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The challenges of long-term follow-up data collection in non-commercial, academically-led breast cancer clinical trials: the UK perspective

BACKGROUND: Improved survival rates in early breast cancer and the chronic nature of disease relapse result in a large cohort of patients being available for long-term follow-up (LTFUP) in randomised controlled trials. Whilst of recognised scientific value to assess long-term treatment-related seque...

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Autores principales: Kilburn, Lucy S, Banerji, Jane, Bliss, Judith M
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2014
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4192347/
https://www.ncbi.nlm.nih.gov/pubmed/25262026
http://dx.doi.org/10.1186/1745-6215-15-379
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author Kilburn, Lucy S
Banerji, Jane
Bliss, Judith M
author_facet Kilburn, Lucy S
Banerji, Jane
Bliss, Judith M
author_sort Kilburn, Lucy S
collection PubMed
description BACKGROUND: Improved survival rates in early breast cancer and the chronic nature of disease relapse result in a large cohort of patients being available for long-term follow-up (LTFUP) in randomised controlled trials. Whilst of recognised scientific value to assess long-term treatment-related sequelae, the volume of this activity can be challenging for trialists and participating sites, and comes at a considerable cost to research funders and the National Health Service (NHS). A National Cancer Research Institute Breast Clinical Studies Group supported project aimed to characterise UK LTFUP data collection procedures in order to propose improvements. METHODS: Protocols and case report forms for UK non-commercial National Institute for Health Research portfolio early breast cancer randomised controlled trials were reviewed and a questionnaire sent to associated participating NHS sites. Responders were asked to give opinions on issues with follow-up and LTFUP data collection procedures and to suggest potential improvements to practice. Results were used to inform design of a proposed standard LTFUP case report form. RESULTS: Thirty-four trials, involving eight Clinical Trials Units were eligible for inclusion in the review. All trials requested follow-up at least annually up to 5 years, with two-thirds requesting LTFUP after that time point. Information relating to efficacy endpoints was captured for all trials via case report forms; however, precise detail on recording of recurrence, second malignancies and death varied. Separately, questionnaires were returned from 66 NHS sites. Main concerns identified included difficulties in identifying all adverse events from hospital notes, volume of work, bureaucratic data management practices in Clinical Trials Units and perceptions of prioritisation of recruitment over follow-up. CONCLUSION: Variation has existed with respect to detail of LTFUP information requested for UK trials. Improved communication, simplification and standardisation of data and associated collection methods are possible without compromising data requirements for efficient and effective trial reporting. Future use of routinely collected data, captured via electronic means, could transform practices and alleviate resource usage. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (doi:10.1186/1745-6215-15-379) contains supplementary material, which is available to authorized users.
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spelling pubmed-41923472014-10-11 The challenges of long-term follow-up data collection in non-commercial, academically-led breast cancer clinical trials: the UK perspective Kilburn, Lucy S Banerji, Jane Bliss, Judith M Trials Research BACKGROUND: Improved survival rates in early breast cancer and the chronic nature of disease relapse result in a large cohort of patients being available for long-term follow-up (LTFUP) in randomised controlled trials. Whilst of recognised scientific value to assess long-term treatment-related sequelae, the volume of this activity can be challenging for trialists and participating sites, and comes at a considerable cost to research funders and the National Health Service (NHS). A National Cancer Research Institute Breast Clinical Studies Group supported project aimed to characterise UK LTFUP data collection procedures in order to propose improvements. METHODS: Protocols and case report forms for UK non-commercial National Institute for Health Research portfolio early breast cancer randomised controlled trials were reviewed and a questionnaire sent to associated participating NHS sites. Responders were asked to give opinions on issues with follow-up and LTFUP data collection procedures and to suggest potential improvements to practice. Results were used to inform design of a proposed standard LTFUP case report form. RESULTS: Thirty-four trials, involving eight Clinical Trials Units were eligible for inclusion in the review. All trials requested follow-up at least annually up to 5 years, with two-thirds requesting LTFUP after that time point. Information relating to efficacy endpoints was captured for all trials via case report forms; however, precise detail on recording of recurrence, second malignancies and death varied. Separately, questionnaires were returned from 66 NHS sites. Main concerns identified included difficulties in identifying all adverse events from hospital notes, volume of work, bureaucratic data management practices in Clinical Trials Units and perceptions of prioritisation of recruitment over follow-up. CONCLUSION: Variation has existed with respect to detail of LTFUP information requested for UK trials. Improved communication, simplification and standardisation of data and associated collection methods are possible without compromising data requirements for efficient and effective trial reporting. Future use of routinely collected data, captured via electronic means, could transform practices and alleviate resource usage. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (doi:10.1186/1745-6215-15-379) contains supplementary material, which is available to authorized users. BioMed Central 2014-09-27 /pmc/articles/PMC4192347/ /pubmed/25262026 http://dx.doi.org/10.1186/1745-6215-15-379 Text en © Kilburn et al.; licensee BioMed Central Ltd. 2014 This article is published under license to BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/4.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly credited. 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
Kilburn, Lucy S
Banerji, Jane
Bliss, Judith M
The challenges of long-term follow-up data collection in non-commercial, academically-led breast cancer clinical trials: the UK perspective
title The challenges of long-term follow-up data collection in non-commercial, academically-led breast cancer clinical trials: the UK perspective
title_full The challenges of long-term follow-up data collection in non-commercial, academically-led breast cancer clinical trials: the UK perspective
title_fullStr The challenges of long-term follow-up data collection in non-commercial, academically-led breast cancer clinical trials: the UK perspective
title_full_unstemmed The challenges of long-term follow-up data collection in non-commercial, academically-led breast cancer clinical trials: the UK perspective
title_short The challenges of long-term follow-up data collection in non-commercial, academically-led breast cancer clinical trials: the UK perspective
title_sort challenges of long-term follow-up data collection in non-commercial, academically-led breast cancer clinical trials: the uk perspective
topic Research
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4192347/
https://www.ncbi.nlm.nih.gov/pubmed/25262026
http://dx.doi.org/10.1186/1745-6215-15-379
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