Innovation and Exploration of Decentralized Clinical Trial(DCT):A Clinical Practice at West China Hospital
Decentralized clinical trial (DCT) is the clinical trial in which some or all of the trial related activities are conducted through remote and mobile/local healthcare outside of traditional clinical trial centers. As an innovative clinical research method,DCT implements the "patient-centered" drug development concept,which enables remote medical care,remote monitoring,and data collec-tion through electronic means. DCT can achieve flexibility and efficiency in clinical trials which is expected to break through geographical limitations. Personalized treatment plans can also be designed to meet the needs of patients,increasing their convenience and compliance in participating in trials. DCT is becoming an important strategy to address challenges in traditional clinical trials and will also be a key measure to improve the quality and efficiency of rare disease drug development. This study takes the "Clinical Study on Whole Life Cycle Blood Concentration Monitoring and Population Analysis of Mitotane in Chinese Adrenal Cortical Carcinoma Patients" conducted by West China Hospital of Sichuan University as an example to summarize the exploration and practice of decentralized clinical research on rare diseases using remote recruitment,electronic informed consent,remote blood collection,remote follow-up and other technologies in the Clinical Trial Center of West China Hospital,share the innovative measures and experience of West China Hospital in the application of DCT,explore how to use the DCT innovation model to accelerate the exploration and application of new technologies and methods in clini-cal research,to provide experience and reference for more DCT applications,and provide more effective and personalized medical solu-tions for patients.