Trials In Russia Research Articles

P.7.c.003 Atomoxetine in the treatment of psychostimulant-naive children and adolescents with ADHD: a 6-week, randomized, placebo-controlled trial in Russia

P.7.c.003 Atomoxetine in the treatment of psychostimulant-naive children and adolescents with ADHD: a 6-week, randomized, placebo-controlled trial in Russia

Clinical Trials in Russia

Clinical trials of pharmaceuticals have been running in Russia for more than ten years and while it is an attractive location for research, it remains a largely untapped resource as researchers look to expand patient recruitment outside the Western world.

Clinical trials in Russia and Eastern Europe: recruitment and quality.

To review the current situation of clinical trials in Russia and Eastern Europe. The volume of clinical trials in these territories is increasing. The quality of the data obtained, ethical care and compliance with Good Clinical Practice guidelines is at least as good as anywhere else. United States Food and Drug Administration inspection data indicate that sites in these countries are often superior to those elsewhere. Large-scale clinical trials conducted in these territories have been subsequently published in mainstream journals. Territory-specific attention must be paid to communications' equipment and language. However, this is countered, for example, by the fact that most clinical research associates in Russia hold degrees in medicine, that patients with previously untreated disease are more easily found than in North America or Western Europe, and the participation of large, purpose-built, healthcare institutions. Eastern Europe and Russia are well-established locales for clinical trials. These territories offer a solution to the competition for patients among clinical trials in North America or Western Europe.

Genotoxic Action of Cycloplatam, a New Platinum Antitumor Drug, on Mammalian Cells in vivo and in vitro

Cycloplatam (CP), a new antitumor platinum compound of the second generation, was first synthesized in Russia. This drug shows less toxicity in vivo than the widely used cisplatin and carboplatin and a higher antitumor activity than carboplatin. CP is not nephrotoxic with respect to the platinum-based antitumor agents. CP is actually studied in clinical phase II trials in Russia and Armenia. Promising results were obtained in patients with lung, ovary, and prostate cancers. The aim of this work was to study the micronuclei (MN) inducing effect of CP in vivo in murine bone marrow cells and in human lymphocytes in vitro. The mutagenic activity of CP in bone marrow of mice was significantly lower than that of cisplatin at equitoxic doses. In human lymphocytes CP induced a dose-dependent increase of MN, beginning at a very low dose (0.1 µM). Our results showed that CP is much less toxic and MN inducing in vivo in murine bone marrow than cisplatin. In vitro data evidenced that CP is more toxic and genotoxic to human cells than cisplatin. The evidence of a MN-induced activity of an antitumor drug suggests a potential risk for long-time survivors.

Conflict or harmony? Clinical research and the medical press in Russia.

The author relates conditions for conducting clinical trials in Russia, current experiences of ethics committees, areas where conflicts of interest can occur regarding publishing the results of clinical trials in medical journals and the state of medical journalism in Russia today.

How to conduct a quality clinical trial in Russia? A few useful tips

What does a project manager mean by the term ‘quality clinical trial’? There is no universally acceptable definition, but to a project manager, a quality clinical trial means a well-designed trial that is performed in full compliance with GCP, study protocol and company procedures, within budget and on time. Obviously, the study has to be quality assured for the data to be reliable. Conducting a quality study in Russia is as challenging as it is anywhere else. A lot has been published to date on how to achieve quality in drug development regardless of the country where the research is conducted. Since necessary practical skills tend to differ more or less from country to country, the purpose of this paper is to present a close-up view of certain practical issues associated with carrying out clinical trials to international standards in Russia. © 1997 John Wiley & Sons, Ltd.

How to conduct a quality clinical trial in Russia? A few useful tips

What does a project manager mean by the term ‘quality clinical trial’? There is no universally acceptable definition, but to a project manager, a quality clinical trial means a well-designed trial that is performed in full compliance with GCP, study protocol and company procedures, within budget and on time. Obviously, the study has to be quality assured for the data to be reliable. Conducting a quality study in Russia is as challenging as it is anywhere else. A lot has been published to date on how to achieve quality in drug development regardless of the country where the research is conducted. Since necessary practical skills tend to differ more or less from country to country, the purpose of this paper is to present a close-up view of certain practical issues associated with carrying out clinical trials to international standards in Russia. © 1997 John Wiley & Sons, Ltd.

