Insights From a User Experience‐Focused Virtual Study on the Feasibility and Challenges of Decentralized Clinical Trials
ABSTRACT The decentralized clinical trial (DCT) approach may potentially improve patient accrual and diversity and reduce logistical burden; however, its implementation in China is still in its infancy due to limited practical experience and guidance. We utilized stakeholder engagement research to s...
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| Format: | Article |
| Language: | English |
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Wiley
2025-08-01
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| Series: | Clinical and Translational Science |
| Online Access: | https://doi.org/10.1111/cts.70307 |
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| author | Yue Ma Le Li Gaili Gao Huan Zhou Jianmiao Yang Jiao Zheng Li Zheng Lu Zhang Min Jiang Pu Li Wenjing Zhou Xia Chen Ying Wang Weiyi Zheng Yan Zhang |
| author_facet | Yue Ma Le Li Gaili Gao Huan Zhou Jianmiao Yang Jiao Zheng Li Zheng Lu Zhang Min Jiang Pu Li Wenjing Zhou Xia Chen Ying Wang Weiyi Zheng Yan Zhang |
| author_sort | Yue Ma |
| collection | DOAJ |
| description | ABSTRACT The decentralized clinical trial (DCT) approach may potentially improve patient accrual and diversity and reduce logistical burden; however, its implementation in China is still in its infancy due to limited practical experience and guidance. We utilized stakeholder engagement research to simulate DCT processes and investigate their feasibility and applicability in a local context. This study, conducted between October 2023 and June 2024, engaged stakeholders to simulate the roles of the investigator, study nurse/pharmacist, and patient in a DCT, and explored feasibility, challenges, and procedures locally. Using a mixed‐method approach including focus group interviews, heuristic evaluation, usability testing, surveys, and one‐on‐one interviews, four DCT elements (eConsent, direct‐from‐patient sample collection, televisits, and direct‐to‐patient investigational medicine delivery) were simulated at 11 Chinese investigational sites with 36 researchers. Pain points, stakeholder requirements, and key challenges were identified; standardized procedures and a user journey map were developed to provide a visual representation of the DCT process, encouraging broader adoption. The researchers reported high satisfaction across all DCT elements. Key challenges included patients' DCT system process ease of use, lack of thoroughness or attention remotely, integrating online (system) and offline (hospital/home) visits, patient risk management, maintaining medication compliance remotely, and DCT system compatibility, among others. Standard procedures were developed for each DCT element, addressing issues like identity verification and data privacy based on user perspectives. This study provided insights on implementing DCTs in China, identifying areas that need optimization to meet local regulatory and stakeholders' requirements. The standardized framework may be referenced when adapting future DCT elements. |
| format | Article |
| id | doaj-art-c8b8467c0b4e42668a45a79bd237b532 |
| institution | Kabale University |
| issn | 1752-8054 1752-8062 |
| language | English |
| publishDate | 2025-08-01 |
| publisher | Wiley |
| record_format | Article |
| series | Clinical and Translational Science |
| spelling | doaj-art-c8b8467c0b4e42668a45a79bd237b5322025-08-23T17:10:42ZengWileyClinical and Translational Science1752-80541752-80622025-08-01188n/an/a10.1111/cts.70307Insights From a User Experience‐Focused Virtual Study on the Feasibility and Challenges of Decentralized Clinical TrialsYue Ma0Le Li1Gaili Gao2Huan Zhou3Jianmiao Yang4Jiao Zheng5Li Zheng6Lu Zhang7Min Jiang8Pu Li9Wenjing Zhou10Xia Chen11Ying Wang12Weiyi Zheng13Yan Zhang14Development Operations AstraZeneca Global R&D (China) Co., Ltd Shanghai ChinaGlobal User Experience AstraZeneca Investment (China) Co., Ltd Shanghai ChinaClinical Trial Institutions Office, GCP Office General Hospital of Ningxia Medical University Yinchuan Ningxia ChinaClinical Trials Center The First Affiliated Hospital of Bengbu Medical University Bengbu