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

PloS One
Mauro CortelliniPatrizia Pasanisi

Abstract

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. 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). 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 all the phases of the trial, we created a software which is a state pattern machine, user friendly, web-based, able to maintain the correct balance between randomization groups, and structured in various levels of security in order to guarantee the participant's privacy and compliance with the study protocol. The software achieves budget savings: drug management is not based on patients' packs, but on the actual need for drugs according to each participant's "state", with strict guidelines for t...Continue Reading

References

Nov 8, 1995·JAMA : the Journal of the American Medical Association·K F Schulz
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Sep 12, 2006·The Journal of Nutritional Biochemistry·Helmut Schröder
Feb 9, 2007·Contemporary Clinical Trials·James A Welker
May 9, 2008·American Journal of Health-system Pharmacy : AJHP : Official Journal of the American Society of Health-System Pharmacists·Burgunda V SweetRoberta M Tankanow
Jul 3, 2009·Cell Cycle·Paola MutiGiovanni Blandino
Jan 15, 2014·Lancet·Malcolm R MacleodPaul Glasziou
Aug 15, 2015·Cardiovascular Diabetology·Daniel I Bromage, Derek M Yellon

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OPENSPECIMEN
CTMS
ARUBA Spa
IVRS
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SDMS
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Cisco
REDCap
Medidata Rave

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