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
目的全面检索国内外母方案设计的相关研究,了解其临床应用所覆盖的研究领域,为国内护理人员开展母方案设计相关研究的实施和推广提供参考。方法采用Arksey和O’Malley提出的范围综述方法,系统检索中国知网、万方数据库、中国生物医学文...目的全面检索国内外母方案设计的相关研究,了解其临床应用所覆盖的研究领域,为国内护理人员开展母方案设计相关研究的实施和推广提供参考。方法采用Arksey和O’Malley提出的范围综述方法,系统检索中国知网、万方数据库、中国生物医学文献数据库、维普、PubMed、Cochrane Library、Embase、Web of Science,检索时限为从建库至2023年4月。根据纳入、排除标准筛选文献,2名研究者独立提取母方案设计核心要素及其应用领域相关资料,采用描述性分析及主题分析法对提取结果进行整理。结果共纳入104篇文献,研究领域涉及肿瘤、临床心理学、新型冠状病毒肺炎等的药物开发评估及个性化健康计划的制定。母方案在国内外应用存在着明显差异,主要体现在3个方面:(1)应用范围不同,国外主要用于评估新药、疗法或医学器材的有效性和安全性,而在我国广泛应用于中医药领域;(2)研究类型有别,国外主要应用多中心随机对照试验、队列研究,而我国此类型研究相对较少;(3)经验和技术支持方面,由于历史和文化背景等原因,国外研究者在母方案的设计和实施方面拥有更丰富的经验和技术支持。因此,在推广和应用母方案时,需充分考虑国内外的差异,并结合本土实际情况探索出适合自身条件下的研究模式和方法,以推进其更广泛和深入的应用。结论母方案的实施是临床研究模式的一次突破性创新,当前母方案设计的应用多集中在肿瘤学、新型冠状病毒肺炎领域,但伞式试验和篮式试验可用于健康领域,平台试验的范围可应用于临床心理学和数字心理健康干预,国内护理研究者应重视对母方案设计的应用,在其指导下开展相关研究,提升护士创新行为,积极寻找新方法和技术,循证优化试验设计,解决临床护理问题,快速适应精准医学的发展。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.
文摘目的全面检索国内外母方案设计的相关研究,了解其临床应用所覆盖的研究领域,为国内护理人员开展母方案设计相关研究的实施和推广提供参考。方法采用Arksey和O’Malley提出的范围综述方法,系统检索中国知网、万方数据库、中国生物医学文献数据库、维普、PubMed、Cochrane Library、Embase、Web of Science,检索时限为从建库至2023年4月。根据纳入、排除标准筛选文献,2名研究者独立提取母方案设计核心要素及其应用领域相关资料,采用描述性分析及主题分析法对提取结果进行整理。结果共纳入104篇文献,研究领域涉及肿瘤、临床心理学、新型冠状病毒肺炎等的药物开发评估及个性化健康计划的制定。母方案在国内外应用存在着明显差异,主要体现在3个方面:(1)应用范围不同,国外主要用于评估新药、疗法或医学器材的有效性和安全性,而在我国广泛应用于中医药领域;(2)研究类型有别,国外主要应用多中心随机对照试验、队列研究,而我国此类型研究相对较少;(3)经验和技术支持方面,由于历史和文化背景等原因,国外研究者在母方案的设计和实施方面拥有更丰富的经验和技术支持。因此,在推广和应用母方案时,需充分考虑国内外的差异,并结合本土实际情况探索出适合自身条件下的研究模式和方法,以推进其更广泛和深入的应用。结论母方案的实施是临床研究模式的一次突破性创新,当前母方案设计的应用多集中在肿瘤学、新型冠状病毒肺炎领域,但伞式试验和篮式试验可用于健康领域,平台试验的范围可应用于临床心理学和数字心理健康干预,国内护理研究者应重视对母方案设计的应用,在其指导下开展相关研究,提升护士创新行为,积极寻找新方法和技术,循证优化试验设计,解决临床护理问题,快速适应精准医学的发展。
