Dataset Information

Optimizing drug inventory management with a web-based information system: The TBTC Study 31/ACTG A5349 experience.

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.

SUBMITTER: Scott NA

PROVIDER: S-EPMC9466280 | biostudies-literature | 2021 Jun

REPOSITORIES: biostudies-literature

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Publications

Optimizing drug inventory management with a web-based information system: The TBTC Study 31/ACTG A5349 experience.

Scott Nigel A NA Lee Kara K KK Sadowski Claire C Kurbatova Ekaterina V EV Goldberg Stefan V SV Nsubuga Pheona P Kitshoff Rene R Whitelaw Colleen C Thuy Hanh Nguyen HN Batra Kumar K Allen-Blige Cynthia C Davis Howard H Kim Jay J Phan Mimi M Fedrick Pamela P Chiu Kuo Wei KW Heilig Charles M CM Sizemore Erin E

Contemporary clinical trials 20210329

<h4>Introduction</h4>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 A ...[more]

PMID: 33794353

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Project description:BackgroundAn increasing number of research laboratories and core analytical facilities around the world are developing high throughput metabolomic analytical and data processing pipelines that are capable of handling hundreds to thousands of individual samples per year, often over multiple projects, collaborations and sample types. At present, there are no Laboratory Information Management Systems (LIMS) that are specifically tailored for metabolomics laboratories that are capable of tracking samples and associated metadata from the beginning to the end of an experiment, including data processing and archiving, and which are also suitable for use in large institutional core facilities or multi-laboratory consortia as well as single laboratory environments.ResultsHere we present MASTR-MS, a downloadable and installable LIMS solution that can be deployed either within a single laboratory or used to link workflows across a multisite network. It comprises a Node Management System that can be used to link and manage projects across one or multiple collaborating laboratories; a User Management System which defines different user groups and privileges of users; a Quote Management System where client quotes are managed; a Project Management System in which metadata is stored and all aspects of project management, including experimental setup, sample tracking and instrument analysis, are defined, and a Data Management System that allows the automatic capture and storage of raw and processed data from the analytical instruments to the LIMS.ConclusionMASTR-MS is a comprehensive LIMS solution specifically designed for metabolomics. It captures the entire lifecycle of a sample starting from project and experiment design to sample analysis, data capture and storage. It acts as an electronic notebook, facilitating project management within a single laboratory or a multi-node collaborative environment. This software is being developed in close consultation with members of the metabolomics research community. It is freely available under the GNU GPL v3 licence and can be accessed from, https://muccg.github.io/mastr-ms/.

Dataset Information

Optimizing drug inventory management with a web-based information system: The TBTC Study 31/ACTG A5349 experience.

Introduction

Material and methods

Results

Discussion

Trial registration

Publications

Optimizing drug inventory management with a web-based information system: The TBTC Study 31/ACTG A5349 experience.

Similar Datasets

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