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Learning from OCTET – exploring the acceptability of clinical trials management methods

BACKGROUND: Conducting research can be time consuming, difficult and challenging. Guidance and pragmatic advice focussing on randomised controlled trial conduct are available but do not necessarily constitute comprehensive guidance. A successful trial is one that recruits to time and target and coll...

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Autores principales: Arundel, Catherine, Gellatly, Judith
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2018
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6045834/
https://www.ncbi.nlm.nih.gov/pubmed/30005659
http://dx.doi.org/10.1186/s13063-018-2765-6
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author Arundel, Catherine
Gellatly, Judith
author_facet Arundel, Catherine
Gellatly, Judith
author_sort Arundel, Catherine
collection PubMed
description BACKGROUND: Conducting research can be time consuming, difficult and challenging. Guidance and pragmatic advice focussing on randomised controlled trial conduct are available but do not necessarily constitute comprehensive guidance. A successful trial is one that recruits to time and target and collects high-quality data within the originally agreed budget. Standardised trial management tools have outlined key project management elements for a successful trial as a method of ensuring good practice in research trials: initiation, planning, execution, monitoring and closure. Lessons are also frequently learnt during the development and conduct of trials but rarely shared for the benefit of others. For the wider research team, the key focus will always be on the execution and delivery of a study. The aim of this study was to evaluate the acceptability of clinical trials management methods, focussing on study execution and monitoring, as implemented in the National Institute for Health Research Health Technology Assessment Programme-funded Obsessive Compulsive Treatment Efficacy Trial (OCTET). METHODS: Workshops, questionnaires and semi-structured interviews were used to explore acceptability of trial management methods with members of the OCTET Trial research team. Nine members participated in the focus group, 10 completed a questionnaire and 20 were interviewed as part of qualitative work for the main OCTET study. Data was collected and analysed using thematic analysis. RESULTS: Six key themes were identified: support; communication; processes; resources; training and ethos. Clear and open communication, enthusiasm and accessibility of the trial managers and chief investigator were consistently noted as an important facet of the successful running of the trial. Clear resources and training materials were also found to be crucial in helping staff to work within the trial setting. Constructive suggestions were also made for improvement of these resources; for example, including both checklists and flowcharts within trial processes. CONCLUSION: Organisation, openness and positivity are crucial for executing a trial successfully, whilst clear and focussed processes and resources are essential in monitoring and controlling the trial progress. Although derived from a single study, these findings are likely to be applicable to the successful conduct of all trials. Trial managers should consider developing these elements when setting up a study. TRIAL REGISTRATION: Clinical Trial Registry, ID: ISRCTN73535163. Registered prospectively on 5 April 2011. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (10.1186/s13063-018-2765-6) contains supplementary material, which is available to authorized users.
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spelling pubmed-60458342018-07-16 Learning from OCTET – exploring the acceptability of clinical trials management methods Arundel, Catherine Gellatly, Judith Trials Research BACKGROUND: Conducting research can be time consuming, difficult and challenging. Guidance and pragmatic advice focussing on randomised controlled trial conduct are available but do not necessarily constitute comprehensive guidance. A successful trial is one that recruits to time and target and collects high-quality data within the originally agreed budget. Standardised trial management tools have outlined key project management elements for a successful trial as a method of ensuring good practice in research trials: initiation, planning, execution, monitoring and closure. Lessons are also frequently learnt during the development and conduct of trials but rarely shared for the benefit of others. For the wider research team, the key focus will always be on the execution and delivery of a study. The aim of this study was to evaluate the acceptability of clinical trials management methods, focussing on study execution and monitoring, as implemented in the National Institute for Health Research Health Technology Assessment Programme-funded Obsessive Compulsive Treatment Efficacy Trial (OCTET). METHODS: Workshops, questionnaires and semi-structured interviews were used to explore acceptability of trial management methods with members of the OCTET Trial research team. Nine members participated in the focus group, 10 completed a questionnaire and 20 were interviewed as part of qualitative work for the main OCTET study. Data was collected and analysed using thematic analysis. RESULTS: Six key themes were identified: support; communication; processes; resources; training and ethos. Clear and open communication, enthusiasm and accessibility of the trial managers and chief investigator were consistently noted as an important facet of the successful running of the trial. Clear resources and training materials were also found to be crucial in helping staff to work within the trial setting. Constructive suggestions were also made for improvement of these resources; for example, including both checklists and flowcharts within trial processes. CONCLUSION: Organisation, openness and positivity are crucial for executing a trial successfully, whilst clear and focussed processes and resources are essential in monitoring and controlling the trial progress. Although derived from a single study, these findings are likely to be applicable to the successful conduct of all trials. Trial managers should consider developing these elements when setting up a study. TRIAL REGISTRATION: Clinical Trial Registry, ID: ISRCTN73535163. Registered prospectively on 5 April 2011. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (10.1186/s13063-018-2765-6) contains supplementary material, which is available to authorized users. BioMed Central 2018-07-13 /pmc/articles/PMC6045834/ /pubmed/30005659 http://dx.doi.org/10.1186/s13063-018-2765-6 Text en © The Author(s). 2018 Open Access This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. 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.
spellingShingle Research
Arundel, Catherine
Gellatly, Judith
Learning from OCTET – exploring the acceptability of clinical trials management methods
title Learning from OCTET – exploring the acceptability of clinical trials management methods
title_full Learning from OCTET – exploring the acceptability of clinical trials management methods
title_fullStr Learning from OCTET – exploring the acceptability of clinical trials management methods
title_full_unstemmed Learning from OCTET – exploring the acceptability of clinical trials management methods
title_short Learning from OCTET – exploring the acceptability of clinical trials management methods
title_sort learning from octet – exploring the acceptability of clinical trials management methods
topic Research
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6045834/
https://www.ncbi.nlm.nih.gov/pubmed/30005659
http://dx.doi.org/10.1186/s13063-018-2765-6
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