Introduction The mission of the WHO International Clinical Trials Registry Platform is to ensure that a complete view of research is accessible to all those involved in health care decision making. This will improve r...Introduction The mission of the WHO International Clinical Trials Registry Platform is to ensure that a complete view of research is accessible to all those involved in health care decision making. This will improve research transparency and will ultimately strengthen the validity and value of the scientific evidence base. The registration of all interventional trials is a scientific, ethical and moral responsibility.展开更多
Objectives: Our aim was to clarify the study characteristics of countries that have registered clinical trials studies and to calculate the percentage of clinical trials that were registered in each country’s registr...Objectives: Our aim was to clarify the study characteristics of countries that have registered clinical trials studies and to calculate the percentage of clinical trials that were registered in each country’s registry, and try to find and evaluate the factors determining that percentage. Design and Methods: The present study is a cross-sectional study using data from clinical trials registered from January 1, 2011, to December 31, 2015. Only countries with more than 2000 registered trials were included for further study. Ten countries met that criterion: United States, Japan, Iran, Australia, New Zealand, China, India, Germany, United Kingdom, and Netherland. The percentage of clinical trials that were registered in each country’s registry was calculated, and the factors determining that percentage were sought and analyzed through an exploratory approach. Results: The chi-squared test of independence indicated that the rate of clinical trial registration significantly differed between countries. From the adjusted standardized residuals, the percentage of clinical trials that were registered in the country of origin was higher in the United States, India, Japan, and Australia/New Zealand than in the European Union and China. Conclusion: The United States requires that informed consent documents for clinical trials contain clinical trial registration numbers from ClinicalTrials.gov, which could be the reason for the extremely high percentage of registered clinical trials (94%). Since the European Union does not have this requirement, clinical trials conducted in the European Union do not have to be registered in the countries in which they are conducted.展开更多
Objective:To analyze clinical trials of traditional medicine(including Chinese herbal medicine and nonpharmacological therapies)for the treatment of type 2 diabetes mellitus(T2DM)registered in the International Clinic...Objective:To analyze clinical trials of traditional medicine(including Chinese herbal medicine and nonpharmacological therapies)for the treatment of type 2 diabetes mellitus(T2DM)registered in the International Clinical Trials Registry Platform(ICTRP),and accordingly to explore their clinical trial registration characteristics,development trend and intervention status,in an attempt to provide references for future research design,diagnosis and management of traditional Chinese medicine therapy for T2DM.Methods:The clinical trials related to Chinese herbal medicine and nonpharmacological therapies for treating T2DM were retrieved on the ICTRP online from the time of database construction to August 13,2023,to analyze the time of registration,country and institution of the study,source of funding,type and design of the study,randomization and blinding methods,clinical staging,therapeutic measures,and main therapeutic effect indexes.Descriptive statistical analysis was performed using R4.3.0 and Excel software.Results:A total of 774 clinical trials for T2DM treatment were included,of which 127 were traditional herbal therapies and 647 were nonpharmacological therapies.The T2DM clinical trial registration institutions were distributed in 50 countries worldwide involving 15 clinical registration platforms,with the most registrations in Iran,China,and Australia,and the top 3 registration platforms were the Iranian Clinical Trial Registry,the Australian New Zealand Clinical Trials Registry,and the ICTRP.Universities(551,71.19%)were the main funding sources.Intervention studies(750,96.90%)were the primary study type,including randomized controlled trials(432,56.4%),and 225 studies mentioned the blinding method.A total of 530(68.48%)with a sample size≤100 were included.Study phases were predominantly phase 2 and phase 3(108,51.43%).The interventions of traditional medicine for T2DM were composed of Chinese herbal medicines(mainly ginseng and astragalus compound),nonpharmacological therapies(mainly exercise and diet therapies),and 2 or more comprehensive treatment regimes.According to the type of study design,the first 3 main therapeutic indexes were fasting blood glucose(286 times),glycated hemoglobin(282 times),and insulin resistance(120 times),and the top 3 secondary therapeutic indexes were body mass index(179 times),fasting blood glucose(175 times),and glycated hemoglobin(134 times).Conclusion:The study dissects the current status and trend of registration of clinical trials on traditional medicine for T2DM treatment.The number of trial registrations is on the rise year by year,and there are obvious geographical differences in the countries and platforms of registration.The trial design is mainly randomized controlled blind trials with a sample size of<100,and the main interventions are nonpharmacological therapies.Correct and standardized registration of clinical trials and timely reporting of study results are greatly important to facilitate the implementation of clinical trials,reduce publication bias,provide high-level diagnostic and therapeutic bases for clinical practice guidelines,and develop effective treatment strategies.This study is expected to help other scholars,health care professionals,patients,and the public to understand the latest research trends and hotspots in this field and provide certain references and inspirations for the future research design and clinical practice of traditional Chinese medicine in the treatment of T2DM.展开更多
文摘Introduction The mission of the WHO International Clinical Trials Registry Platform is to ensure that a complete view of research is accessible to all those involved in health care decision making. This will improve research transparency and will ultimately strengthen the validity and value of the scientific evidence base. The registration of all interventional trials is a scientific, ethical and moral responsibility.
