Russian clinical research policy does not guarantee results availability
Russian clinical research policy does not guarantee results availability作者机构:Evidence-Based Medicine CenterClinical SolutionsPhiladelphiaPA 19103United States Stavropol State UniversityStavropol 355009Russian Federation
出 版 物:《World Journal of Meta-Analysis》 (世界荟萃分析杂志)
年 卷 期:2014年第2卷第4期
页 面:154-161页
学科分类:12[管理学] 1204[管理学-公共管理] 120402[管理学-社会医学与卫生事业管理(可授管理学、医学学位)] 1004[医学-公共卫生与预防医学(可授医学、理学学位)] 10[医学]
主 题:Clinical Research Meta-analysis Research standards Publication bias Medicine Legal
摘 要: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.