Objective To introduce the concept and plan design of pragmatic clinical trials based on real-world study(RWS)so as to provide both guidance for clinical trials and reference for relevant personnel studying RWS.Method...Objective To introduce the concept and plan design of pragmatic clinical trials based on real-world study(RWS)so as to provide both guidance for clinical trials and reference for relevant personnel studying RWS.Methods A retrospective study was made on the design of real-world clinical trials at home and abroad in recent years to summarize their design process and applications.Results and Conclusion The advantages of combining randomization and real-world data in clinical trials are important methods for evaluating medical interventions in the real clinical environment.Practical clinical trials can evaluate the therapeutic effects of interventions in real or close to real medical environments to obtain the best real-world evidence.展开更多
To present the advances of evidence-based medicine and clinical research methodology in integrative oncology,we conducted a literature review of real-world studies of traditional Chinese medicine(TCM)in cancer care an...To present the advances of evidence-based medicine and clinical research methodology in integrative oncology,we conducted a literature review of real-world studies of traditional Chinese medicine(TCM)in cancer care and summarized the available evidence.Pragmatic randomized controlled trials(pRCTs)and clinical registry studies are becoming more popular as they could compensate for the limitations of RCTs.Many RCTs of TCM for cancer treatment as well as systematic reviews have been published.The most investigated therapies are based on acupuncture,Chinese herbal compounds,and Chinese patent medicines.Acupuncture has a significant advantage in relieving cancer-related symptoms.Published studies focus more on improving clinical symptoms and laboratory indicators.However,the patient's quality of life deserves more attention.展开更多
Over the last few years a number of large acupuncture trials have been carried out in western countries. The following article draws on the experience from these recent large-scale trials on acupuncture to outline the...Over the last few years a number of large acupuncture trials have been carried out in western countries. The following article draws on the experience from these recent large-scale trials on acupuncture to outline the way randomized trials could be used to answer questions on efficacy, effectiveness and efficiency. It will provide guidance, firstly on the underlying concepts of both efficacy and effectiveness and secondly on designing both types of trials. In addition, the controversy over specific and non-specific effects of acupuncture, emerging from the results of the above-mentioned trials, will be highlighted. Suggestions for future clinical research on acupuncture include： greater reflection on the complex approach of Chinese medicine, and transparent and detailed reporting according to CONSORT and STRICTA guidelines. The current data on acupuncture point-specific effects do indeed have relevance, however for valid decision-making on acupuncture, further clinical trials on effectiveness and cost-effectiveness are required to provide realistic benefit estimates for future health care.展开更多
基金Special Fund of the National Medical Products Administration’s Drug Regulatory Science Research Base-Research Institute of Drug Regulatory Science of Shenyang Pharmaceutical University(No.2020jgkx005).
文摘Objective To introduce the concept and plan design of pragmatic clinical trials based on real-world study(RWS)so as to provide both guidance for clinical trials and reference for relevant personnel studying RWS.Methods A retrospective study was made on the design of real-world clinical trials at home and abroad in recent years to summarize their design process and applications.Results and Conclusion The advantages of combining randomization and real-world data in clinical trials are important methods for evaluating medical interventions in the real clinical environment.Practical clinical trials can evaluate the therapeutic effects of interventions in real or close to real medical environments to obtain the best real-world evidence.
基金This study was supported by the Key Project of the National Natural Science Foundation of China(81830115).
文摘To present the advances of evidence-based medicine and clinical research methodology in integrative oncology,we conducted a literature review of real-world studies of traditional Chinese medicine(TCM)in cancer care and summarized the available evidence.Pragmatic randomized controlled trials(pRCTs)and clinical registry studies are becoming more popular as they could compensate for the limitations of RCTs.Many RCTs of TCM for cancer treatment as well as systematic reviews have been published.The most investigated therapies are based on acupuncture,Chinese herbal compounds,and Chinese patent medicines.Acupuncture has a significant advantage in relieving cancer-related symptoms.Published studies focus more on improving clinical symptoms and laboratory indicators.However,the patient's quality of life deserves more attention.
文摘Over the last few years a number of large acupuncture trials have been carried out in western countries. The following article draws on the experience from these recent large-scale trials on acupuncture to outline the way randomized trials could be used to answer questions on efficacy, effectiveness and efficiency. It will provide guidance, firstly on the underlying concepts of both efficacy and effectiveness and secondly on designing both types of trials. In addition, the controversy over specific and non-specific effects of acupuncture, emerging from the results of the above-mentioned trials, will be highlighted. Suggestions for future clinical research on acupuncture include： greater reflection on the complex approach of Chinese medicine, and transparent and detailed reporting according to CONSORT and STRICTA guidelines. The current data on acupuncture point-specific effects do indeed have relevance, however for valid decision-making on acupuncture, further clinical trials on effectiveness and cost-effectiveness are required to provide realistic benefit estimates for future health care.
