risk, management, strategic, communication, crisis


There is a first time for everything, including a crisis, which often comes unexpectedly and brings with it uncertainty and complexity. It rarely happens that politicians, government or managers are able to assess appropriately the impending danger, anticipate and take the necessary measures to avoid negative consequences. And it does not matter what kind of crisis it is: pandemic, financial and economic one, extreme weather events and associated natural disasters, or war. The crisis almost always contains unusual challenges and tasks, requires non-standard solutions. In addition, it is really important to act quickly. On the other hand, although any crisis has negative consequences, it often can cause the creating of the value for the society, can bring positive changes. Especially it concerns for the crises that continue for months or years. Such a crisis is changing and evolving all the time, and these are characterized by an abrupt development, there are spark and halt over the time. On the over hand, for the industry like clinical trials when the participation/adequate input of each stakeholder is obligatory, it is really necessary to develop overall strategy, ensure synchronicity of actions of all participants. Moreover, not all the stakeholders have direct link/communication among themselves, which adds a level of complexity into the resolution of the risk(s) under such circumstances. Any well-planned strategy cannot be successful without great motivation, clear instructions, good communication among all the parts, appropriate monitoring of the processes, the deliverables and the noncompliance with the following re-training, if necessary. It is fairly much relevant for Ukraine that is subjected to violence and aggression from Russia last 10 years. All group of the industry involved was not prepared for the disaster first, still started understanding, analyzing and reacting appropriately to constantly changing circumstances. That is why the purpose of the article is to research risk management strategies for the risks originating from modern crises, which make ineffective the traditional approaches, without paying attention to new non-traditional, constantly changing, unsustainable, sophisticated threats. At the same time, the purpose is to research new paradigms in multi-agency collaboration to resolve such challenges. The methods which are being used in this article are Empirical/Quantitative Researches, including Observation, Measurement and Comparison ones, Graphic images, outlines, tables have been provided to illustrate the logical sequence of the research. As a result of the study, the main risks affecting clinical trials in Ukraine due to the war and other events were established.


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Author Biography

Polad Amrakhov, "KROK" University

Clinical Project Manager, Cromos Pharma, Postgraduate student, "KROK" University, Kyiv, Ukraine


Basu S. (2017). Discussions on Standards for Risk Assessment and Safety Instrumented Systems. In S., Basu (Ed.). Plant Hazard Analysis and Safety Instrumentation Systems. pp. 385-466. Academic Press

Castañeda R. (2022, August 23). As Russia’s clinical trials sector falls, Ukraine rebuilds. Retrieved from: https://numl.org/NzX

Chorghay Z. (2022, Mar 01). Ukrainian Clinical Studies At Risk due to Russian Invasion. Retrieved from: https://numl.org/NzY

Dumenko T. (2020, Oct 8). Today’s clinical trials are treatment standards in the future. / Думенко Т. (2020, 8 жовтня). Клінічні випробування сьогодні – стандарти лікування в майбутньому. Retrieved from https://numl.org/NzZ [in Ukrainian]

How the Center resumes clinical trials in Ukraine in the conditions of Russian aggression: the results of the report. 2022, Nov 15. / Як Центр відновлює клінічні випробування в Україні в умовах російської агресії: результати звіту. 2022б 15 листопада. Retrieved from: https://numl.org/NA0 [in Ukrainian]

Information Report Regarding the Status of Clinical Trials in Ukraine in the Period from January 01, 2022 to August 31, 2022. 2022, Sept 21. Retrieved from: https://numl.org/NA1.

International council for harmonisation of technical requirements for pharmaceuticals for human use. (2017). Guideline for good clinical practice E6(R2). Step 5. June. Retrieved from: https://numl.org/NzV.

International council for harmonisation of technical requirements for pharmaceuticals for human use. (2006). ICH guideline Q9 on quality risk management Step 5. January. Retrieved from: https://numl.org/NA2.

Ivashchenko I. (2020, Oct 8). Prospects for improving clinical trials of medicinal products in Ukraine: current challenges and ways to overcome them. / Іващенко І. (2020, 8 жовтня). Перспективи вдосконалення клінічних випробувань лікарських засобів в Україні: сучасні виклики та шляхи їх подолання. Retrieved from: https://numl.org/NA3 [in Ukrainian]

John Carroll. (2005). CRO Crowing About Their Growth. Biotechnol Healthc. Dec, 2(6), 46-50.

Magdik I. (2020, Oct 8). Ukraine – unused potential. Retrieved from: https://www.dec.gov.ua/wp-content/uploads/Conference/2020/6/Plenary%20session/ps3.pdf

Recommendations from State Expert Center to Sponsors. 2022, March 14. Retrieved from: https://numl.org/NA4 [in Ukrainian]

Procedure for Conducting Clinical Trials of Medicinal Products and Expert Evaluation of Materials Pertinent to Clinical Trials and Model Regulations of the Ethics Committees approved by MoH Ukraine Order of 23.09.2009 № 690, registered at the Ministry of Justice of Ukraine on 29.10.2009 under № 1010/17026

Rubens D. (2015). Beyond ‘Command & Control’: Developing a New Paradigm for Incident Command Systems, Critical Decision-Making and 21st Century Crisis Response. 130 p.

Top 5 Challenges and Opportunities Drug Developers Face in Executing Clinical Trials. 2022, Dec 19. Retrieved from: www.ppd.com/blog/challenges-opportunities-in-clinical-trials.




How to Cite

Amrakhov, P. (2023). RISK MANAGEMENT ASPECTS, WAR AND FURTHER PERSPECTIVES IN CLINICAL TRIALS IN UKRAINE. Economics, Finance and Management Review, (1), 80–97. https://doi.org/10.36690/2674-5208-2023-1-80



Chapter 3. Modern management technologies