The Importance of Diversity and Inclusion in Drug Development and Clinical Trial Conduct

Moore, Kenneth Todd; Grundmann, Oliver; Iwuchukwu, Otito F.; Rakhmanina, Natella

doi:10.1002/jcph.2151

Cited by 3 publications

(1 citation statement)

References 13 publications

(71 reference statements)

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“…Food and Drug Administration white paper provide guidance around increasing clinical trial diversity in the drug development process, but all lack guidance specific to EPCTs. [10][11][12] EPCTs are conducted in healthy volunteers or participants with a specific health condition and help us understand the feasibility of the therapeutic approach, the appropriate dose of the new treatment, how the drug should be administered, how the body responds to the treatment and side-effects. More so, they hugely inform the design and conduct of related later-phase trials.…”

Section: Open Accessmentioning

confidence: 99%

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

Chatters,

Dimairo,

Cooper

et al. 2024

BMJ Open

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ObjectivesTo explore the importance of, and barriers to achieving, diversity in early-phase clinical trials.DesignQualitative interviews analysed using thematic analysis.Setting and participantsFive 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).ResultsProfessionals 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.ConclusionsDiversity 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.

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Section: Open Accessmentioning

confidence: 99%