location: nan, 'Thailand 
year: 2023 source: HSRI 
title: Development of Data Monitoring and Safety Monitoring of Clinical Trial of Thai Herbal Medicine 
abstract:The two research projects used similar study designs and data collection methods but differed in the interventions being tested. Chao Phraya Abhaiphubejhr Hospital study site used herbal product produced by Chao Phraya Abhaibhubejhr Hospital (a powdered form of herbal medicine) while Saraburi Hospital used Andrographis paniculata extract, a product of GPO. Therefore, the data cannot be analyzed together, particularly when it is known that the absorption of powdered form has less bioavailability. Conducting clinical research during a rapidly mutating COVID-19 global pandemic with varying species and symptoms is challenging. Changes in treatment policies by the public health authority further complicate research efforts to prove the efficacy of Andrographis paniculate. Using a pragmatic trial design with GCP concepts during a pandemic may be more responsive to policy decisions and worth investing in. The studies were conducted under the concepts of GCP with intensive safety monitoring which resulted in ethically and scientifically reliable research. The research found that the use of Andrographis paniculata, whether in powder or extract form of more than five days, can lead to abnormal liver function. This emphasizes the importance of quality data from proper study design and good monitoring throughout the trial. Issuing treatment policies with evidence from poor study design and inadequate or no monitoring of the study conduct, together with publicizing the use of herbs on a large scale to the public will do more harm than good. The establishment of a data and safety oversight committee and preliminary statistical analysis from the beginning of research projects will help to speed up the research process, reduce risks to patients, and lower research costs. Designing the research project by planning ahead for a data and safety oversight committee and preliminary statistical analysis during the research can hasten the development process and will reduce the risk to patients as well as the costs of conducting and monitoring research. Health Systems Research Institute (HSRI) should provide training for personnel to increase the number of study monitors. In the case where HSRI is unable to do so on its own, sufficient budget should be provided to hire external clinical monitors to monitor data recording and reporting during the research, overseeing the management of data recorded in the computer system. This is an important role of research sponsors according to good clinical research practice standards to ensure accurate data recording and reporting. In addition, HSRI should provide or support budgets for a computerized data management system that can automatically verify accurate data recording. Examples of research data management programs are Redcap or NCRC program for accurate data analysis, the system can check for corrections during the research until the completion of the research project. This is in order to raise the standard of clinical research in Thailand. In the future, it is desirable for the public health service agencies to prepare health information in a standard format such as HL7 FHIR13, so that the hospitals can share patient health information between hospitals. Data from different hospitals can be analyzed for various forms of treatment, comparing Andrographis paniculate treatment with other types of treatment, it can lead to decisions that respond more appropriate to the COVID outbreak situation. Good example is the big data link of the United Kingdom during the COVID-19 outbreak which has led to the establishment of data for national research14 Using big data for research purposes has the potential to provide valuable insights. The HSRI should play a role in promoting the creation of knowledge and understanding of big data research and providing budgets for big data research to personnel involved in such research, whether it is a researcher, Research Ethics Committee, Hospital administrator or officials of the institute to support such research that concurs with the mission of the HSRI and further development of medical and health innovations in the country.