EVIDENCE CPR Publications

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Publications

Our Contribution to Evidence-based Medicine:

C. Paul J. Pockros, Eugene R. Schiff, Mitchell L. Shiffman, John G. McHutchison, Robert G. Gish, Nezam H. Afdhal, Manana Makhviladze, Mira Huyghe, David Hecht, Tilman Oltersdorf, and David A. Shapiro. Oral IDN-6556, an Antiapoptotic Caspase Inhibitor, May Lower Aminotransferase Activity in Patients with Chronic Hepatitis C. HEPATOLOGY 2007;46:324-329.
Patients in the Republic of Georgia were recruited through EVIDENCE (Los Altos, California and Tbilisi, Republic of Georgia)
Scirica BM, Morrow DA, Hod H, Murphy SA, Belardinelli L, Hedgepeth CM, Molhoek P, Verheugt FW, Gersh BJ, McCabe CH, Braunwald E. Effect of ranolazine, an antianginal agent with novel electrophysiological properties, on the incidence of arrhythmias in patients with non ST-segment elevation acute coronary syndrome: results from the Metabolic Efficiency With Ranolazine for Less Ischemia in Non ST-Elevation Acute Coronary Syndrome Thrombolysis in Myocardial Infarction 36 (MERLIN-TIMI 36) randomized controlled trial. Circulation. 2007 Oct 9;116(15):1647-52. Epub 2007 Sep 5.
Morrow DA, Scirica BM, Karwatowska-Prokopczuk E, Murphy SA, Budaj A, Varshavsky S, Wolff AA, Skene A, McCabe CH, Braunwald E; MERLIN-TIMI 36 Trial Investigators. Effects of ranolazine on recurrent cardiovascular events in patients with non-ST-elevation acute coronary syndromes: the MERLIN-TIMI 36 randomized trial. JAMA. 2007 Apr 25;297(16):1775-83.
Domanski M, Antman EM, McKinlay S, Varshavsky S, Platonov P, Assmann SF, Norman J. Geographic variability in patient characteristics, treatment and outcome in an International Trial of Magnesium in acute myocardial infarction. Control Clin Trials. 2004 Dec;25(6):553-62.
Aguilar D, Solomon SD, Kober L, Rouleau JL, Skali H, McMurray JJ, Francis GS, Henis M, O'Connor CM, Diaz R, Belenkov YN, Varshavsky S, Leimberger JD, Velazquez EJ, Califf RM, Pfeffer MA. Newly diagnosed and previously known diabetes mellitus and 1-year outcomes of acute myocardial infarction: the VALsartan In Acute myocardial iNfarcTion (VALIANT) trial. Circulation. 2004 Sep 21;110(12):1572-8. Epub 2004 Sep 13.
Chaitman BR, Pepine CJ, Parker JO, Skopal J, Chumakova G, Kuch J, Wang W, Skettino SL, Wolff AA; Combination Assessment of Ranolazine In Stable Angina (CARISA) Investigators. Effects of Ranolazine With Atenolol, Amlopidine, or Diltiazem on Excise Tolerance and Angina Frequency in Patients With Severe Chronic Angina. A Randomized Controlled Trial. JAMA, January 21, 2004 - Vol. 291, No 3, pp. 309-316.

You may download here a full list of publications before January, 2003 in PDF format.

Clinical Trials in Russia and Eastern Europe:

Since 1989, Western companies have been increasingly interested in Russia and Eastern European countries. While numerous multinational clinical studies have been conducted in Russia over the last 17 years, people unfamiliar with this work may have questions, such as: Is it true that recruitment rates in Russia are so high? Why do patients participate in clinical trials? How do companies handle local regulations? For answers to these and many other questions, please refer to the articles below.

Pyotr Platonov, MD, PhD. Agency Activity. Russian regulator seeks to certify all manufacturers for GMP by 2010. RAJ Pharma, November 2007, p 770-771.
Dmitry Reihart, MD, PhD, Pyotr Platonov, MD, PhD. Clinical trials in Russia: Growing experience and revision of regulations. Intl J Pharm Med 2005;19(2):73-76.
Dmitry Reihart, MD, PhD, Pyotr Platonov, MD, PhD. Clinical trial approval in Russia. RAJ Pharma, December 2004, p 871-872.
Pyotr Platonov, MD, PhD, Sergei Varshavsky, MD, PhD. FDA inspections Outside the USA: An Eastern European Perspective. Applied Clinical Trials, September 1, 2004 , p 60-64.
Pyotr Platonov, MD, PhD. Russian GMP Standard. EU-consistent standard comes into effect in 2005. RAJ Pharma, July 2004, p 538.
Pyotr Platonov, MD, PhD. GCP and GLP. New rules implemented. RAJ Pharma, November 2003, p 872.
Pyotr Platonov, MD, PhD, Sergei Varshavsky, MD, PhD, Rafael Escandon, PhD, MSc. Recruitment Rates and Data Quality - Are They Linked? Applied Clinical Trials, November 1, 2003, p 32-34.
Sergei Varshavsky, MD, PhD, Anna Ravdel, MBA, Pyotr Platonov, MD, PhD, Svetlana Timofeeva, MD, PhD, and Nadia Nurutdinov. Handling Clinical Trial Materials in Russia Pharmaceutical Manufacturing and Packing Sourcer, Autumn 2003 , p 82-86.
Pyotr Platonov, MD, PhD. Clinical trials in Russia and Eastern Europe: Recruitment and Quality International Journal of Clinical Pharmocology and Therapeutics, Vol 41 - No. 7/2003 (277-280).
Sergei Varshavsky, MD, PhD, Pyotr Platonov, MD, PhD, Maria Kistkina. Why do patients participate in trials? Good Clinical Practice Journal, Volume 9, Number 11, November 2002, p 11-14.
Elena Storozuk, MD, MS, and Sergei Varshavsky, MD, PhD. Dispelling the Myths Surrounding Clinical Trials in Russia PMPS Clinical Trials Supplies, Spring 2002, p 36-39.
Sergei Varshavsky, MD, PhD. Discover Russia for Conducting Clinical Research Applied Clinical Trials magazine, Volume 11, Number 3, March 2002, p 74-80.
Chapter Profile Highlights after Sergei Varshavsky, MD, PhD New Chapter Brings ACRP Message to Russia The Monitor, Spring 2002, Volume 16, Issue 1, P. 52.