Abstract
Importance: Chronic kidney disease (CKD) affects over 800 million people worldwide, imposing a significant economic burden and reducing life expectancy, particularly among women, racial minorities, and older individuals. Diverse representation in clinical trials is crucial for developing effective treatments that are applicable to all groups.
Objective: To evaluate the diversity and representation of CKD clinical trial populations regarding sex, race, and ethnicity.
Data Sources: MEDLINE (PubMed), Embase (Elsevier).
Data Extraction and Synthesis: Trial characteristics and demographics (sex, age, race, ethnicity) were extracted using a standardized Google form. For each trial, participation-to-disease representation ratios (PDRRs) were calculated for each group to evaluate participant group representation relative to the disease population. Additionally, Clinical Diversity Rating scores were calculated.
Main Outcome(s) and Measure(s): PDRR and Clinical Diversity Rating scores for sex, age, race, and ethnicity.
Results: Our search string initially returned 306 records. Deduplication and title and abstract screening resulted in 101 articles. Full-text screening revealed 24 clinical trials were eligible for extraction. Only 1/24 (4.2%) was 'Good' for race/ethnicity, while 13/24 (54.2%) were 'Poor'. Regarding female sex, 7/24 (29.2% were 'Poor, 7/24 (29.2%) were 'Fair, and 10/24 (41.6%) were 'Good.' The only trial reporting older adults was 'Good'. Meta-analysis showed only 1/24 (4.2%) had a PDRR above 0.8 for Asians, while 18/24 (75%) of trials had a PDRR above 1.2 for whites. Hispanic/Latinx were underrepresented in 14/24 (58.3%) trials. Blacks were adequately or over represented in 16/24 (66.7%) trials. Males were overrepresented in 17/2 (70.8% trials and females were underrepresented in 14/24 (58.3%) trials.
Conclusions and Relevance: CKD clinical trials consistently overrepresented Male and white populations while underrepresenting females, Asians, and Hispanic/Latinx. Trialists should employ strategies to reach a more representative sample of the disease population. These changes would ensure treatments and therapies are better suited to all individuals with CKD.
Objective: To evaluate the diversity and representation of CKD clinical trial populations regarding sex, race, and ethnicity.
Data Sources: MEDLINE (PubMed), Embase (Elsevier).
Data Extraction and Synthesis: Trial characteristics and demographics (sex, age, race, ethnicity) were extracted using a standardized Google form. For each trial, participation-to-disease representation ratios (PDRRs) were calculated for each group to evaluate participant group representation relative to the disease population. Additionally, Clinical Diversity Rating scores were calculated.
Main Outcome(s) and Measure(s): PDRR and Clinical Diversity Rating scores for sex, age, race, and ethnicity.
Results: Our search string initially returned 306 records. Deduplication and title and abstract screening resulted in 101 articles. Full-text screening revealed 24 clinical trials were eligible for extraction. Only 1/24 (4.2%) was 'Good' for race/ethnicity, while 13/24 (54.2%) were 'Poor'. Regarding female sex, 7/24 (29.2% were 'Poor, 7/24 (29.2%) were 'Fair, and 10/24 (41.6%) were 'Good.' The only trial reporting older adults was 'Good'. Meta-analysis showed only 1/24 (4.2%) had a PDRR above 0.8 for Asians, while 18/24 (75%) of trials had a PDRR above 1.2 for whites. Hispanic/Latinx were underrepresented in 14/24 (58.3%) trials. Blacks were adequately or over represented in 16/24 (66.7%) trials. Males were overrepresented in 17/2 (70.8% trials and females were underrepresented in 14/24 (58.3%) trials.
Conclusions and Relevance: CKD clinical trials consistently overrepresented Male and white populations while underrepresenting females, Asians, and Hispanic/Latinx. Trialists should employ strategies to reach a more representative sample of the disease population. These changes would ensure treatments and therapies are better suited to all individuals with CKD.
| Original language | American English |
|---|---|
| Pages | 7 |
| 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 |