Published online Nov 26, 2014. doi: 10.13105/wjma.v2.i4.154
Revised: August 11, 2014
Accepted: September 4, 2014
Published online: November 26, 2014
Processing time: 202 Days and 11.6 Hours
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 PubMed 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 were published. 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.
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.