RESUMEN
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.
RESUMEN
In recent years， with the gradual maturity of achievable remote collection of digital health technology， more and more clinical research have applied this technology to improve the quality of data collection and reduce the burden on subjects. However， its technological characteristics of detachment from the diagnostic and treatment environment and real-time transmission of sensitive information also pose corresponding risks to the protection of subjects’ rights and interests and data standardization management， among which personal information protection and data control permissions are more prominent issues. Based on risk analysis and regulatory review， this paper explored the responsibilities of multiple parties， including the sponsors， researchers， clinical trial institutions， and ethics committee， as well as proposed five elements of special concern for ethical review， with a view to providing a reference for promoting the standardized development of digital health technology in clinical research.
RESUMEN
Aims:To identify virtual healthcare services and digital health technologies deployed in South Africa during coronavirus disease 2019(COVID-19)and the challenges associated with their use.Methods:To determine the status of digital health utilization during COVID-19 in South Africa,the preferred reporting items for systematic reviews and meta-analyses model was used to perform a systematic and in-depth critical analysis of previously published studies in well-known and trusted online electronic databases using specific search keywords words that are relevant to this study.We selected published peer-reviewed articles available from the onset of COVID-19 to July 2021.Results:Total of 24 articles were included into this study.This study revealed that South Africa adopted digital technologies such as SMS-based solutions,mobile health applications,telemedicine and telehealth,WhatsApp-based systems,artificial intelligence and chatbots and robotics to provide healthcare services during COVID-19 pandemic.These innovative technologies have been used for various purposes including screening infectious and non-infectious diseases,disease surveillance and monitoring,medication and treatment compliance,creating awareness and communication.The study also revealed that teleconsultation and e-prescription,telelaboratory and telepharmacy,teleeducation and teletraining,teledermatology,teleradiology,telecardiology,teleophthal-mology,teleneurology,telerehabilitation,teleoncology and telepsychiatry are among virtual healthcare services delivered through digital health technologies during COVID-19 in South Africa.However,these smart digital health technologies face several impediments such as infrastructural and technological barriers,organization and financial barriers,policy and regulatory barriers as well as cultural barriers.Conclusion:Although COVID-19 has invigorated the use of digital health technologies,there are still some short-comings.The outbreak of pandemics like COVID-19 in the future is not inevitable.Therefore,we recommend increasing community networks in rural areas to bridge the digital divide and the modification of mHealth pol-icy to advocate for the effective use of innovative technologies in healthcare and the development of sustainable strategies for resources mobilization through private-public partnerships as well as joining available international initiatives advocating for smart digital health.