Exploring reasons for recruitment failure in clinical trials: a qualitative study with clinical trial stakeholders in Switzerland, Germany, and Canada

Abstract Background Poor participant recruitment is the most frequent reason for premature discontinuation of randomized clinical trials (RCTs), particularly if they are investigator-initiated. The aims of this qualitative study were to investigate (1) the views of clinical trial stakeholders from t...

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Autores principales:	Matthias Briel, Bernice S. Elger, Stuart McLennan, Stefan Schandelmaier, Erik von Elm, Priya Satalkar
Formato:	article
Lenguaje:	EN
Publicado:	BMC 2021
Materias:	Randomized clinical trials Interview study Poor recruitment Reasons for recruitment failure Qualitative analysis Medicine (General) R5-920
Acceso en línea:	https://doaj.org/article/4eb4b19fbf2340dea3b7f8cb14f93eb8
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spelling	oai:doaj.org-article:4eb4b19fbf2340dea3b7f8cb14f93eb82021-11-28T12:28:39ZExploring reasons for recruitment failure in clinical trials: a qualitative study with clinical trial stakeholders in Switzerland, Germany, and Canada10.1186/s13063-021-05818-01745-6215https://doaj.org/article/4eb4b19fbf2340dea3b7f8cb14f93eb82021-11-01T00:00:00Zhttps://doi.org/10.1186/s13063-021-05818-0https://doaj.org/toc/1745-6215Abstract Background Poor participant recruitment is the most frequent reason for premature discontinuation of randomized clinical trials (RCTs), particularly if they are investigator-initiated. The aims of this qualitative study were to investigate (1) the views of clinical trial stakeholders from three different countries regarding reasons for recruitment failure in RCTs and (2) how these compare and contrast with the causes identified in a previous systematic review of RCT publications. Methods From August 2015 to November 2016, we conducted 49 semi-structured interviews with a purposive sample of clinical trial stakeholders. This included investigators based in Germany (n = 9), Switzerland (n = 6) and Canada (n = 1) with personal experience of a discontinued RCT and 33 other stakeholders (e.g., representatives of ethics committees, clinical trial units, pharmaceutical industry) in Switzerland. Individual semi-structured qualitative interviews were conducted and analyzed using thematic analysis. Results Interviewees identified a total of 29 different reasons for recruitment failure. Overoptimistic recruitment estimates, too narrow eligibility criteria, lack of engagement of recruiters/trial team, lack of competence/training/experience of recruiters, insufficient initial funding, and high burden for trial participants were mentioned most frequently. The interview findings largely confirm the previous systematic review on published reasons for recruitment failure. However, eight new reasons for recruitment failure were identified in the interviews, which led to the checklist of reasons for recruitment failure being revised and a new category describing research environment-related factors being added. Conclusions This study highlights the diversity of often interlinked reasons for recruitment failure in RCTs. Integrating the findings of this interview study with a previous systematic review of RCT publications led to a comprehensive, structured checklist of empirically-informed reasons for recruitment failure. The checklist may be useful to guide further research on interventions to improve participant recruitment in RCTs and helpful for trial investigators, research ethics committees, and funding agencies when assessing trial feasibility with respect to recruitment.Matthias BrielBernice S. ElgerStuart McLennanStefan SchandelmaierErik von ElmPriya SatalkarBMCarticleRandomized clinical trialsInterview studyPoor recruitmentReasons for recruitment failureQualitative analysisMedicine (General)R5-920ENTrials, Vol 22, Iss 1, Pp 1-13 (2021)
institution	DOAJ
collection	DOAJ
language	EN
topic	Randomized clinical trials Interview study Poor recruitment Reasons for recruitment failure Qualitative analysis Medicine (General) R5-920
spellingShingle	Randomized clinical trials Interview study Poor recruitment Reasons for recruitment failure Qualitative analysis Medicine (General) R5-920 Matthias Briel Bernice S. Elger Stuart McLennan Stefan Schandelmaier Erik von Elm Priya Satalkar Exploring reasons for recruitment failure in clinical trials: a qualitative study with clinical trial stakeholders in Switzerland, Germany, and Canada
description	Abstract Background Poor participant recruitment is the most frequent reason for premature discontinuation of randomized clinical trials (RCTs), particularly if they are investigator-initiated. The aims of this qualitative study were to investigate (1) the views of clinical trial stakeholders from three different countries regarding reasons for recruitment failure in RCTs and (2) how these compare and contrast with the causes identified in a previous systematic review of RCT publications. Methods From August 2015 to November 2016, we conducted 49 semi-structured interviews with a purposive sample of clinical trial stakeholders. This included investigators based in Germany (n = 9), Switzerland (n = 6) and Canada (n = 1) with personal experience of a discontinued RCT and 33 other stakeholders (e.g., representatives of ethics committees, clinical trial units, pharmaceutical industry) in Switzerland. Individual semi-structured qualitative interviews were conducted and analyzed using thematic analysis. Results Interviewees identified a total of 29 different reasons for recruitment failure. Overoptimistic recruitment estimates, too narrow eligibility criteria, lack of engagement of recruiters/trial team, lack of competence/training/experience of recruiters, insufficient initial funding, and high burden for trial participants were mentioned most frequently. The interview findings largely confirm the previous systematic review on published reasons for recruitment failure. However, eight new reasons for recruitment failure were identified in the interviews, which led to the checklist of reasons for recruitment failure being revised and a new category describing research environment-related factors being added. Conclusions This study highlights the diversity of often interlinked reasons for recruitment failure in RCTs. Integrating the findings of this interview study with a previous systematic review of RCT publications led to a comprehensive, structured checklist of empirically-informed reasons for recruitment failure. The checklist may be useful to guide further research on interventions to improve participant recruitment in RCTs and helpful for trial investigators, research ethics committees, and funding agencies when assessing trial feasibility with respect to recruitment.
format	article
author	Matthias Briel Bernice S. Elger Stuart McLennan Stefan Schandelmaier Erik von Elm Priya Satalkar
author_facet	Matthias Briel Bernice S. Elger Stuart McLennan Stefan Schandelmaier Erik von Elm Priya Satalkar
author_sort	Matthias Briel
title	Exploring reasons for recruitment failure in clinical trials: a qualitative study with clinical trial stakeholders in Switzerland, Germany, and Canada
title_short	Exploring reasons for recruitment failure in clinical trials: a qualitative study with clinical trial stakeholders in Switzerland, Germany, and Canada
title_full	Exploring reasons for recruitment failure in clinical trials: a qualitative study with clinical trial stakeholders in Switzerland, Germany, and Canada
title_fullStr	Exploring reasons for recruitment failure in clinical trials: a qualitative study with clinical trial stakeholders in Switzerland, Germany, and Canada
title_full_unstemmed	Exploring reasons for recruitment failure in clinical trials: a qualitative study with clinical trial stakeholders in Switzerland, Germany, and Canada
title_sort	exploring reasons for recruitment failure in clinical trials: a qualitative study with clinical trial stakeholders in switzerland, germany, and canada
publisher	BMC
publishDate	2021
url	https://doaj.org/article/4eb4b19fbf2340dea3b7f8cb14f93eb8
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Exploring reasons for recruitment failure in clinical trials: a qualitative study with clinical trial stakeholders in Switzerland, Germany, and Canada

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