Demographic clinical trial diversity assessment methods: Use of real-world data
Diversity in clinical trials is defined by the inclusion of clinical trial participants from various demographic groups that are representative of the broader population impacted by a disease state. Diversity in clinical trials is critical in identifying potential differences in safety and efficacy...
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| Format: | Article |
| Language: | English |
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Elsevier
2025-04-01
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| Series: | Contemporary Clinical Trials Communications |
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| Online Access: | http://www.sciencedirect.com/science/article/pii/S2451865425000067 |
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| author | Hua Chen Nnadozie Emechebe Sudeep Karve Leon Raskin Jailene Leal Ning Cheng Wendy Sebby Kim Ribeiro Samuel Crawford |
| author_facet | Hua Chen Nnadozie Emechebe Sudeep Karve Leon Raskin Jailene Leal Ning Cheng Wendy Sebby Kim Ribeiro Samuel Crawford |
| author_sort | Hua Chen |
| collection | DOAJ |
| description | Diversity in clinical trials is defined by the inclusion of clinical trial participants from various demographic groups that are representative of the broader population impacted by a disease state. Diversity in clinical trials is critical in identifying potential differences in safety and efficacy of treatments across races, ethnicities, ages, sexes, or other variables. In the United States, clinical trial diversity is often benchmarked against US Census data, which may limit the representativeness of patient demographics in clinical trials. Disease-specific, demographic estimates from real-world data (RWD) can facilitate benchmarking of clinical trials, support trial enrollment and the development of trial diversity plans. Notably, development and dissemination of these estimates from RWD can be challenging without a standardized process. To address this issue, we developed a new evaluation framework to assess patient demographics and characteristics within specific disease populations using RWD and disease population estimates.Suitable databases were identified using predefined criteria such as accessibility to patient-level data, availability of all demographic variables of interest, sufficient sample size of the disease population, and availability of population weights to enhance generalizability. Concurrent data were gathered via targeted literature reviews for each disease condition. Together, this data was used to create disease-specific, demographic estimate profiles to inform diverse enrollment goals for prospective clinical trials. We present two examples of application of this framework to illustrate the results in the case of two disease states, rheumatoid arthritis and stroke. |
| format | Article |
| id | doaj-art-3bb0e45509fb43ccb9ac473cea6d9bd5 |
| institution | Kabale University |
| issn | 2451-8654 |
| language | English |
| publishDate | 2025-04-01 |
| publisher | Elsevier |
| record_format | Article |
| series | Contemporary Clinical Trials Communications |
| spelling | doaj-art-3bb0e45509fb43ccb9ac473cea6d9bd52025-02-05T04:32:23ZengElsevierContemporary Clinical Trials Communications2451-86542025-04-0144101432Demographic clinical trial diversity assessment methods: Use of real-world dataHua Chen0Nnadozie Emechebe1Sudeep Karve2Leon Raskin3Jailene Leal4Ning Cheng5Wendy Sebby6Kim Ribeiro7Samuel Crawford8Department of Pharmaceutical Health Outcomes and Policy, College of Pharmacy, University of Houston, USAAbbVie, Inc, North Chicago, IL, USAAbbVie, Inc, North Chicago, IL, USAAbbVie, Inc, North Chicago, IL, USAAbbVie, Inc, North Chicago, IL, USAAbbVie, Inc, North Chicago, IL, USAAbbVie, Inc, North Chicago, IL, USAAbbVie, Inc, North Chicago, IL, USAAbbVie, Inc, North Chicago, IL, USA; Corresponding author.Diversity in clinical trials is defined by the inclusion of clinical trial participants from various demographic groups that are representative of the broader population impacted by a disease state. Diversity in clinical trials is critical in identifying potential differences in safety and efficacy of treatments across races, ethnicities, ages, sexes, or other variables. In the United States, clinical trial diversity is often benchmarked against US Census data, which may limit the representativeness of patient demographics in clinical trials. Disease-specific, demographic estimates from real-world data (RWD) can facilitate benchmarking of clinical trials, support trial enrollment and the development of trial diversity plans. Notably, development and dissemination of these estimates from RWD can be challenging without a standardized process. To address this issue, we developed a new evaluation framework to assess patient demographics and characteristics within specific disease populations using RWD and disease population estimates.Suitable databases were identified using predefined criteria such as accessibility to patient-level data, availability of all demographic variables of interest, sufficient sample size of the disease population, and availability of population weights to enhance generalizability. Concurrent data were gathered via targeted literature reviews for each disease condition. Together, this data was used to create disease-specific, demographic estimate profiles to inform diverse enrollment goals for prospective clinical trials. We present two examples of application of this framework to illustrate the results in the case of two disease states, rheumatoid arthritis and stroke.http://www.sciencedirect.com/science/article/pii/S2451865425000067Clinical trial diversityReal-world dataRWDDisease populationHealth equityDiversity plan |
| spellingShingle | Hua Chen Nnadozie Emechebe Sudeep Karve Leon Raskin Jailene Leal Ning Cheng Wendy Sebby Kim Ribeiro Samuel Crawford Demographic clinical trial diversity assessment methods: Use of real-world data Contemporary Clinical Trials Communications Clinical trial diversity Real-world data RWD Disease population Health equity Diversity plan |
| title | Demographic clinical trial diversity assessment methods: Use of real-world data |
| title_full | Demographic clinical trial diversity assessment methods: Use of real-world data |
| title_fullStr | Demographic clinical trial diversity assessment methods: Use of real-world data |
| title_full_unstemmed | Demographic clinical trial diversity assessment methods: Use of real-world data |
| title_short | Demographic clinical trial diversity assessment methods: Use of real-world data |
| title_sort | demographic clinical trial diversity assessment methods use of real world data |
| topic | Clinical trial diversity Real-world data RWD Disease population Health equity Diversity plan |
| url | http://www.sciencedirect.com/science/article/pii/S2451865425000067 |
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