Exploring the barriers to, and importance of, participant diversity in early-phase clinical trials: an interview-based qualitative study of professionals and patient and public representatives
Objectives To explore the importance of, and barriers to achieving, diversity in early-phase clinical trials.Design Qualitative interviews analysed using thematic analysis.Setting and participants Five professionals (clinical researchers and methodologists) and three patient and public representativ...
| Main Authors: | , , , , , , , , , |
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| Format: | Article |
| Language: | English |
| Published: |
BMJ Publishing Group
2024-03-01
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| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/14/3/e075547.full |
| _version_ | 1797256275092832256 |
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| author | Cindy Cooper Katie Biggs Alexander Rothman Christina Yap Fiona Thistlethwaite Della Ogunleye Munyaradzi Dimairo Robin Chatters Shamila Ditta Jonathan Woodward |
| author_facet | Cindy Cooper Katie Biggs Alexander Rothman Christina Yap Fiona Thistlethwaite Della Ogunleye Munyaradzi Dimairo Robin Chatters Shamila Ditta Jonathan Woodward |
| author_sort | Cindy Cooper |
| collection | DOAJ |
| description | Objectives To explore the importance of, and barriers to achieving, diversity in early-phase clinical trials.Design Qualitative interviews analysed using thematic analysis.Setting and participants Five professionals (clinical researchers and methodologists) and three patient and public representatives (those with experience of early-phase clinical trials and/or those from ethnic minority backgrounds) were interviewed between June and August 2022. Participants were identified via their institutional web page, existing contacts or social media (eg, X, formerly known as Twitter).Results Professionals viewed that diversity is not currently considered in all early-phase clinical trials but felt that it should always be taken into account. Such trials are primarily undertaken at a small number of centres, thus limiting the populations they can access. Referrals from clinicians based in the community may increase diversity; however, those referred are often not from underserved groups. Referrals may be hindered by the extra resources required to approach and recruit underserved groups and participants often having to undertake ‘self-driven’ referrals. Patient and public representatives stated that diversity is important in research staff and that potential participants should be informed of the need for diversity. Those from underserved groups may require clarification regarding the potential harms of a treatment, even if these are unknown. Education may improve awareness and perception of early-phase clinical trials. We provide 14 recommendations to improve diversity in early-phase clinical trials.Conclusions Diversity should be considered in all early-phase trials. Consideration is required regarding the extent of diversity and how it is addressed. The increased resources needed to recruit those from underserved groups may warrant funders to increase the funds to support the recruitment of such participants. The potential harms and societal benefits of the research should be presented to potential participants in a balanced but accurate way to increase transparency. |
| first_indexed | 2024-04-24T22:19:09Z |
| format | Article |
| id | doaj.art-674fc1be3ed945029b5589455bc890a0 |
| institution | Directory Open Access Journal |
| issn | 2044-6055 |
| language | English |
| last_indexed | 2024-04-24T22:19:09Z |
| publishDate | 2024-03-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Open |
| spelling | doaj.art-674fc1be3ed945029b5589455bc890a02024-03-20T06:15:08ZengBMJ Publishing GroupBMJ Open2044-60552024-03-0114310.1136/bmjopen-2023-075547Exploring the barriers to, and importance of, participant diversity in early-phase clinical trials: an interview-based qualitative study of professionals and patient and public representativesCindy Cooper0Katie Biggs1Alexander Rothman2Christina Yap3Fiona Thistlethwaite4Della Ogunleye5Munyaradzi Dimairo6Robin Chatters7Shamila Ditta8Jonathan Woodward9Sheffield Clinical Trials Research Unit (CTRU), Sheffield Centre for Health and Related Research, The University of Sheffield, Sheffield, UKClinical Trials Research Unit (CTRU), Health Services Research School of Health and Related Research (ScHARR), The University of Sheffield, Sheffield, UK1Department of Infection, Immunity and Cardiovascular disease, University of Sheffield, Sheffield, UKClinical Trials and Statistics Unit, The Institute of Cancer Research, Sutton, UKThe Christie Hospital NHS Foundation Trust and University of Manchester, Manchester, UK3 Department of Practice and Policy, UCL School of Pharmacy, London, UKClinical Trials Research Unit, School of Health and Related Research, The University of Sheffield, Sheffield, UKClinical Trials Research Unit, School of Health and Related Research, The University of Sheffield, Sheffield, UKSheffield Clinical Trials Research Unit (CTRU), Sheffield Centre for Health and Related Research, The University of Sheffield, Sheffield, UKSheffield Clinical Trials Research Unit (CTRU), Sheffield Centre for Health and Related Research, The University of Sheffield, Sheffield, UKObjectives To explore the importance of, and barriers to achieving, diversity in early-phase clinical trials.Design Qualitative interviews analysed using thematic analysis.Setting and participants Five professionals (clinical researchers and methodologists) and three patient and public representatives (those with experience of early-phase clinical trials and/or those from ethnic minority backgrounds) were interviewed between June and August 2022. Participants were identified via their institutional web page, existing contacts or social media (eg, X, formerly known as Twitter).Results Professionals viewed that diversity is not currently considered in all early-phase clinical trials but felt that it should always be taken into account. Such trials are primarily undertaken at a small number of centres, thus limiting the populations they can access. Referrals from clinicians based in the community may increase diversity; however, those referred are often not from underserved groups. Referrals may be hindered by the extra resources required to approach and recruit underserved groups and participants often having to undertake ‘self-driven’ referrals. Patient and public representatives stated that diversity is important in research staff and that potential participants should be informed of the need for diversity. Those from underserved groups may require clarification regarding the potential harms of a treatment, even if these are unknown. Education may improve awareness and perception of early-phase clinical trials. We provide 14 recommendations to improve diversity in early-phase clinical trials.Conclusions Diversity should be considered in all early-phase trials. Consideration is required regarding the extent of diversity and how it is addressed. The increased resources needed to recruit those from underserved groups may warrant funders to increase the funds to support the recruitment of such participants. The potential harms and societal benefits of the research should be presented to potential participants in a balanced but accurate way to increase transparency.https://bmjopen.bmj.com/content/14/3/e075547.full |
| spellingShingle | Cindy Cooper Katie Biggs Alexander Rothman Christina Yap Fiona Thistlethwaite Della Ogunleye Munyaradzi Dimairo Robin Chatters Shamila Ditta Jonathan Woodward Exploring the barriers to, and importance of, participant diversity in early-phase clinical trials: an interview-based qualitative study of professionals and patient and public representatives BMJ Open |
| title | Exploring the barriers to, and importance of, participant diversity in early-phase clinical trials: an interview-based qualitative study of professionals and patient and public representatives |
| title_full | Exploring the barriers to, and importance of, participant diversity in early-phase clinical trials: an interview-based qualitative study of professionals and patient and public representatives |
| title_fullStr | Exploring the barriers to, and importance of, participant diversity in early-phase clinical trials: an interview-based qualitative study of professionals and patient and public representatives |
| title_full_unstemmed | Exploring the barriers to, and importance of, participant diversity in early-phase clinical trials: an interview-based qualitative study of professionals and patient and public representatives |
| title_short | Exploring the barriers to, and importance of, participant diversity in early-phase clinical trials: an interview-based qualitative study of professionals and patient and public representatives |
| title_sort | exploring the barriers to and importance of participant diversity in early phase clinical trials an interview based qualitative study of professionals and patient and public representatives |
| url | https://bmjopen.bmj.com/content/14/3/e075547.full |
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