Nigel A Scott1, Kara K Lee2, Claire Sadowski3, Ekaterina V Kurbatova2, Stefan V Goldberg2, Pheona Nsubuga4, Rene Kitshoff5, Colleen Whitelaw6, Hanh Nguyen Thuy7, Kumar Batra8, Cynthia Allen-Blige8, Howard Davis8, Jay Kim8, Mimi Phan9, Pamela Fedrick8, Kuo Wei Chiu9, Charles M Heilig2, Erin Sizemore2. 1. U.S. Centers for Disease Control & Prevention, Atlanta, GA, USA. Electronic address: NScott@cdc.gov. 2. U.S. Centers for Disease Control & Prevention, Atlanta, GA, USA. 3. U.S. Centers for Disease Control & Prevention, Atlanta, GA, USA; Oak Ridge Institute for Science and Education, Oak Ridge, TN, USA. 4. Uganda - Case Western Reserve University Research Collaboration, Kampala, Uganda. 5. TASK Applied Science CRS, Stellenbosch, South Africa. 6. University of Cape Town Lung Institute (Pty) Ltd (UCTLI), Centre for Tuberculosis Research Innovation (CTBRI), Cape Town, South Africa. 7. Vietnam National Tuberculosis Program/University of California San Francisco Research Collaboration, Hanoi, Viet Nam. 8. Peraton Corporation, Herndon, VA, USA. 9. Northrop Grumman Corporation, San Diego, CA, USA.
Abstract
INTRODUCTION: Efficient management of study drug inventory shipments is critical to keep research sites enrolling into multisite clinical treatment trials. A standard manual drug-management process used by the Tuberculosis Trials Consortium (TBTC), did not accommodate import permit approval timelines, shipment transit-times and time-zone differences. We compared a new web-based solution with the manual process, during an international 34-site clinical trial conducted by the TBTC and the AIDS Clinical Trials Group (ACTG); TBTC Study 31/ACTG A5349. MATERIAL AND METHODS: We developed and implemented a technological solution by integrating logistical and regulatory requirements for drug importation with statistical simulations that estimated stock-out times in an online Drug Management Module (DMM). We measured the average shipment-related drug stock-outs and time to drug availability, to assess the efficiency of the DMM compared to the manual approach. RESULTS: An Interrupted Time-Series (ITS) analysis showed a 15.4% [p-value = 0.03; 95% C.I. (-28.8%, -2.0%)] reduction in average shipment-related study drug stock-out after DMM implementation. The DMM streamlined the restocking process at study sites, reducing median transit-time for sites associated with a depot by 2 days [95% C.I. (-3.0, -1.0)]. Under the DMM, study drugs were available for treatment assignment on the day received, compared to one day after receipt under the manual process. DISCUSSION: The DMM provided TBTC's Data and Coordinating Center and site staff with more efficient procedures to manage and consistently maintain study drug inventory at enrolling sites. This DMM framework can improve efficiency in future multicenter clinical trials. TRIAL REGISTRATION: This trial was registered with ClinicalTrials.gov (Identifier: NCT02410772) on April 8, 2015. Published by Elsevier Inc.
INTRODUCTION: Efficient management of study drug inventory shipments is critical to keep research sites enrolling into multisite clinical treatment trials. A standard manual drug-management process used by the Tuberculosis Trials Consortium (TBTC), did not accommodate import permit approval timelines, shipment transit-times and time-zone differences. We compared a new web-based solution with the manual process, during an international 34-site clinical trial conducted by the TBTC and the AIDS Clinical Trials Group (ACTG); TBTC Study 31/ACTG A5349. MATERIAL AND METHODS: We developed and implemented a technological solution by integrating logistical and regulatory requirements for drug importation with statistical simulations that estimated stock-out times in an online Drug Management Module (DMM). We measured the average shipment-related drug stock-outs and time to drug availability, to assess the efficiency of the DMM compared to the manual approach. RESULTS: An Interrupted Time-Series (ITS) analysis showed a 15.4% [p-value = 0.03; 95% C.I. (-28.8%, -2.0%)] reduction in average shipment-related study drug stock-out after DMM implementation. The DMM streamlined the restocking process at study sites, reducing median transit-time for sites associated with a depot by 2 days [95% C.I. (-3.0, -1.0)]. Under the DMM, study drugs were available for treatment assignment on the day received, compared to one day after receipt under the manual process. DISCUSSION: The DMM provided TBTC's Data and Coordinating Center and site staff with more efficient procedures to manage and consistently maintain study drug inventory at enrolling sites. This DMM framework can improve efficiency in future multicenter clinical trials. TRIAL REGISTRATION: This trial was registered with ClinicalTrials.gov (Identifier: NCT02410772) on April 8, 2015. Published by Elsevier Inc.
Entities:
Keywords:
Interrupted time-series analysis; Statistical simulations; Study drug inventory management; Study drug stock-out; Trial pharmaceuticals; Web-based system
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