دورية أكاديمية
أعرض في EDS

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

التفاصيل البيبلوغرافية
العنوان: A management system for randomized clinical trials: A novel way to supply medication.
المؤلفون: Cortellini M; Department of Preventive & Predictive Medicine, Epidemiology Unit, Foundation IRCCS National Cancer Institute of Milan, Milan, Italy.; Department of Nervous System and Behavioural Sciences, University of Pavia, Pavia, Italy., Casagrande A; Department of Preventive & Predictive Medicine, Epidemiology Unit, Foundation IRCCS National Cancer Institute of Milan, Milan, Italy., Fornaciari G; Department of Preventive & Predictive Medicine, Epidemiology Unit, Foundation IRCCS National Cancer Institute of Milan, Milan, Italy., Del Sette D; Department of Preventive & Predictive Medicine, Epidemiology Unit, Foundation IRCCS National Cancer Institute of Milan, Milan, Italy., Gargano G; Department of Preventive & Predictive Medicine, Epidemiology Unit, Foundation IRCCS National Cancer Institute of Milan, Milan, Italy., Di Mauro MG; Department of Preventive & Predictive Medicine, Epidemiology Unit, Foundation IRCCS National Cancer Institute of Milan, Milan, Italy., Saibene G; SC Pharmacy, Foundation IRCCS National Cancer Institute of Milan, Milan, Italy., Bruno E; Department of Preventive & Predictive Medicine, Epidemiology Unit, Foundation IRCCS National Cancer Institute of Milan, Milan, Italy.; Department of Biomedical Sciences for Health, University of Milan, Milan, Italy., Villarini A; Department of Preventive & Predictive Medicine, Epidemiology Unit, Foundation IRCCS National Cancer Institute of Milan, Milan, Italy., Venturelli E; Department of Preventive & Predictive Medicine, Epidemiology Unit, Foundation IRCCS National Cancer Institute of Milan, Milan, Italy., Berrino F; Department of Preventive & Predictive Medicine, Epidemiology Unit, Foundation IRCCS National Cancer Institute of Milan, Milan, Italy., Baldassari I; Department of Preventive & Predictive Medicine, Epidemiology Unit, Foundation IRCCS National Cancer Institute of Milan, Milan, Italy., Oliverio A; Department of Preventive & Predictive Medicine, Epidemiology Unit, Foundation IRCCS National Cancer Institute of Milan, Milan, Italy., Pasanisi P; Department of Preventive & Predictive Medicine, Epidemiology Unit, Foundation IRCCS National Cancer Institute of Milan, Milan, Italy.
المصدر: PloS one [PLoS One] 2019 Feb 22; Vol. 14 (2), pp. e0212475. Date of Electronic Publication: 2019 Feb 22 (Print Publication: 2019).
نوع المنشور: Journal Article; Research Support, Non-U.S. Gov't
اللغة: English
بيانات الدورية: Publisher: Public Library of Science Country of Publication: United States NLM ID: 101285081 Publication Model: eCollection Cited Medium: Internet ISSN: 1932-6203 (Electronic) Linking ISSN: 19326203 NLM ISO Abbreviation: PLoS One Subsets: MEDLINE
أسماء مطبوعة: Original Publication: San Francisco, CA : Public Library of Science
مواضيع طبية MeSH: Randomized Controlled Trials as Topic/*methods, Aged ; Clinical Trials, Phase III as Topic/methods ; Clinical Trials, Phase III as Topic/statistics & numerical data ; Female ; Humans ; Hypoglycemic Agents/therapeutic use ; Male ; Management Information Systems ; Medication Therapy Management ; Metabolic Syndrome/diet therapy ; Metabolic Syndrome/drug therapy ; Metformin/therapeutic use ; Middle Aged ; Randomized Controlled Trials as Topic/statistics & numerical data ; Software
مستخلص: 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 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 the handling and supply of medication.
Results: The trial is ongoing and recruitment will close on August 31, 2018. To date, 11737 bottles of metformin/placebo have been dispensed to 1054 randomized participants, with drug savings of 29.5%.
Conclusions: A software which takes into account the "state" of participant might be a powerful resource for developing and managing clinical trials, helping avoid poor treatment allocation, and wastage of drugs and money.
Me.me.me. Trial: EUDRACT no. 2012-005427-32. ClinicalTrials.gov Identifier: NCT02960711.
Competing Interests: The authors have declared that no competing interests exist.
References: Diabetes Obes Metab. 2011 Mar;13(3):221-8. (PMID: 21205121)
Oncogene. 2013 Mar 21;32(12):1475-87. (PMID: 22665053)
Cardiovasc Diabetol. 2015 Aug 14;14:109. (PMID: 26271457)
Contemp Clin Trials. 2007 May;28(3):329-36. (PMID: 17287151)
Am J Health Syst Pharm. 2008 May 15;65(10):969-73. (PMID: 18463347)
Diabetes Care. 2009 Sep;32(9):1620-5. (PMID: 19564453)
PLoS Med. 2008 Mar 4;5(3):e6. (PMID: 18318594)
Clin Breast Cancer. 2012 Jun;12(3):175-82. (PMID: 22607767)
Am J Hosp Pharm. 1992 Nov;49(11):2746-8. (PMID: 1471640)
J Nutr Biochem. 2007 Mar;18(3):149-60. (PMID: 16963247)
JAMA. 1995 Nov 8;274(18):1456-8. (PMID: 7474192)
Tumori. 2018 Mar-Apr;104(2):137-142. (PMID: 28106245)
Cell Cycle. 2009 Aug 15;8(16):2661. (PMID: 19571669)
BMJ. 2001 Aug 25;323(7310):446-7. (PMID: 11520850)
Lancet. 2014 Jan 11;383(9912):101-4. (PMID: 24411643)
Clin Trials. 2016 Dec;13(6):665-670. (PMID: 27371945)
سلسلة جزيئية: ClinicalTrials.gov NCT02960711
EudraCT 2012-005427-32
المشرفين على المادة: 0 (Hypoglycemic Agents)
9100L32L2N (Metformin)
تواريخ الأحداث: Date Created: 20190223 Date Completed: 20191118 Latest Revision: 20200309
رمز التحديث: 20231215
مُعرف محوري في PubMed: PMC6386477
DOI: 10.1371/journal.pone.0212475
PMID: 30794607
قاعدة البيانات: MEDLINE
الوصف
تدمد:1932-6203
DOI:10.1371/journal.pone.0212475