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Lessons in participant retention in the course of a randomized controlled clinical trial

BACKGROUND: Clinical trials are increasingly being conducted as new products seek to enter the market. Deployment of such interventions is based on evidence obtained mainly from the gold standard of randomized controlled clinical trials (RCCT). A crucial factor in the ability of RCCTs to provide cre...

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Autores principales: Idoko, Olubukola T, Owolabi, Olumuyiwa A, Odutola, Aderonke A, Ogundare, Olatunde, Worwui, Archibald, Saidu, Yauba, Smith-Sanneh, Alison, Tunkara, Abdoulie, Sey, Gibbi, Sanyang, Assan, Mendy, Philip, Ota, Martin O C
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2014
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4200120/
https://www.ncbi.nlm.nih.gov/pubmed/25298043
http://dx.doi.org/10.1186/1756-0500-7-706
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author Idoko, Olubukola T
Owolabi, Olumuyiwa A
Odutola, Aderonke A
Ogundare, Olatunde
Worwui, Archibald
Saidu, Yauba
Smith-Sanneh, Alison
Tunkara, Abdoulie
Sey, Gibbi
Sanyang, Assan
Mendy, Philip
Ota, Martin O C
author_facet Idoko, Olubukola T
Owolabi, Olumuyiwa A
Odutola, Aderonke A
Ogundare, Olatunde
Worwui, Archibald
Saidu, Yauba
Smith-Sanneh, Alison
Tunkara, Abdoulie
Sey, Gibbi
Sanyang, Assan
Mendy, Philip
Ota, Martin O C
author_sort Idoko, Olubukola T
collection PubMed
description BACKGROUND: Clinical trials are increasingly being conducted as new products seek to enter the market. Deployment of such interventions is based on evidence obtained mainly from the gold standard of randomized controlled clinical trials (RCCT). A crucial factor in the ability of RCCTs to provide credible and generalisable data is sample size and retention of the required number of subjects at completion of the follow-up period. However, recruitment and retention in clinical trials are hindered by prevalent peculiar challenges in Africa that need to be circumvented. This article shares experiences from a phase II trial that recorded a high retention rate at 14 months follow-up at a new clinical trial site. METHODS: Mothers bringing children less than two months of age to the health facility were given information and invited to have their child enrolled if the inclusion criteria were fulfilled. Participants were enrolled over 8 months. Trial procedures, duration and risks/benefits were painstakingly and sequentially explained to the communities, parents and relevant relatives before and during the trial period. The proportions of participants that completed or did not complete the trial were analyzed including the reasons for failure to complete all trial procedures. RESULTS: 1044 individuals received information regarding the trial of which 371 returned for screening. 300 (81%) of them who fulfilled the inclusion criteria and did not meet any exclusion criteria were enrolled and 94% of these completed the trial. Consent withdrawal was the main reason for not completing the trial largely (75%) due to the father not being involved at the point of consenting or parents no longer being comfortable with blood sampling. CONCLUSIONS: Participant retention in clinical trials remains a crucial factor in ensuring generalisability of trial data. Appropriate measures to enhance retention should include continuous community involvement in the process, adequate explanation of trial procedures and risks/benefits; and innovative tracing of participants adapted for the setting.
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spelling pubmed-42001202014-10-18 Lessons in participant retention in the course of a randomized controlled clinical trial Idoko, Olubukola T Owolabi, Olumuyiwa A Odutola, Aderonke A Ogundare, Olatunde Worwui, Archibald Saidu, Yauba Smith-Sanneh, Alison Tunkara, Abdoulie Sey, Gibbi Sanyang, Assan Mendy, Philip Ota, Martin O C BMC Res Notes Research Article BACKGROUND: Clinical trials are increasingly being conducted as new products seek to enter the market. Deployment of such interventions is based on evidence obtained mainly from the gold standard of randomized controlled clinical trials (RCCT). A crucial factor in the ability of RCCTs to provide credible and generalisable data is sample size and retention of the required number of subjects at completion of the follow-up period. However, recruitment and retention in clinical trials are hindered by prevalent peculiar challenges in Africa that need to be circumvented. This article shares experiences from a phase II trial that recorded a high retention rate at 14 months follow-up at a new clinical trial site. METHODS: Mothers bringing children less than two months of age to the health facility were given information and invited to have their child enrolled if the inclusion criteria were fulfilled. Participants were enrolled over 8 months. Trial procedures, duration and risks/benefits were painstakingly and sequentially explained to the communities, parents and relevant relatives before and during the trial period. The proportions of participants that completed or did not complete the trial were analyzed including the reasons for failure to complete all trial procedures. RESULTS: 1044 individuals received information regarding the trial of which 371 returned for screening. 300 (81%) of them who fulfilled the inclusion criteria and did not meet any exclusion criteria were enrolled and 94% of these completed the trial. Consent withdrawal was the main reason for not completing the trial largely (75%) due to the father not being involved at the point of consenting or parents no longer being comfortable with blood sampling. CONCLUSIONS: Participant retention in clinical trials remains a crucial factor in ensuring generalisability of trial data. Appropriate measures to enhance retention should include continuous community involvement in the process, adequate explanation of trial procedures and risks/benefits; and innovative tracing of participants adapted for the setting. BioMed Central 2014-10-09 /pmc/articles/PMC4200120/ /pubmed/25298043 http://dx.doi.org/10.1186/1756-0500-7-706 Text en © Idoko 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/2.0), 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 Article
Idoko, Olubukola T
Owolabi, Olumuyiwa A
Odutola, Aderonke A
Ogundare, Olatunde
Worwui, Archibald
Saidu, Yauba
Smith-Sanneh, Alison
Tunkara, Abdoulie
Sey, Gibbi
Sanyang, Assan
Mendy, Philip
Ota, Martin O C
Lessons in participant retention in the course of a randomized controlled clinical trial
title Lessons in participant retention in the course of a randomized controlled clinical trial
title_full Lessons in participant retention in the course of a randomized controlled clinical trial
title_fullStr Lessons in participant retention in the course of a randomized controlled clinical trial
title_full_unstemmed Lessons in participant retention in the course of a randomized controlled clinical trial
title_short Lessons in participant retention in the course of a randomized controlled clinical trial
title_sort lessons in participant retention in the course of a randomized controlled clinical trial
topic Research Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4200120/
https://www.ncbi.nlm.nih.gov/pubmed/25298043
http://dx.doi.org/10.1186/1756-0500-7-706
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