AnHui ChinaClinical Trial Institutions Office, GCP Office Taizhou Hospital of Zhejiang Taizhou Zhejiang ChinaClinical Trial Institutions Office, GCP Office Hainan General Hospital (Hainan Affiliated Hospital of Hainan Medical University) Haikou Hainan ChinaClinical Trial Center West China Hospital of Sichuan University Chengdu Sichuan ChinaClinical Trial Center Zhejiang Cancer Hospital Hangzhou ChinaBeijing Cancer Hospital Beijing ChinaClinical Trial Institutions Office, GCP Office The First Affiliated Hospital of Nanchang University Nanchang Jiangxi ChinaClinical Trial Center The University of Hong Kong—Shenzhen Hospital Shenzhen Guangdong ChinaClinical Trial Center Chongqing Cancer Hospital Chongqing ChinaClinical Trial Institutions Office, GCP Office Affiliated Hangzhou First People's Hospital Hangzhou Zhejiang ChinaDevelopment Operations AstraZeneca Global R&D (China) Co., Ltd Shanghai ChinaDevelopment Operations AstraZeneca Global R&D (China) Co., Ltd Shanghai ChinaABSTRACT The decentralized clinical trial (DCT) approach may potentially improve patient accrual and diversity and reduce logistical burden; however, its implementation in China is still in its infancy due to limited practical experience and guidance. We utilized stakeholder engagement research to simulate DCT processes and investigate their feasibility and applicability in a local context. This study, conducted between October 2023 and June 2024, engaged stakeholders to simulate the roles of the investigator, study nurse/pharmacist, and patient in a DCT, and explored feasibility, challenges, and procedures locally. Using a mixed‐method approach including focus group interviews, heuristic evaluation, usability testing, surveys, and one‐on‐one interviews, four DCT elements (eConsent, direct‐from‐patient sample collection, televisits, and direct‐to‐patient investigational medicine delivery) were simulated at 11 Chinese investigational sites with 36 researchers. Pain points, stakeholder requirements, and key challenges were identified; standardized procedures and a user journey map were developed to provide a visual representation of the DCT process, encouraging broader adoption. The researchers reported high satisfaction across all DCT elements. Key challenges included patients' DCT system process ease of use, lack of thoroughness or attention remotely, integrating online (system) and offline (hospital/home) visits, patient risk management, maintaining medication compliance remotely, and DCT system compatibility, among others. Standard procedures were developed for each DCT element, addressing issues like identity verification and data privacy based on user perspectives. This study provided insights on implementing DCTs in China, identifying areas that need optimization to meet local regulatory and stakeholders' requirements. The standardized framework may be referenced when adapting future DCT elements.https://doi.org/10.1111/cts.70307 |
| spellingShingle | Yue Ma Le Li Gaili Gao Huan Zhou Jianmiao Yang Jiao Zheng Li Zheng Lu Zhang Min Jiang Pu Li Wenjing Zhou Xia Chen Ying Wang Weiyi Zheng Yan Zhang Insights From a User Experience‐Focused Virtual Study on the Feasibility and Challenges of Decentralized Clinical Trials Clinical and Translational Science |
| title | Insights From a User Experience‐Focused Virtual Study on the Feasibility and Challenges of Decentralized Clinical Trials |
| title_full | Insights From a User Experience‐Focused Virtual Study on the Feasibility and Challenges of Decentralized Clinical Trials |
| title_fullStr | Insights From a User Experience‐Focused Virtual Study on the Feasibility and Challenges of Decentralized Clinical Trials |
| title_full_unstemmed | Insights From a User Experience‐Focused Virtual Study on the Feasibility and Challenges of Decentralized Clinical Trials |
| title_short | Insights From a User Experience‐Focused Virtual Study on the Feasibility and Challenges of Decentralized Clinical Trials |
| title_sort | insights from a user experience focused virtual study on the feasibility and challenges of decentralized clinical trials |
| url | https://doi.org/10.1111/cts.70307 |
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