Amy Rogers1, Robert Wv Flynn2, Patrick McDonnell2, Isla S Mackenzie2, Thomas M MacDonald2. 1. Medicines Monitoring Unit (MEMO) and Hypertension Research Centre, Division of Cardiovascular and Diabetes Medicine, University of Dundee, Ninewells Hospital and Medical School, Dundee, UK arogers@dundee.ac.uk. 2. Medicines Monitoring Unit (MEMO) and Hypertension Research Centre, Division of Cardiovascular and Diabetes Medicine, University of Dundee, Ninewells Hospital and Medical School, Dundee, UK.
Abstract
BACKGROUND: Trials of investigational medicinal products are required to adhere to strict guidelines with regard to the handling and supply of medication. Information technology offers opportunities to approach clinical trial methodology in new ways. This report summarises a novel pharmacy system designed to supply trial medications directly to patients by post in the Febuxostat versus Allopurinol Streamlined Trial. METHOD: A bespoke web-based software package was designed to facilitate the direct supply of trial medications to Febuxostat versus AllopurinolStreamlined Trial participants from a pharmacy based in the Medicines Monitoring Unit, University of Dundee. RESULTS: To date, 65,467 packs of medication have been dispensed using the system to 3978 patients. Up to 238 packs per day have been dispensed. CONCLUSION: The Medicines Monitoring Unit Febuxostat versus Allopurinol Streamlined Trial drug management system is an effective method of administering the complex drug supply requirements of a large-scale clinical trial with advantages over existing arrangements. A low rate of loss to follow-up in the Febuxostat versus Allopurinol Streamlined Trial may be attributable to the drug management system.
RCT Entities:
BACKGROUND: Trials of investigational medicinal products are required to adhere to strict guidelines with regard to the handling and supply of medication. Information technology offers opportunities to approach clinical trial methodology in new ways. This report summarises a novel pharmacy system designed to supply trial medications directly to patients by post in the Febuxostat versus Allopurinol Streamlined Trial. METHOD: A bespoke web-based software package was designed to facilitate the direct supply of trial medications to Febuxostat versus Allopurinol Streamlined Trial participants from a pharmacy based in the Medicines Monitoring Unit, University of Dundee. RESULTS: To date, 65,467 packs of medication have been dispensed using the system to 3978 patients. Up to 238 packs per day have been dispensed. CONCLUSION: The Medicines Monitoring Unit Febuxostat versus Allopurinol Streamlined Trial drug management system is an effective method of administering the complex drug supply requirements of a large-scale clinical trial with advantages over existing arrangements. A low rate of loss to follow-up in the Febuxostat versus Allopurinol Streamlined Trial may be attributable to the drug management system.
Authors: Nigel A Scott; Kara K Lee; Claire Sadowski; Ekaterina V Kurbatova; Stefan V Goldberg; Pheona Nsubuga; Rene Kitshoff; Colleen Whitelaw; Hanh Nguyen Thuy; Kumar Batra; Cynthia Allen-Blige; Howard Davis; Jay Kim; Mimi Phan; Pamela Fedrick; Kuo Wei Chiu; Charles M Heilig; Erin Sizemore Journal: Contemp Clin Trials Date: 2021-03-29 Impact factor: 2.261
Authors: Mauro Cortellini; Alice Casagrande; Giuseppe Fornaciari; Daniela Del Sette; Giuliana Gargano; Maria Gaetana Di Mauro; Gabriella Saibene; Eleonora Bruno; Anna Villarini; Elisabetta Venturelli; Franco Berrino; Ivan Baldassari; Andreina Oliverio; Patrizia Pasanisi Journal: PLoS One Date: 2019-02-22 Impact factor: 3.240