Expert consensus on the implementation of Direct-to-Patient model in clinical trials
JIANG Min
LIU Xiao-hong
FANG Hong
QIU Qi
FU Zhi-ying
YUAN Yan-nan
ZHAO Shu-hua
REN Wei
Abstract：This article focuses on the Direct-to-Patient(DTP)model in clinical trials,expounding on its definition,objectives,applicable scenarios,and regulatory requirements.The DTP model is particularly suitable for clinical trial participants who experience mobility difficulties,live in remote areas,or are patients with chronic diseases or tumors requiring long-term medication.During the implementation process,it is necessary to meet regulatory and qualification requirements,and clarify the responsibilities of various parties such as sponsors,research centers,investigators,and suppliers.The operation process covers multiple aspects,covering drug distribution,risk assessment and management,protection of participants'rights and interests,monitoring and auditing,informatization construction,and data management.The article aims to provide comprehensive guidance on implementation pathways for sponsors,research institutions,logistics service providers,and other relevant parties.It seeks to safeguard the rights and interests of clinical trial participants,while enhancing both convenience and efficiency of clinical trials.In the future,all parties need to work together to improve DTP regulations,strengthen industry norms and standardization construction,enhance service capabilities,strengthen publicity and training,and explore effective quality control and supervision methods,so as to promote its standardized application and development in the field of clinical trials.
Keywords：Direct-to-Patient modelclinical trialsdrug distributionprotection of participants'rights and interestsmulti-party collaboration
Publication Date：2025-11-15
Online Publishing Date：2026-08-14(First online date of this platform, not the publication date of the document)
Pages：10( 2306-2315 )