Cargando…
Concept and development of an interactive tool for trial recruitment planning and management
BACKGROUND: Predicting and monitoring recruitment in large, complex trials is essential to ensure appropriate resource management and budgeting. In a novel partnership between clinical trial investigators of the South African Medical Research Council and industrial engineers from the Stellenbosch Un...
Autores principales: | , , , |
---|---|
Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
BioMed Central
2021
|
Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7936448/ https://www.ncbi.nlm.nih.gov/pubmed/33676535 http://dx.doi.org/10.1186/s13063-021-05112-z |
_version_ | 1783661192601927680 |
---|---|
author | Spies, Ruan Siegfried, Nandi Myers, Bronwyn Grobbelaar, Sara S. |
author_facet | Spies, Ruan Siegfried, Nandi Myers, Bronwyn Grobbelaar, Sara S. |
author_sort | Spies, Ruan |
collection | PubMed |
description | BACKGROUND: Predicting and monitoring recruitment in large, complex trials is essential to ensure appropriate resource management and budgeting. In a novel partnership between clinical trial investigators of the South African Medical Research Council and industrial engineers from the Stellenbosch University Health Systems Engineering and Innovation Hub, we developed a trial recruitment tool (TRT). The objective of the tool is to serve as a computerised decisions-support system to aid the planning and management phases of the trial recruitment process. METHOD: The specific requirements of the TRT were determined in several workshops between the partners. A Poisson process simulation model was formulated and incorporated in the TRT to predict the recruitment duration. The assumptions underlying the model were made in consultation with the trial team at the start of the project and were deemed reasonable. Real-world data extracted from a current cluster trial, Project MIND, based in 24 sites in South Africa was used to verify the simulation model and to develop the monitoring component of the TRT. RESULTS: The TRT comprises a planning and monitoring component. The planning component generates different trial scenarios for predicted trial recruitment duration based on user inputs, e.g. number of sites, initiation delays. The monitoring component uses and analyses the data retrieved from the trial management information system to generate different levels of information, displayed visually on an interactive, user-friendly dashboard. Users can analyse the results at trial or site level, changing input parameters to see the resultant effect on the duration of trial recruitment. CONCLUSION: This TRT is an easy-to-use tool that assists in the management of the trial recruitment process. The TRT has potential to expedite improved management of clinical trials by providing the appropriate information needed for the planning and monitoring of the trial recruitment phase. This TRT extends prior tools describing historic recruitment only to using historic data to predict future recruitment. The broader project demonstrates the value of collaboration between clinicians and engineers to optimise their respective skillsets. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1186/s13063-021-05112-z. |
format | Online Article Text |
id | pubmed-7936448 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2021 |
publisher | BioMed Central |
record_format | MEDLINE/PubMed |
spelling | pubmed-79364482021-03-08 Concept and development of an interactive tool for trial recruitment planning and management Spies, Ruan Siegfried, Nandi Myers, Bronwyn Grobbelaar, Sara S. Trials Methodology BACKGROUND: Predicting and monitoring recruitment in large, complex trials is essential to ensure appropriate resource management and budgeting. In a novel partnership between clinical trial investigators of the South African Medical Research Council and industrial engineers from the Stellenbosch University Health Systems Engineering and Innovation Hub, we developed a trial recruitment tool (TRT). The objective of the tool is to serve as a computerised decisions-support system to aid the planning and management phases of the trial recruitment process. METHOD: The specific requirements of the TRT were determined in several workshops between the partners. A Poisson process simulation model was formulated and incorporated in the TRT to predict the recruitment duration. The assumptions underlying the model were made in consultation with the trial team at the start of the project and were deemed reasonable. Real-world data extracted from a current cluster trial, Project MIND, based in 24 sites in South Africa was used to verify the simulation model and to develop the monitoring component of the TRT. RESULTS: The TRT comprises a planning and monitoring component. The planning component generates different trial scenarios for predicted trial recruitment duration based on user inputs, e.g. number of sites, initiation delays. The monitoring component uses and analyses the data retrieved from the trial management information system to generate different levels of information, displayed visually on an interactive, user-friendly dashboard. Users can analyse the results at trial or site level, changing input parameters to see the resultant effect on the duration of trial recruitment. CONCLUSION: This TRT is an easy-to-use tool that assists in the management of the trial recruitment process. The TRT has potential to expedite improved management of clinical trials by providing the appropriate information needed for the planning and monitoring of the trial recruitment phase. This TRT extends prior tools describing historic recruitment only to using historic data to predict future recruitment. The broader project demonstrates the value of collaboration between clinicians and engineers to optimise their respective skillsets. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1186/s13063-021-05112-z. BioMed Central 2021-03-06 /pmc/articles/PMC7936448/ /pubmed/33676535 http://dx.doi.org/10.1186/s13063-021-05112-z Text en © The Author(s) 2021 Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated in a credit line to the data. |
spellingShingle | Methodology Spies, Ruan Siegfried, Nandi Myers, Bronwyn Grobbelaar, Sara S. Concept and development of an interactive tool for trial recruitment planning and management |
title | Concept and development of an interactive tool for trial recruitment planning and management |
title_full | Concept and development of an interactive tool for trial recruitment planning and management |
title_fullStr | Concept and development of an interactive tool for trial recruitment planning and management |
title_full_unstemmed | Concept and development of an interactive tool for trial recruitment planning and management |
title_short | Concept and development of an interactive tool for trial recruitment planning and management |
title_sort | concept and development of an interactive tool for trial recruitment planning and management |
topic | Methodology |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7936448/ https://www.ncbi.nlm.nih.gov/pubmed/33676535 http://dx.doi.org/10.1186/s13063-021-05112-z |
work_keys_str_mv | AT spiesruan conceptanddevelopmentofaninteractivetoolfortrialrecruitmentplanningandmanagement AT siegfriednandi conceptanddevelopmentofaninteractivetoolfortrialrecruitmentplanningandmanagement AT myersbronwyn conceptanddevelopmentofaninteractivetoolfortrialrecruitmentplanningandmanagement AT grobbelaarsaras conceptanddevelopmentofaninteractivetoolfortrialrecruitmentplanningandmanagement |