Abstract
Objective: This cross-sectional study aims to evaluate the recruitment and retention strategies of historically marginalized populations in systemic lupus erythematosus (SLE) clinical trials.
Background: SLE, a complex autoimmune disease characterized by a dysregulated immune response leading to inflammation and tissue damage in multiple organ systems, exhibits a mortality rate four times higher in historically marginalized populations compared to the general population. It is essential for clinical trials to accurately represent the disease population to effectively evaluate treatment modalities. However, the current trial design lacks appropriate diversity, limiting the generalizability of results. Our study addresses this research gap by evaluating recruitment and retention strategies in SLE clinical trials.
Methods: Relevant clinical trials were obtained in a comprehensive search of MEDLINE (PubMed) and Embase (Elsevier) in May of 2024. Included trials were published between January 1, 2018 and December 31, 2023. Two reviewers independently performed screening and data extraction via a standardized Google Form.
Results: Of the 86 trials, only 4/86 (4.7%) implemented recruitment strategies while 6/86 (7.0%) reported use of specific retention strategies. Nineteen of the 86 studies (22.1%) reported challenges to recruitment of inequitable populations, primarily identifying the disproportionate representation of female participants and socioeconomic obstacles as a limitation.
Conclusion: Our study highlights the need for practical initiation of effective recruitment and retention strategies that aim to prioritize historically marginalized populations in SLE clinical trials. Addressing these gaps is necessary to prioritize participation of inequitable populations, increase standardization of SLE treatments, and improve the relevance of SLE research.
Background: SLE, a complex autoimmune disease characterized by a dysregulated immune response leading to inflammation and tissue damage in multiple organ systems, exhibits a mortality rate four times higher in historically marginalized populations compared to the general population. It is essential for clinical trials to accurately represent the disease population to effectively evaluate treatment modalities. However, the current trial design lacks appropriate diversity, limiting the generalizability of results. Our study addresses this research gap by evaluating recruitment and retention strategies in SLE clinical trials.
Methods: Relevant clinical trials were obtained in a comprehensive search of MEDLINE (PubMed) and Embase (Elsevier) in May of 2024. Included trials were published between January 1, 2018 and December 31, 2023. Two reviewers independently performed screening and data extraction via a standardized Google Form.
Results: Of the 86 trials, only 4/86 (4.7%) implemented recruitment strategies while 6/86 (7.0%) reported use of specific retention strategies. Nineteen of the 86 studies (22.1%) reported challenges to recruitment of inequitable populations, primarily identifying the disproportionate representation of female participants and socioeconomic obstacles as a limitation.
Conclusion: Our study highlights the need for practical initiation of effective recruitment and retention strategies that aim to prioritize historically marginalized populations in SLE clinical trials. Addressing these gaps is necessary to prioritize participation of inequitable populations, increase standardization of SLE treatments, and improve the relevance of SLE research.
| Original language | American English |
|---|---|
| Pages | 52 |
| State | Published - 13 Sep 2024 |
| Event | 2024 Symposium on Tribal and Rural Innovations in Disparities and Equity for Health - Oklahoma State University College of Osteopathic Medicine at the Cherokee Nation, Tahlequah, United States Duration: 13 Sep 2024 → 13 Sep 2024 |
Conference
| Conference | 2024 Symposium on Tribal and Rural Innovations in Disparities and Equity for Health |
|---|---|
| Abbreviated title | STRIDE 2024 |
| Country/Territory | United States |
| City | Tahlequah |
| Period | 13/09/24 → 13/09/24 |