RESUMO
Decentralized clinical trials （DCT） are bringing new changes to clinical trials， the core concept of “patient-centered” must be adhered， and the safety and rights of research participants must be adequately safeguarded. Although DCTs have similarities with traditional clinical trials， they are not suitable for all clinical trials， and are more suitable for oral administration， stable condition of study participants， and longer duration of treatment in clinical trials. DCT， elements must be selected based on the characteristics of clinical trials， and strike a balance between improving the sense of gain， safety， and rights and dignity of research participants， as well as the quality of data collected. Currently， DCT in China face many challenges. To actively promote DCTs in China， regulatory regulations and guiding principles should be improved. Based on patient-centered design principles， the first discussion requires real-time online communication. Researchers should provide more clinical trial services， improve risk control and accessibility of medical assistance， use third-party convenient payments， ensure fair recruitment of research participants， consider compliance， validate digital health technology， remote monitoring and electronic informed consent compliance， ensure the security of data collection， transmission， and analysis， as well as strengthen multi-party training. Ethical review is one of the important means to protect the safety and rights of research participants. Ethics committees should focus on appropriate DCTs elements that are patient-centered， compliance and effectiveness of electronic informed consent， processing and reporting of security information， privacy protection of data collection， compliance of remote monitoring， family health follow-up， management of biological samples and experimental medical products， and training programs. The author believed that the complementarity and combination with traditional clinical trials will make DCTs elements implemented more easily and smoothly. By leveraging the power of scientific and technological advances， DCTs will boost the speed of China’s drug and medical device research and development， enhance international competitiveness， and benefit more patients.
RESUMO
The Regulations on Donation and Transplantation of Human Organs were issued on December 14， 2023. It was interpreted in terms of improving the human organ donation system and clarifying the responsibilities of the Red Cross Society； adding a new system for the acquisition and distribution of human organs， emphasizing the independence of the organ acquisition department， and implementing the priority right of organ distribution； strengthening the management of human organ transplantation， strictly limiting the scope of recipients of living organ transplantation； and regulating the operation of the ethics committee for human organ transplantation and stepping up the crackdown on violations of the regulations. This paper then considered how to implement and improve incentives for human organ donation， including the implementation of the priority rights of organ donors and their close relatives， the improvement of the organ donation compensation system， and the establishment of a humanitarian assistance system； the implementation of a system for the acquisition and distribution of organ donation organization； the acceleration of the construction of the personnel team of the organ acquisition organization； the increase of efforts to advocate and mobilise； and the enhancement of the construction of the ethics committee for human organ transplantation. The Regulations on Donation and Transplantation of Human Organs help to give fuller play to the enthusiasm and creativity in the field of organ transplantation， and all departments should revise the systems and administrative rules relating to human organ donation and transplantation in time， so as to facilitate the work of donation and transplantation of human organ.