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Russian clinical research policy does not guarantee results availability

World Journal of Meta-Analysis 2014年第4期2卷 154-161页

作者： Tatyana Arstakovna Shamliyan Anna Artemovna Avanesova Evidence-Based Medicine Center Clinical SolutionsPhiladelphiaPA 19103United States Stavropol State University Stavropol 355009Russian Federation

AIM： To investigate results availability from clinical studies enrolling Russian subjects and Russian clinical research ***： 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 *** 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 ***： 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 *** 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 ***： 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.

关键词： Clinical research Meta-analysis research standards Publication bias Medicine Legal

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