering medications, and unblinding of participants to study allocation and results. We also discuss closure of clinical sites and Data Coordinating Center responsibilities to ensure timely release of study results and meetin

SUBMITTER: Moore CG 

PROVIDER: S-EPMC4732941 | biostudies-literature | 2015 Sep

REPOSITORIES: biostudies-literature