摘要
AIM： To investigate results availability from clinical studies enrolling Russian subjects and Russian clinical research policy.METHODS： We analyzed Russian legislation and ethi-cal regulations about drug and devices approval, clini-cal research registration and the results availability. In August 2012, we searched International Clinical Trials Registry Platform and clinicaltrials.gov to fnd all regis-tered studies that had an investigational site in the ter-ritory of the Russian Federation. To fnd publication sta-tus, we searched the PubMed and Scirus bibliographical databases with trial registration number to fnd journal publications of the registered studies.RESULTS： We identifed 2062 registered research pro-tocols comprising 2017 international and 45 protocols sponsored by the Russian funding agencies. The num-ber 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 stud-ies 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 exclu-sively 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 con-fict 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 leg-islation 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 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.