Clean-up of urban areas in the CIS countries contaminated by Chernobyl fallout

Earlier investigations in the CIS (the former Soviet Union) showed that the radiation from urban surfaces contaminated by Chernobyl fallout was almost entirely due to 137Cs. Following a series of small-scale tests, several decontamination methods were selected for field trials in Russia and Ukraine. The trials revealed that, even after 7 years, up to 75% of the 137Cs could be removed at relatively little cost and more could be removed if necessary.

Implementation of international standards in clinical trials in Russia

Here we describe fatal pulmonary cysticercosis caused by Cysticercus longicollis, the larval stage of Taenia crassiceps in a 15-year-old female ring-tailed lemur (Lemur catta) from Sarajevo Zoo. After sudden death, the lemur was subjected to necropsy and large multicystic structure, subdivided with fibrous septa and filled with numerous translucent, oval to ellipsoid bladder-like cysts (cysticerci), almost completely replacing right lung lobe was observed. In addition, numerous free and encysted cysticerci were found in the thoracic cavity. Histopathology revealed connective tissue outlined cavities that compress lung parenchyma. Each cavity contained several thin walled cysticerci with single inverted protoscolex, one or more suckers and rostelum with two rows of hooks. In many of the cysticerci one or several exogenous buds of daughter cysticerci were observed. Based on morphology and microscopic appearance the parasite was identified as C. longicollis. Subsequent molecular analysis and sequencing confirmed presumptive diagnosis. To our knowledge, this case represents the first report of T. crassiceps and cysticercosis caused by C. longicollis in Bosnia and Herzegovina.

Use of the genetic engineering growth hormone SAISEN in children with somatotropic insufficiency: Results of clinical trials in Russia

The efficacy and safety of SAISEN, a recombinant human growtn hormone obtained from mammalian cells, was tested in children with hypophyseal nanism. The treatment duration was 1 year. The results indicate that SAISEN (ARES-SERONO) is a highly effective and safe preparation of growth hormone, noticeblly stimulating the growth rate both in previously untreated children with somatotropic insufficiency, and in those previously treated with STII preparations. Therapy with SAISEN was not associated with any side effects, as shown by both clinical and laboratory data.

Faith on Trial in Russia. By Michael Bourdeaux. New York: Harper and Row, 1971. 192 pp. $5.95

Faith on Trial in Russia. By Michael Bourdeaux. New York: Harper and Row, 1971. 192 pp. $5.95 Albert W. Wardin, Jr. Albert W. Wardin, Jr. Search for other works by this author on: Oxford Academic Google Scholar Journal of Church and State, Volume 16, Issue 1, Winter 1974, Pages 146–147, https://doi.org/10.1093/jcs/16.1.146 Published: 01 January 1974

Faith on Trial in Russia

Faith on Trial in Russia

Diesel Traction

The author points out the difficulty in designing steam locomotives of high overall efficiency, no matter to what type they may belong, and shows that the efficiency of Diesel locomotives is considerably higher, while they also possess certain other advantages, particularly in bringing about a reduction in permanent way maintenance costs. Early Diesel locomotives are described and an account is given of the collaboration between the German and Russian railways, to investigate various types of transmission, and of the transportable locomotive laboratory which was built for carrying out the necessary tests. The economic aspect of railway operation is carefully analysed, and the results of extended trials in Russia of steam, Diesel-electric, and Diesel geared locomotives are given and compared with the latest available figures for operating costs in this country, and with figures for sparsely populated regions in Asia. The author, while not advocating wholesale adoption of Diesel locomotives everywhere, arrives at the conclusion that they have a definite sphere of usefulness, particularly in regions where water is scarce or of bad quality. He also emphasizes the necessity for standardized types of Diesel locomotives, and suggests that owing to the inherent drawbacks in the transmissions both of the Diesel-electric and Diesel geared types, there may be a future for the Diesel locomotive with direct drive with an enlarged engine, provided that, by research and experimental work, the difficulties previously encountered with direct drive can be removed. The author also notes that from the point of view of fuel consumption and simplicity the speed of the Diesel engine and the number of cylinders should not exceed certain limits.

Capitalism on Trial in Russia

Capitalism on Trial in Russia