文摘Objectives: Our aim was to clarify the study characteristics of countries that have registered clinical trials studies and to calculate the percentage of clinical trials that were registered in each country’s registry, and try to find and evaluate the factors determining that percentage. Design and Methods: The present study is a cross-sectional study using data from clinical trials registered from January 1, 2011, to December 31, 2015. Only countries with more than 2000 registered trials were included for further study. Ten countries met that criterion: United States, Japan, Iran, Australia, New Zealand, China, India, Germany, United Kingdom, and Netherland. The percentage of clinical trials that were registered in each country’s registry was calculated, and the factors determining that percentage were sought and analyzed through an exploratory approach. Results: The chi-squared test of independence indicated that the rate of clinical trial registration significantly differed between countries. From the adjusted standardized residuals, the percentage of clinical trials that were registered in the country of origin was higher in the United States, India, Japan, and Australia/New Zealand than in the European Union and China. Conclusion: The United States requires that informed consent documents for clinical trials contain clinical trial registration numbers from ClinicalTrials.gov, which could be the reason for the extremely high percentage of registered clinical trials (94%). Since the European Union does not have this requirement, clinical trials conducted in the European Union do not have to be registered in the countries in which they are conducted.
基金This work was supported by China Academy of Chinese Medical Sciences Innovation Fund(CI2021A05501)TCM Clinical Basic Discipline Innovation Team Project of China Academy of Chinese Medical Sciences Innovation Fund(CI2021B003)Basic Research Funds for Free Exploration Project of Institute of Basic Research in Clinical Medicine,China Academy of Chinese Medical Sciences(Z0856,Z0863,Z0855).
文摘Objective:To analyze clinical trials of traditional medicine(including Chinese herbal medicine and nonpharmacological therapies)for the treatment of type 2 diabetes mellitus(T2DM)registered in the International Clinical Trials Registry Platform(ICTRP),and accordingly to explore their clinical trial registration characteristics,development trend and intervention status,in an attempt to provide references for future research design,diagnosis and management of traditional Chinese medicine therapy for T2DM.Methods:The clinical trials related to Chinese herbal medicine and nonpharmacological therapies for treating T2DM were retrieved on the ICTRP online from the time of database construction to August 13,2023,to analyze the time of registration,country and institution of the study,source of funding,type and design of the study,randomization and blinding methods,clinical staging,therapeutic measures,and main therapeutic effect indexes.Descriptive statistical analysis was performed using R4.3.0 and Excel software.Results:A total of 774 clinical trials for T2DM treatment were included,of which 127 were traditional herbal therapies and 647 were nonpharmacological therapies.The T2DM clinical trial registration institutions were distributed in 50 countries worldwide involving 15 clinical registration platforms,with the most registrations in Iran,China,and Australia,and the top 3 registration platforms were the Iranian Clinical Trial Registry,the Australian New Zealand Clinical Trials Registry,and the ICTRP.Universities(551,71.19%)were the main funding sources.Intervention studies(750,96.90%)were the primary study type,including randomized controlled trials(432,56.4%),and 225 studies mentioned the blinding method.A total of 530(68.48%)with a sample size≤100 were included.Study phases were predominantly phase 2 and phase 3(108,51.43%).The interventions of traditional medicine for T2DM were composed of Chinese herbal medicines(mainly ginseng and astragalus compound),nonpharmacological therapies(mainly exercise and diet therapies),and 2 or more comprehensive treatment regimes.According to the type of study design,the first 3 main therapeutic indexes were fasting blood glucose(286 times),glycated hemoglobin(282 times),and insulin resistance(120 times),and the top 3 secondary therapeutic indexes were body mass index(179 times),fasting blood glucose(175 times),and glycated hemoglobin(134 times).Conclusion:The study dissects the current status and trend of registration of clinical trials on traditional medicine for T2DM treatment.The number of trial registrations is on the rise year by year,and there are obvious geographical differences in the countries and platforms of registration.The trial design is mainly randomized controlled blind trials with a sample size of<100,and the main interventions are nonpharmacological therapies.Correct and standardized registration of clinical trials and timely reporting of study results are greatly important to facilitate the implementation of clinical trials,reduce publication bias,provide high-level diagnostic and therapeutic bases for clinical practice guidelines,and develop effective treatment strategies.This study is expected to help other scholars,health care professionals,patients,and the public to understand the latest research trends and hotspots in this field and provide certain references and inspirations for the future research design and clinical practice of traditional Chinese medicine in the treatment of T2DM.
