Abstract
Objective: The objective of this study was to investigate the use of recruitment and retention strategies to promote the inclusion of historically marginalized groups in Chronic Kidney Disease (CKD) clinical trials.
Background: CKD affects roughly 15% of the adults in the United States. CKD and its progression to ESRD are associated with a high mortality rate and have been known to disproportionately affect historically marginalized groups. Clinical trials are necessary for developing effective therapies for treating CKD, however, participants in these trials do not accurately reflect the CKD disease population. To improve representation, recruitment and retention strategies must be implemented.
Methods: We performed a cross-sectional analysis of CKD clinical trials published from 2018 to 2023. Relevant CKD articles were obtained using the Cochrane Database of Systematic Reviews, MEDLINE (PubMed), and Embase (Elsevier). Studies were included if they were: relevant to CKD, assessed the effects of an intervention, and conducted in a country with an Ethnic Fractionalization Index (EFI) of greater than or equal to 0.3 or a composite EFI of 0.3.
Results: Of the initial 306 studies associated with CKD, 52 met all eligibility criteria for extraction in this study. Results from our systematic review showed only 6 trials mentioned recruitment strategies for historically marginalized groups, 11 mentioned a planned diversity goal, and just 3 reported any retention strategies. Additionally, only 5 studies listed limitations related to recruitment.
Conclusion: Our analysis highlights significant gaps in the recruitment and retention of participants from historically marginalized groups in CKD clinical trials. While U.S.-based studies show greater inclusivity efforts, overall strategies remain inadequate. Addressing these deficiencies requires targeted policies, evidence-based site selection, and inclusive recruitment practices. Future research should focus on broadening eligibility criteria and implementing validated strategies to enhance diversity, ultimately improving the generalizability and influence of CKD clinical trial outcomes.
Background: CKD affects roughly 15% of the adults in the United States. CKD and its progression to ESRD are associated with a high mortality rate and have been known to disproportionately affect historically marginalized groups. Clinical trials are necessary for developing effective therapies for treating CKD, however, participants in these trials do not accurately reflect the CKD disease population. To improve representation, recruitment and retention strategies must be implemented.
Methods: We performed a cross-sectional analysis of CKD clinical trials published from 2018 to 2023. Relevant CKD articles were obtained using the Cochrane Database of Systematic Reviews, MEDLINE (PubMed), and Embase (Elsevier). Studies were included if they were: relevant to CKD, assessed the effects of an intervention, and conducted in a country with an Ethnic Fractionalization Index (EFI) of greater than or equal to 0.3 or a composite EFI of 0.3.
Results: Of the initial 306 studies associated with CKD, 52 met all eligibility criteria for extraction in this study. Results from our systematic review showed only 6 trials mentioned recruitment strategies for historically marginalized groups, 11 mentioned a planned diversity goal, and just 3 reported any retention strategies. Additionally, only 5 studies listed limitations related to recruitment.
Conclusion: Our analysis highlights significant gaps in the recruitment and retention of participants from historically marginalized groups in CKD clinical trials. While U.S.-based studies show greater inclusivity efforts, overall strategies remain inadequate. Addressing these deficiencies requires targeted policies, evidence-based site selection, and inclusive recruitment practices. Future research should focus on broadening eligibility criteria and implementing validated strategies to enhance diversity, ultimately improving the generalizability and influence of CKD clinical trial outcomes.
| Original language | American English |
|---|---|
| Pages | 12 |
| State | Published - 13 Sep 2024 |
| Event | Symposium on Tribal and Rural Innovation in Disparities and Equity for Health - Tahlequah, United States Duration: 13 Sep 2024 → 13 Sep 2024 |
Conference
| Conference | Symposium on Tribal and Rural Innovation in Disparities and Equity for Health |
|---|---|
| Country/Territory | United States |
| City | Tahlequah |
| Period | 13/09/24 → 13/09/24 |