The value of decentralized clinical trials: Inclusion, accessibility, and innovation

• 成果类型: Review
• 署名作者: Jean-Louis, Girardin; Seixas, Azizi A.
• 署名单位: University of Miami; University of Miami; University of Miami
• 刊物名称: SCIENCE
• ISSN/ISSBN: 0036-12442
• DOI: 10.1126/science.adq4994
• 发表日期: 2024-08-23
• 关键词: maintaining data integrity; assessment hta decisions; real-world evidence; transparency policies; african-americans; PARTICIPATION; HEALTH; RECRUITMENT; CHALLENGES; incentives

摘要

BACKGROUND Decentralized clinical trials (DCTs) are innovative approaches to clinical research that leverage digital technologies to address the limitations of traditional site-based trials. Traditional trials often face barriers such as geographical constraints, lack of diversity among participants, and logistical challenges, limiting participant engagement and retention. These issues are particularly pronounced for historically marginalized groupings, who often experience greater obstacles in accessing health care and participating in clinical research. Traditional site-based trials typically require participants to travel to specific locations for screening, intervention, and follow-up procedures. This approach often excludes individuals who live in remote areas or do not have adequate transportation means, limiting the diversity and representativeness of the study population. Additionally, logistical issues such as requirements for time off from work, caregiving responsibilities, and transportation costs further hinder participation for individuals in such communities. DCTs overcome these barriers by leveraging digital technologies and real-world data to increase inclusivity and accessibility in clinical research. DCTs enable participants to engage in clinical trials from the comfort of their homes by using telemedicine, mobile health applications, and remote monitoring devices. Expanded inclusivity and accessibility promote greater insights regarding how treatments work across varying demographics and ensure that novel therapies are effective for the entire population. BACKGROUND Decentralized clinical trials (DCTs) are innovative approaches to clinical research that leverage digital technologies to address the limitations of traditional site-based trials. Traditional trials often face barriers such as geographical constraints, lack of diversity among participants, and logistical challenges, limiting participant engagement and retention. These issues are particularly pronounced for historically marginalized groupings, who often experience greater obstacles in accessing health care and participating in clinical research. Traditional site-based trials typically require participants to travel to specific locations for screening, intervention, and follow-up procedures. This approach often excludes individuals who live in remote areas or do not have adequate transportation means, limiting the diversity and representativeness of the study population. Additionally, logistical issues such as requirements for time off from work, caregiving responsibilities, and transportation costs further hinder participation for individuals in such communities. DCTs overcome these barriers by leveraging digital technologies and real-world data to increase inclusivity and accessibility in clinical research. DCTs enable participants to engage in clinical trials from the comfort of their homes by using telemedicine, mobile health applications, and remote monitoring devices. Expanded inclusivity and accessibility promote greater insights regarding how treatments work across varying demographics and ensure that novel therapies are effective for the entire population. BACKGROUND Decentralized clinical trials (DCTs) are innovative approaches to clinical research that leverage digital technologies to address the limitations of traditional site-based trials. Traditional trials often face barriers such as geographical constraints, lack of diversity among participants, and logistical challenges, limiting participant engagement and retention. These issues are particularly pronounced for historically marginalized groupings, who often experience greater obstacles in accessing health care and participating in clinical research. Traditional site-based trials typically require participants to travel to specific locations for screening, intervention, and follow-up procedures. This approach often excludes individuals who live in remote areas or do not have adequate transportation means, limiting the diversity and representativeness of the study population. Additionally, logistical issues such as requirements for time off from work, caregiving responsibilities, and transportation costs further hinder participation for individuals in such communities. DCTs overcome these barriers by leveraging digital technologies and real-world data to increase inclusivity and accessibility in clinical research. DCTs enable participants to engage in clinical trials from the comfort of their homes by using telemedicine, mobile health applications, and remote monitoring devices. Expanded inclusivity and accessibility promote greater insights regarding how treatments work across varying demographics and ensure that novel therapies are effective for the entire population. ADVANCES DCTs have introduced innovative solutions that greatly enhance the inclusion of diverse participant demographics and accessibility to clinical trials. Because DCTs use digital technologies, they are preferred in study designs with low-to-medium complexities. They are especially useful in cases where patients present with chronic