Russian clinical research policy does not guarantee results availability

来源 :World Journal of Meta-Analysis | 被引量 : 0次 | 上传用户:
下载到本地 , 更方便阅读
声明 : 本文档内容版权归属内容提供方 , 如果您对本文有版权争议 , 可与客服联系进行内容授权或下架
论文部分内容阅读
AIM: To investigate results availability from clinical studies enrolling Russian subjects and Russian clinical research policy.METHODS: We analyzed Russian legislation and ethical regulations about drug and devices approval,clinical research registration and the results availability.In August 2012,we searched International Clinical Trials Registry Platform and clinicaltrials.gov to find all registered studies that had an investigational site in the territory of the Russian Federation.To find publication status,we searched the Pub Med and Scirus bibliographical databases with trial registration number to find journal publications of the registered studies.RESULTS: We identified 2062 registered research protocols comprising 2017 international and 45 protocols sponsored by the Russian funding agencies.The number of the studies enrolling Russian subjects increased dramatically from three studies in 2002 to 252 studies in 2012.Most studies(92%) were funded exclusively by industry,were interventions(94.6%),examined drugs(87%) and enrolled exclusively adults(86%) of both genders(89%).Only 383(19%) of multinational studies and two(4.4%) of exclusively Russian studies werepublished.Posting of patient outcomes was available for 16% of the trials that recruited trial participants in the Russian territory including one study funded exclusively by Russian sponsors.Investigators terminated 99 studies of 38111 participants and did not provide the results in clinicaltrials.gov or in published manuscripts.Federal laws require clinical study registration and conflict of interest disclosure.However,routine monitoring of compliance to clinical research policy is not available.CONCLUSION: Russian legislation does not guarantee the availability of clinical research results.Russian legislation should mandate transparent evidence- based market approval of the drugs and devices. AIM: To investigate results availability from clinical studies enrolling Russian subjects and Russian clinical research policy. METHODS: We analyzed Russian legislation and ethical regulations about drug and devices approval, clinical research registration and the results availability. In August 2012, we searched International Clinical Trials Registry Platform and clinicaltrials.gov to find all registered studies that had an investigational site in the territory of the Russian Federation. To find publication status, we searched the Pub Med and Scirus bibliographical databases with trial registration number to find journal publications of the registered studies .RESULTS: We identified 2062 registered research protocols including 2017 international and 45 protocols sponsored by the Russian funding agencies. The number of the studies enrolling Russian titles increased dramatically from three studies in 2002 to 252 studies in 2012.Most studies (92%) were funded exclusively by industry, were inter Only 383 (19%) of multinational studies and two (4.4%) of exclusively Russian studies were publishes .Posting (94.6%), examined drugs (87%) and enrolled exclusively adults (86%) of both genders of patient outcomes was available for 16% of the trials that recruited trial participants in the Russian territory including one study provided exclusively by Russian sponsors. Investigators terminated 99 studies of 38111 participants and did not provide the results in clinicaltrials.gov or in published manuscripts. Federal laws require clinical study registration and conflict of interest disclosure. Yet, routine monitoring of compliance to clinical research policy is not available. CONCLUSION: Russian legislation does not guarantee the availability of clinical research results. Russian legislation should mandate transparent evidence- based market approval of the drugs and devices.
其他文献
期刊
本文通过对荣华二采区10
期刊
为庆祝中国性学会成立20周年,本着节俭的精神,10月18曰在北京大学医学部举办了小型座谈会。学会现任领导及老领导、顾问、理事代表、秘书处工作人员以及《中国性科学》杂志社
请下载后查看,本文暂不支持在线获取查看简介。 Please download to view, this article does not support online access to view profile.
期刊
目的:探讨代谢综合征(metabolicsyndrome,MS)患者血清瘦素(leptin)水平与血脂、肥胖和胰岛素抵抗的关系。方法:60例MS患者和28名年龄相匹配的正常对照者,按体重指数(BMI)将MS
请下载后查看,本文暂不支持在线获取查看简介。 Please download to view, this article does not support online access to view profile.
期刊
有研究表明,人们身上的许多习惯会对健康产生一定的影响,人们日复一日所做的事情,可以决定他们自身的年龄,比如众所周知的:不抽烟、多运动、保持血压在120/80毫米汞柱以下等
Elecsys - 1 0 1 0型全自动电化学发光免疫分析系统由瑞士罗氏公司于 1 997年推出。该系统采用先进的电化学发光技术 ,将电化学和免疫测定相结合 ,具有超高的测定灵敏度和线
期刊
针对采用电子镇流器的荧光灯具及采用HID光源和电感镇流器的灯具,介绍了灯具设计过程中在电学和热学方面需考虑的几个问题。