A management system for randomized clinical trials: A novel way to supply medication.

ABSTRACT:

Background

Randomized controlled clinical trials require management effort, involving huge organizational, economic and informatics investments. Information technology offers opportunities to approach clinical trial methodology in new ways. However, there are only a few reports of computerized data and drug management systems.

Objective

This paper describes a novel software created specifically for the management of a randomized trial of diet and metformin in people with metabolic syndrome (the Me.Me.Me. trial).

Methods

Me.Me.Me. is an ongoing phase III randomized controlled trial in healthy people with metabolic syndrome to test the hypothesis that comprehensive lifestyle changes and/or metformin can prevent age-related chronic non-communicable diseases. To manage al

SUBMITTER: Cortellini M 

PROVIDER: S-EPMC6386477 | biostudies-literature | 2019

REPOSITORIES: biostudies-literature