REMEDIUMREMEDIUM1561-59362658-3534Joint-Stock Company Chicot107210.21518/1561-5936-2019-4-36-43Original ArticleNon-adherence as the reason for unreliable result s of a clinical studyMELIKHOVO. G.-TATARENKOA. O.-Institute of Clinical Trials041220194445018032022Copyright © 2019,2019The article describes sources of drug non-compliance in clinical trials and methods of assessment of compliance. Protocol violations in terms on non-adherence to study treatment and their effect on study results and on costs of drug development are discussed. Sample size calculation considering possible non-compliance and protocol deviations presented.clinical studiesclinical researchclinical trialsdrug compliancestudy treatment adherencequality of datareliability of dataклинические исследованиясоблюдение режима приема исследуемого препаратадостоверность данных1.National Council on Patient Information and Education, Prescription Medicine Compliance: a review of the baseline of knowledge, August 1995. Medication Regimens: causes of noncompliance. Office of Inspector General, U.S. Department of Health and Human Services; March 1990.2.National Community Pharmacists Association. National Report Card on Adherence, 2013.3.Scheen A.J., Giet D. Non compliance to medical therapy; causes, consequences, solutions. Rev Med Liege. 2010 May-Jun;65(5-6):239-45.4.Adherence to Long-Term Therapies. Evidence for action. World Health Organization, 2003.5.Сахарный диабет: острые и хронические осложнения. Под ред. Дедова И.И., Шестаковой М.В. Медицинское информационное агентство. М., 2011. УДК 616,379-008.64.6.Liebl A. et al. Costs of type 2 diabetes in Germany. Results of the CODE-2 study. Deutsche Medizinische Wochenschrift, 2001;126:585-589.7.Waeber B., Burnier M., Brunner H.R. How to improve adherence with pre- scribed treatment in hypertensive patients? Journal of Cardiovascular Pharmacology. 2000;35(Suppl 3):S23-S26.8.The sixth report of the joint national committee on prevention, detection, evaluation, and treatment of high blood pressure. Bethesda M.D., National High Blood Pressure Education Program, National Heart, Lung, and Blood Institute, National Institutes of Health. 1997.9.Horwitz R.I., Viscoli C.M., Berkman L. Treatment adherence and risk of death after a myocardial infarction. Lancet. 1990;336:542-545.10.Alsumidaie M. Non-Adherence: A Direct Influence on Clinical Trial Duration and Cost. Applied Clinical Trials, Apr 24, 2017. http://www.appliedclinicaltrialsonline.com/non-adherence-direct-influence-clinical-trial-duration-and-cost.11.Czobor P., Skolnick P. The Secrets of a Successful Clinical Trial: Compliance, Compliance and Compliance. Molecular Interventions. 2011 April;11(2):107-110.12.Morisky D.E., Green L.W., Levine D.M. Concurrent and predictive validity of a self-reported measure of medication adherence. Med Care. 1986 Jan;24(1):67-74.13.Alsumidaie M. Technology Tips on Improving Clinical Trial Patient Adherence. Applied Clinical Trials, Feb 13, 2015. http://www.appliedclinicaltrialsonline.com/technology-tips-improving-clinical-trial-patient-adherence.14.Dorothy L. Smith. Patient Nonadherence in Clinical Trials: Could There Be a Link to Postmarketing Patient Safety? Drug Information Journal. 2012;46(1):27-43.15.Bland M. An Introduction to Medical Statistics, 3rd.ed. Oxford University Press, Oxford, 2000:335-347.