RESEARCH INVOLVING HUMAN SUBJECTS IN UKRAINE: HOW TO LEVERAGE ARISING OPPORTUNITIES?

Andriy  Cherkas

doi:10.25040/ntsh2021.01.02

Andriy Cherkas Team Early Projects Type 1 Diabetes, Therapeutic Area Diabetes and Cardiovascular Medicine, Research & Development, Sanofi-Aventis-Deutschland GmbH., Frankfurt-am-Main, Germany https://orcid.org/0000-0002-6652-6983

DOI: https://doi.org/10.25040/ntsh2021.01.02

Keywords: good clinical practice, clinical research, human subjects, application for funding, National Research Foundation of Ukraine

Abstract

The review of the applications for grants of the National Research Foundation of Ukraine revealed evidence that many applicants-clinicians are not aware of the principles of Good Clinical Practice (GCP) that are implemented in different forms in the vast majority of research involving human subjects across the globe. In the essay, based on the experience of researching at Danylo Halytsky Lviv National Medical University (Ukraine), Loma Linda University (USA), Friedrich Schiller University Jena (Germany), as well as industry (Sanofi-Aventis-Deutschland GmbH., Frankfurt am Main, Germany), the author shares his thoughts about the gaps in education, training, regulations and administrative flaws that prevent more rapid progress in clinical research in Ukraine. Despite the complexity of the problem, implementation of relatively simple steps at institutional and/or national levels, as suggested, can boost the efficiency of research, increase the quality of applications and move clinical research in Ukraine to a qualitatively different level

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References

Vijayananthan A, Nawawi O. The importance of Good Clinical Practice guidelines and its role in clinical trials. Biomed Imaging Interv J. 2008;4(1):e5.

https://doi.org/10.2349/biij.4.1.e5

Guideline IHTJJPM. Guideline for good clinical practice. 2001;47(3):199-203.

Otte A, Maier-Lenz H, Dierckx RA. Good clinical practice: historical background and key aspects. Nucl Med Commun. 2005;26(7):563-74.

https://doi.org/10.1097/01.mnm.0000168408.03133.e3

Dixon JRJQA. The international conference on harmonization good clinical practice guideline. 1999;6(2):65-74.

https://doi.org/10.1080/105294199277860

Grimes DA, Hubacher D, Nanda K, Schulz KF, Moher D, Altman DG. The Good Clinical Practice guideline: a bronze standard for clinical research. Lancet. 2005;366(9480):172-4.

https://doi.org/10.1016/S0140-6736(05)66875-4

Mentz RJ, Hernandez AF, Berdan LG, Rorick T, O'Brien EC, Ibarra JC, et al. Good Clinical Practice Guidance and Pragmatic Clinical Trials: Balancing the Best of Both Worlds. Circulation. 2016;133(9):872-80.

https://doi.org/10.1161/CIRCULATIONAHA.115.019902

Cherkas A, Eckl P, Gueraud F, Abrahamovych O, Serhiyenko V, Yatskevych O, et al. Helicobacter pylori in sedentary men is linked to higher heart rate, sympathetic activity, and insulin resistance but not inflammation or oxidative stress. Croat Med J. 2016;57(2):141-9.

https://doi.org/10.3325/cmj.2016.57.141

Cherkas A, Golota S, Gueraud F, Abrahamovych O, Pichler C, Nersesyan A, et al. A Helicobacter pylori-associated insulin resistance in asymptomatic sedentary young men does not correlate with inflammatory markers and urine levels of 8-iso-PGF2-alpha or 1,4-dihydroxynonane mercapturic acid. Arch Physiol Biochem. 2018;124(3):275-85.

https://doi.org/10.1080/13813455.2017.1396346

Cherkas A, Zarkovic K, Cipak Gasparovic A, Jaganjac M, Milkovic L, Abrahamovych O, et al. Amaranth oil reduces accumulation of 4-hydroxynonenal-histidine adducts in gastric mucosa and improves heart rate variability in duodenal peptic ulcer patients undergoing Helicobacter pylori eradication. Free Radic Res. 2018;52(2):135-49.

https://doi.org/10.1080/10715762.2017.1418981

Holota S, Komykhov S, Sysak S, et al. Synthesis, Characterization and In Vitro Evaluation of Novel 5-Ene-thiazolo[3,2-b][1,2,4]triazole-6(5H)-ones as Possible Anticancer Agents. Molecules. 2021; 26(4):1162. https://doi.org/10.3390/molecules26041162.