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Clinical trial site identification practices and the use of electronic health records in feasibility evaluations: An interview study in the Nordic countries

INTRODUCTION: Feasibility evaluations are performed to create the best possible starting point for the set-up and execution of a clinical trial, and to identify any obstacles for successful trial conduct. New digital technologies can provide various types of data for use in feasibility evaluations....

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Autores principales: Laaksonen, Niina, Bengtström, Mia, Axelin, Anna, Blomster, Juuso, Scheinin, Mika, Huupponen, Risto
Formato: Online Artículo Texto
Lenguaje:English
Publicado: SAGE Publications 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8592101/
https://www.ncbi.nlm.nih.gov/pubmed/34431408
http://dx.doi.org/10.1177/17407745211038512
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author Laaksonen, Niina
Bengtström, Mia
Axelin, Anna
Blomster, Juuso
Scheinin, Mika
Huupponen, Risto
author_facet Laaksonen, Niina
Bengtström, Mia
Axelin, Anna
Blomster, Juuso
Scheinin, Mika
Huupponen, Risto
author_sort Laaksonen, Niina
collection PubMed
description INTRODUCTION: Feasibility evaluations are performed to create the best possible starting point for the set-up and execution of a clinical trial, and to identify any obstacles for successful trial conduct. New digital technologies can provide various types of data for use in feasibility evaluations. There is a need to identify and compare such data sources for trial site identification and for evaluating the sites’ patient recruitment potential. Especially, information is needed on the use of electronic health records. We investigated how different data sources are used by pharmaceutical companies operating in the Nordic countries for identifying trial sites and for evaluating their potential to recruit trial participants. METHODS: This was a semi-structured qualitative interview study with 21 participants from pharmaceutical companies and contract research organizations operating in Finland, Sweden, Denmark and Norway. Qualitative content analysis was applied. RESULTS: For identifying countries and trial sites on a global level, the trial sponsors mostly used databases on previous trial performance. The use of electronic health record data was very limited. Sites’ and investigators’ visibility in various databases was seen as fundamental for their countries becoming selected into new clinical trials. For estimating the sites’ recruitment projections, most sites were seen to base their patient count estimates solely on their previous experience. Some sites had reviewed their electronic health record data, which was considered to increase the accuracy of their recruitment estimates and these sites’ attractivity. Along with dialogs with investigators, the sponsors used various data sources to validate the investigators’ estimates. Legislative obstacles were seen to hinder the use of electronic health record queries for estimation of patient counts. CONCLUSION: Visibility in the databases used by trial sponsors is crucial for the countries and sites to be identified. Site selection appears to be based on trust and relationships built from experience, but electronic data provide the support upon which the trust is based. Estimation of the number of potential trial participants is a complex and time-consuming process for both investigators and sponsors. Sponsors seem to favour sites who could support their patient count estimates with electronic health record data as they were quicker in providing the estimates and more reliable than sites with no electronic health record evidence. The patient count evaluation process could be simplified, accelerated and made more reliable with more systematic use of electronic health record evidence in the feasibility evaluation phase. This would increase the accuracy of the patient count estimates and, on its part, contribute to improved recruitment success.
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spelling pubmed-85921012021-11-16 Clinical trial site identification practices and the use of electronic health records in feasibility evaluations: An interview study in the Nordic countries Laaksonen, Niina Bengtström, Mia Axelin, Anna Blomster, Juuso Scheinin, Mika Huupponen, Risto Clin Trials Recruitment and Retention INTRODUCTION: Feasibility evaluations are performed to create the best possible starting point for the set-up and execution of a clinical trial, and to identify any obstacles for successful trial conduct. New digital technologies can provide various types of data for use in feasibility evaluations. There is a need to identify and compare such data sources for trial site identification and for evaluating the sites’ patient recruitment potential. Especially, information is needed on the use of electronic health records. We investigated how different data sources are used by pharmaceutical companies operating in the Nordic countries for identifying trial sites and for evaluating their potential to recruit trial participants. METHODS: This was a semi-structured qualitative interview study with 21 participants from pharmaceutical companies and contract research organizations operating in Finland, Sweden, Denmark and Norway. Qualitative content analysis was applied. RESULTS: For identifying countries and trial sites on a global level, the trial sponsors mostly used databases on previous trial performance. The use of electronic health record data was very limited. Sites’ and investigators’ visibility in various databases was seen as fundamental for their countries becoming selected into new clinical trials. For estimating the sites’ recruitment projections, most sites were seen to base their patient count estimates solely on their previous experience. Some sites had reviewed their electronic health record data, which was considered to increase the accuracy of their recruitment estimates and these sites’ attractivity. Along with dialogs with investigators, the sponsors used various data sources to validate the investigators’ estimates. Legislative obstacles were seen to hinder the use of electronic health record queries for estimation of patient counts. CONCLUSION: Visibility in the databases used by trial sponsors is crucial for the countries and sites to be identified. Site selection appears to be based on trust and relationships built from experience, but electronic data provide the support upon which the trust is based. Estimation of the number of potential trial participants is a complex and time-consuming process for both investigators and sponsors. Sponsors seem to favour sites who could support their patient count estimates with electronic health record data as they were quicker in providing the estimates and more reliable than sites with no electronic health record evidence. The patient count evaluation process could be simplified, accelerated and made more reliable with more systematic use of electronic health record evidence in the feasibility evaluation phase. This would increase the accuracy of the patient count estimates and, on its part, contribute to improved recruitment success. SAGE Publications 2021-08-25 2021-12 /pmc/articles/PMC8592101/ /pubmed/34431408 http://dx.doi.org/10.1177/17407745211038512 Text en © The Author(s) 2021 https://creativecommons.org/licenses/by/4.0/This article is distributed under the terms of the Creative Commons Attribution 4.0 License (https://creativecommons.org/licenses/by/4.0/) which permits any use, reproduction and distribution of the work without further permission provided the original work is attributed as specified on the SAGE and Open Access pages (https://us.sagepub.com/en-us/nam/open-access-at-sage).
spellingShingle Recruitment and Retention
Laaksonen, Niina
Bengtström, Mia
Axelin, Anna
Blomster, Juuso
Scheinin, Mika
Huupponen, Risto
Clinical trial site identification practices and the use of electronic health records in feasibility evaluations: An interview study in the Nordic countries
title Clinical trial site identification practices and the use of electronic health records in feasibility evaluations: An interview study in the Nordic countries
title_full Clinical trial site identification practices and the use of electronic health records in feasibility evaluations: An interview study in the Nordic countries
title_fullStr Clinical trial site identification practices and the use of electronic health records in feasibility evaluations: An interview study in the Nordic countries
title_full_unstemmed Clinical trial site identification practices and the use of electronic health records in feasibility evaluations: An interview study in the Nordic countries
title_short Clinical trial site identification practices and the use of electronic health records in feasibility evaluations: An interview study in the Nordic countries
title_sort clinical trial site identification practices and the use of electronic health records in feasibility evaluations: an interview study in the nordic countries
topic Recruitment and Retention
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8592101/
https://www.ncbi.nlm.nih.gov/pubmed/34431408
http://dx.doi.org/10.1177/17407745211038512
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