Subjects in clinical trials, either patients with the target disease or healthy vohmteers, inevitably run a risk of injury or even death. To protect human subjects＇ rights to life and health, the Declaration of Helsi...Subjects in clinical trials, either patients with the target disease or healthy vohmteers, inevitably run a risk of injury or even death. To protect human subjects＇ rights to life and health, the Declaration of Helsinki has been developed as ＂a statement of ethical principles for medical research involving human subjects. Though widely regarded as a milestone in human research ethics, it is not a law or regulation, and is unable to effectively protect human subjects＇ rights. In this context, China beefs up its legal protection of clinical trial subjects.展开更多
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 ap...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.展开更多
基金funded by the National Social Science Foundation of China (Grant No.14BFX161)
文摘Subjects in clinical trials, either patients with the target disease or healthy vohmteers, inevitably run a risk of injury or even death. To protect human subjects＇ rights to life and health, the Declaration of Helsinki has been developed as ＂a statement of ethical principles for medical research involving human subjects. Though widely regarded as a milestone in human research ethics, it is not a law or regulation, and is unable to effectively protect human subjects＇ rights. In this context, China beefs up its legal protection of clinical trial subjects.
文摘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.