diseases or clinical conditions, have limited ability to ambulate freely, use self-administrable investigational products, and have low safety risk profile. They may also be ideal in confirmatory clinical trials. Key components of successful DCTs include advanced encryption, secure data storage solutions, and comprehensive privacy policies, all of which are necessary to prevent data breaches and maintain participant trust. Other security measures involve accurate and reliable remote monitoring to enhance the validity of DCT outcomes; the use of standardized protocols to streamline the trial processes is also vital. DCTs must address the social determinants of health to maximize participation and engagement. Providing access to digital tools and internet connectivity is essential for equitable participation. Enhancing digital literacy through education and support empowers individuals to engage effectively with digital platforms. Offering social support, such as assistance with technology navigation, is also essential. ADVANCES DCTs have introduced innovative solutions that greatly enhance the inclusion of diverse participant demographics and accessibility to clinical trials. Because DCTs use digital technologies, they are preferred in study designs with low-to-medium complexities. They are especially useful in cases where patients present with chronic diseases or clinical conditions, have limited ability to ambulate freely, use self-administrable investigational products, and have low safety risk profile. They may also be ideal in confirmatory clinical trials. Key components of successful DCTs include advanced encryption, secure data storage solutions, and comprehensive privacy policies, all of which are necessary to prevent data breaches and maintain participant trust. Other security measures involve accurate and reliable remote monitoring to enhance the validity of DCT outcomes; the use of standardized protocols to streamline the trial processes is also vital. DCTs must address the social determinants of health to maximize participation and engagement. Providing access to digital tools and internet connectivity is essential for equitable participation. Enhancing digital literacy through education and support empowers individuals to engage effectively with digital platforms. Offering social support, such as assistance with technology navigation, is also essential. OUTLOOK DCT modalities are promising, offering a transformative advantage over traditional clinical trials. However, several challenges must be addressed. Ensuring robust data security and privacy is paramount because heavy reliance on digital technologies increases the risk of data breaches. High-quality remote patient monitoring must be maintained to ensure the validity of trial outcomes, and regulatory variations across regions need to be addressed to facilitate broader DCT adoption. Future research should focus on developing standardized protocols and technologies to streamline DCT processes and improve participant enrollment and retention. Additionally, it is crucial to explore the long-term impacts of DCTs on patient outcomes and trial efficiency. Successful implementation of DCT requires building multidisciplinary teams with expertise from various fields, including clinical research, regulatory affairs, technology development, and data science, as well as including community health champions. Coalescing a team with varying expertise will foster innovative solutions to address the complex challenges associated with implementing DCTs. Given the recognition that digital technologies alone may be insufficient, it is crucial to provide access to support teams. The promising future of DCTs lies in the collective commitment and collaboration of all stakeholders to revolutionize clinical research by making it more democratic and equitable, leading to better health outcomes for all. The use of TeleVisits in decentralized clinical trials is becoming more common. PHOTO: ISTOCK.COM/PROSTOCK-STUDIO OUTLOOK DCT modalities are promising, offering a transformative advantage over traditional clinical trials. However, several challenges must be addressed. Ensuring robust data security and privacy is paramount because heavy reliance on digital technologies increases the risk of data breaches. High-quality remote patient monitoring must be maintained to ensure the validity of trial outcomes, and regulatory variations across regions need to be addressed to facilitate broader DCT adoption. Future research should focus on developing standardized protocols and technologies to streamline DCT processes and improve participant enrollment and retention. Additionally, it is crucial to explore the long-term impacts of DCTs on patient outcomes and trial efficiency. Successful implementation of DCT requires building multidisciplinary teams with expertise from various fields, including clinical research, regulatory affairs, technology development, and data science, as well as including community health champions. Coalescing a team with varying expertise will foster innovative solutions to address the complex challenges associated with implementing DCTs. Given the recognition that digital technologies alone may be insufficient, it is crucial to provide access to support teams. The promising future of DCTs lies in the collective commitment and collaboration of all stakeholders to revolutionize clinical research by making it more democratic and equitable, leading to better health outcomes for all. The use of TeleVisits in decentralized clinical trials is becoming more common. PHOTO: ISTOCK.COM/PROSTOCK-STUDIO