Clinical trial recruiters’ experiences working with trial eligibility criteria: results of an exploratory, cross-sectional, online survey in the UK
Abstract Background Eligibility criteria are a fundamental element of clinical trial design, defining who can and who should not participate in a trial. Problems with the design or application of criteria are known to occur and pose risks to participants’ safety and trial integrity, sometimes also n...
| Main Authors: | , , , , , |
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| Format: | Article |
| Language: | English |
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BMC
2021-10-01
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| Series: | Trials |
| Subjects: | |
| Online Access: | https://doi.org/10.1186/s13063-021-05723-6 |
| _version_ | 1818741601372995584 |
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| author | William J. Cragg Kathryn McMahon Jamie B. Oughton Rachel Sigsworth Christopher Taylor Vicky Napp |
| author_facet | William J. Cragg Kathryn McMahon Jamie B. Oughton Rachel Sigsworth Christopher Taylor Vicky Napp |
| author_sort | William J. Cragg |
| collection | DOAJ |
| description | Abstract Background Eligibility criteria are a fundamental element of clinical trial design, defining who can and who should not participate in a trial. Problems with the design or application of criteria are known to occur and pose risks to participants’ safety and trial integrity, sometimes also negatively impacting on trial recruitment and generalisability. We conducted a short, exploratory survey to gather evidence on UK recruiters’ experiences interpreting and applying eligibility criteria and their views on how criteria are communicated and developed. Methods Our survey included topics informed by a wider programme of work at the Clinical Trials Research Unit, University of Leeds, on assuring eligibility criteria quality. Respondents were asked to answer based on all their trial experience, not only on experiences with our trials. The survey was disseminated to recruiters collaborating on trials run at our trials unit, and via other mailing lists and social media. The quantitative responses were descriptively analysed, with inductive analysis of free-text responses to identify themes. Results A total of 823 eligible respondents participated. In total, 79% of respondents reported finding problems with eligibility criteria in some trials, and 9% in most trials. The main themes in the types of problems experienced were criteria clarity (67% of comments), feasibility (34%), and suitability (14%). In total, 27% of those reporting some level of problem said these problems had led to patients being incorrectly included in trials; 40% said they had led to incorrect exclusions. Most respondents (56%) reported accessing eligibility criteria mainly in the trial protocol. Most respondents (74%) supported the idea of recruiter review of eligibility criteria earlier in the protocol development process. Conclusions Our survey corroborates other evidence about the existence of suboptimal trial eligibility criteria. Problems with clarity were the most often reported, but the number of comments on feasibility and suitability suggest some recruiters feel eligibility criteria and associated assessments can hinder recruitment to trials. Our proposal for more recruiter involvement in protocol development has strong support and some potential benefits, but questions remain about how best to implement this. We invite other trialists to consider our other suggestions for how to assure quality in trial eligibility criteria. |
| first_indexed | 2024-12-18T01:59:13Z |
| format | Article |
| id | doaj.art-15a8cdf427974bc28423cc1635524e6f |
| institution | Directory Open Access Journal |
| issn | 1745-6215 |
| language | English |
| last_indexed | 2024-12-18T01:59:13Z |
| publishDate | 2021-10-01 |
| publisher | BMC |
| record_format | Article |
| series | Trials |
| spelling | doaj.art-15a8cdf427974bc28423cc1635524e6f2022-12-21T21:24:49ZengBMCTrials1745-62152021-10-0122111210.1186/s13063-021-05723-6Clinical trial recruiters’ experiences working with trial eligibility criteria: results of an exploratory, cross-sectional, online survey in the UKWilliam J. Cragg0Kathryn McMahon1Jamie B. Oughton2Rachel Sigsworth3Christopher Taylor4Vicky Napp5Clinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of LeedsClinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of LeedsClinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of LeedsClinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of LeedsClinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of LeedsClinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of LeedsAbstract Background Eligibility criteria are a fundamental element of clinical trial design, defining who can and who should not participate in a trial. Problems with the design or application of criteria are known to occur and pose risks to participants’ safety and trial integrity, sometimes also negatively impacting on trial recruitment and generalisability. We conducted a short, exploratory survey to gather evidence on UK recruiters’ experiences interpreting and applying eligibility criteria and their views on how criteria are communicated and developed. Methods Our survey included topics informed by a wider programme of work at the Clinical Trials Research Unit, University of Leeds, on assuring eligibility criteria quality. Respondents were asked to answer based on all their trial experience, not only on experiences with our trials. The survey was disseminated to recruiters collaborating on trials run at our trials unit, and via other mailing lists and social media. The quantitative responses were descriptively analysed, with inductive analysis of free-text responses to identify themes. Results A total of 823 eligible respondents participated. In total, 79% of respondents reported finding problems with eligibility criteria in some trials, and 9% in most trials. The main themes in the types of problems experienced were criteria clarity (67% of comments), feasibility (34%), and suitability (14%). In total, 27% of those reporting some level of problem said these problems had led to patients being incorrectly included in trials; 40% said they had led to incorrect exclusions. Most respondents (56%) reported accessing eligibility criteria mainly in the trial protocol. Most respondents (74%) supported the idea of recruiter review of eligibility criteria earlier in the protocol development process. Conclusions Our survey corroborates other evidence about the existence of suboptimal trial eligibility criteria. Problems with clarity were the most often reported, but the number of comments on feasibility and suitability suggest some recruiters feel eligibility criteria and associated assessments can hinder recruitment to trials. Our proposal for more recruiter involvement in protocol development has strong support and some potential benefits, but questions remain about how best to implement this. We invite other trialists to consider our other suggestions for how to assure quality in trial eligibility criteria.https://doi.org/10.1186/s13063-021-05723-6Eligibility criteriaInclusion criteriaExclusion criteriaRecruitmentProtocol developmentGeneralisability |
| spellingShingle | William J. Cragg Kathryn McMahon Jamie B. Oughton Rachel Sigsworth Christopher Taylor Vicky Napp Clinical trial recruiters’ experiences working with trial eligibility criteria: results of an exploratory, cross-sectional, online survey in the UK Trials Eligibility criteria Inclusion criteria Exclusion criteria Recruitment Protocol development Generalisability |
| title | Clinical trial recruiters’ experiences working with trial eligibility criteria: results of an exploratory, cross-sectional, online survey in the UK |
| title_full | Clinical trial recruiters’ experiences working with trial eligibility criteria: results of an exploratory, cross-sectional, online survey in the UK |
| title_fullStr | Clinical trial recruiters’ experiences working with trial eligibility criteria: results of an exploratory, cross-sectional, online survey in the UK |
| title_full_unstemmed | Clinical trial recruiters’ experiences working with trial eligibility criteria: results of an exploratory, cross-sectional, online survey in the UK |
| title_short | Clinical trial recruiters’ experiences working with trial eligibility criteria: results of an exploratory, cross-sectional, online survey in the UK |
| title_sort | clinical trial recruiters experiences working with trial eligibility criteria results of an exploratory cross sectional online survey in the uk |
| topic | Eligibility criteria Inclusion criteria Exclusion criteria Recruitment Protocol development Generalisability |
| url | https://doi.org/10.1186/s13063-021-05723-6 |
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