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World J Meta-Anal. Nov 26, 2014; 2(4): 154-161
Published online Nov 26, 2014. doi: 10.13105/wjma.v2.i4.154
Published online Nov 26, 2014. doi: 10.13105/wjma.v2.i4.154
Russian clinical research policy does not guarantee results availability
Tatyana Arstakovna Shamliyan, Evidence-Based Medicine Center, Clinical Solutions, Philadelphia, PA 19103, United States
Anna Artemovna Avanesova, Stavropol State University, Stavropol 355009, Russian Federation
Author contributions: Shamliyan TA and Avanesova AA solely contributed to this paper.
Correspondence to: Tatyana Arstakovna Shamliyan, MD, MS, Senior Director, Quality Assurance, Evidence-Based Medicine Center, Clinical Solutions, Elsevier, 1600 JFK Blvd, Philadelphia, PA 9103, United States. t.shamliyan@elsevier.com
Telephone: +1-215-2393821-3821 Fax: +1-215-2396114
Received: May 14, 2014
Revised: August 11, 2014
Accepted: September 4, 2014
Published online: November 26, 2014
Processing time: 202 Days and 11.6 Hours
Revised: August 11, 2014
Accepted: September 4, 2014
Published online: November 26, 2014
Processing time: 202 Days and 11.6 Hours
Core Tip
Core tip: We identified clinical studies that enrolled Russian subjects and found very low rate of the publication of the results in peer reviewed clinical journals or posting of the results in trial registry, clinicaltrials.gov. We concluded that Russian legislation does not guarantee the availability of clinical research results. The Russian legislation should be revised to mandate transparent evidence- based market approval of the drugs and devices based on high quality clinical evidence applicable to the Russian population.