The analysis of specialists’ opinion on the implementation of concept of risk management in clinical trials of drugs
DOI:
https://doi.org/10.14739/2310-1210.2016.3.77004Keywords:
Сlinical Trials, Drug Evaluation, Risk Assessment, 4-drugs, InvestigationalAbstract
At the modern stage of the pharmaceutical industry development quality risk management becomes an integral part of all the processes of drug development and clinical trials (CT).
Aim of paper is to study the opinion of competent experts in the field of CT of drugs and formation of strategic ways of risk management at the clinical site as well as to identify possible complications in the practical implementation of these approaches.
Materials and methods: the survey of the expert group (17 people) to select the indicators and the parameters measuring the risks of CT at clinical site, as well as their acceptable levels. The assessment of survey results was done using non-parametric statistics methods.
Results of research. There were established the differences of various stakeholders’ notion of conceptual content and practical importance of quality management and the application of risk-oriented approaches at the clinical site in relation to CT quality that can become an obstacle to their implementation. The introduction of risk-based monitoring into the system for CT management at the clinical site corresponds to the interests of all stakeholders involved in the study. General concernment of the customer’s representatives, regulatory authority and researchers should be an important basis for the implementation of the risk-based management at the clinical site. So, it is necessary to create a common understanding of the terminology, objectives and expected outcomes of risk management at the clinical site, as well as a clear allocation of the duties and responsibilities of each side.
Conclusions. The expediency of the concept of risk management application at the clinical site, practical orientation, as well as the need to develop scientific and methodological approaches for its implementation, contributing to the formation of a common basis for action and coordinated interaction of stakeholders involved in the management of CT were proved.
References
Zupanets, K. O., Dobrova, V. E., & Proskurnya, E. M. (2015). Naukove obgruntuvannia intehrovanoi systemy upravlinnia klinichnym vyprobuvanniam likarskykh zasobiv na mistsi provedennia doslidzhennia [Science justification of combined management system of clinical trial of drugs on clinical site]. Upravlinnia, ekonomika ta zabezpechennia yakosti v farmatsii, 4(42), 60–66 [in Ukrainian].
Zupanets, K. O., & Dobrova, V. E. (2015). Kontseptualni polozhennia shchodo upravlinnia ryzykamy u klinichnomu vyprobuvanni likarskykh zasobiv na mistsi provedennia doslidzhennia [Conceptual conditions of risk-based quality management in clinical trial at study site]. Upravlinnia, ekonomika ta zabezpechennia yakosti v farmatsii, 6(44), 49–57 [in Ukrainian].
(2009). Likarski zasoby. Nalezhna klinichna praktyka: nastanova ST-NMOZU 42-7.0:2008 [The drugs. Good Clinical Practice: Guideline ST-NMoHU]. Кyiv: Моrіоn [in Ukrainian].
(2009) Nakaz Ministerstva okhorony zdorovia Ukrainy «Pro zatverdzhennia Poriadku provedennia klinichnykh vyprobuvan likarskykh zasobiv ta ekspertyzy materialiv klinichnykh vyprobuvan i Typovoho polozhennia pro komisii z pytan etyky» vid 23.09.2009 p. №690 (zi zminamy, vnesenymy zghidno z nakazamy №523 vid 12.07.2012 p., №304 vid 06.05.2014 p., №966 vid 18.12.2014 p.) [The oder of Ministry of health of Ukraine «On approval of course of the drugs clinical trials conducting and of clinical trials materials expertise and the typal statement about research ethics committees»]. Retrieved from http://zakon5.rada.gov.ua/laws/show/z1010-09 [in Ukrainian].
International Conference оn Harmonisation оf Technical Requirements for Registration оf Pharmaceuticals for Human Use (2008). Guideline for Good Clinical Practice. ICH Topic E 6 (R1).
Postnikov, V. M. (2012). Analiz podkhodov k formirovaniyu sostava e´kspertnoj grupy, orientirovannoj na podgotovky i prinyatie reshenij [Analyzes of approaches to organization of expert’s group structure, which is oriented on preparation and adoption of decisions]. Nauka i obrazovanie, 5, 333–346 [in Russian].
Mikhnenko, P. (2007). Sekrety e´ffektivnykh biznes-reshenij [Secrets of effective business-decisions]. Moscow: NT Press [in Russian].
(2015). International Conference on Harmonisation. Integrated Addendum to ICH E6(R1): Guideline for Good Clinical Practice E6(R2). Retrieved from http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E6/E6_R2__Addendum_Step2.pdf.
Huppler, Hullsiek K., et al. (2015) Investigating the Efficacy of Clinical Trial Monitoring Strategies: Design and Implementation of the Cluster Randomized START Monitoring Substudy. Therapeutic Innovation & Regulatory Science, 49(2), 225–233.
Downloads
How to Cite
Issue
Section
License
Authors who publish with this journal agree to the following terms:
- Authors retain copyright and grant the journal right of first publication with the work simultaneously licensed under a Creative Commons Attribution License that allows others to share the work with an acknowledgement of the work's authorship and initial publication in this journal.
- Authors are able to enter into separate, additional contractual arrangements for the non-exclusive distribution of the journal's published version of the work (e.g., post it to an institutional repository or publish it in a book), with an acknowledgement of its initial publication in this journal.
- Authors are permitted and encouraged to post their work online (e.g., in institutional repositories or on their website) prior to and during the submission process, as it can lead to productive exchanges, as well as earlier and greater citation of published work (See The Effect of Open Access)