Theory and practice of clinical trials in oncology and hematology
https://doi.org/10.17650/1818-8346-2016-11-2-52-59
Abstract
In the era of evidence-based medicine the main reason for the implementation of new treatment methods are the results of clinical trials. However, clinical trials is a separate area of knowledge, which is often little known to clinicians, that does not allow them to adequately interpret the results of studies. The article describes the basic principles for the conduct and interpretation of clinical trials in hematology and oncology.
About the Author
N. V. Zhukov
Federal Research Center of Pediatric Hematology, Oncology and Immunology named after Dmitry Rogachev; 1 Samory Mashela str., Moscow, 117997, Russia;
Pirogov Russian National Research Medical University; 1 Ostrovitianov str., Moscow, 117997, Russia
Russian Federation
Russian Federation
References
1. Friedman L. M., Furberg C. D., DeMets D. L. Fundamentals of Clinical Trials, 4th ed. 2010. New York, NY: Springer Science + Business Media, LLC.
2. Streiner D. L., Norman G. R. Drug Trial Phases. Community Oncology. 2009;6(1): 36–40.
3. Наглядная медицинская статистика: учеб. пособие. А. Петри, К. Сэбин; пер. с англ. под ред. В. П. Леонова. 3-е изд., перераб. и доп. М.: ГЭОТАР-Медиа, 2015. 216 с.
4. Including Clinical Trials in Your Practice – National Cancer Institute, http://www. cancer.gov/resources-for/hp/education/including-clinical-trials-course. pdf
5. Schilsky Richard L. Oncology Clinical Trials: Successful Design, Conduct and Analysis. Ed. Susan Halabi. Demos Medical Publishing, 2009.
6. Guideline on Evaluation of Anticancer Medicinal Products in Man (рекомендации Европейского медицинского агентства, EMA), http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2013/01/ WC500137128. pdf.
Review
For citations:
Zhukov N.V. Theory and practice of clinical trials in oncology and hematology. Oncohematology. 2016;11(2):52-59. (In Russ.) https://doi.org/10.17650/1818-8346-2016-11-2-52-59
Views:
9711
Email this article 