Abstract
To organize and conduct a clinical trial (СT) at a high level, it is necessary to continuously monitor its quality, as the occurrence of non-conformances can threaten health and safety of the trial subjects, as well as lead to CT data loss or their unreliability. In general, for the effective CT quality control, it is expedient to continuously improve the quality management system of all parties who participate in the CT, including at the clinical site. Current regulatory requirements include an indication of the need for a continuous process of the quality management system improvement to ensure the proper level of the process performance, in particular, the system of non-conformances correction and prevention.The aim of this work was to evaluate the possibilities and problems of applying modern methods of risks correction and prevention in the CT quality management.Materials and methods. To achieve the aim of the study, a meta-analysis of literature sources using PICO search technology was carried out and analysis of existing regulatory documents on the availability of methodologies, instructions and algorithms for selecting and applying the non-conformances correction and prevention tools during CT organizing and conducting.Results of the study. The study showed that regulatory authorities see the need for standardized CT quality management systems to increase the number of qualified clinical sites, as well as more strict compliance with the ICH GCP principles. The analysis of regulatory documents showed the absence of unified harmonized requirements for carrying out the processes of correction and prevention of non-conformances within the framework of CT organizing and conducting.Conclusions.Organizing and conducting of CT requires continuous monitoring of the quality of the processes carried out to ensure getting of complete and reliable data on the study drug. Given the lack of regulatory requirements governing the process of non-conformances correction and prevention, it seems expedient to develop an algorithm for work with CAPA-plan and its methodology, as well as SOP to standardize the conduct of this process
Highlights
The ultimate goal of any clinical trial (CT) of a new drug is to obtain high-quality, integral and reliable data on the efficacy, safety and benefits of the developed drug
The non-conformances that may arise could be detected at different stages of CT: as a result of internal monitoring, monitoring by sponsor, inspections, audits, during the assessment of the trial subjects by study staff at the clinical site (CS), during data processing, analysis and synthesis, during CT quality control, as well as during regulatory inspections, audits
In the work of Munish Mehra et al it has been shown that a later discovery of non-conformances and, their later correction leads to an increase in the cost of conducting the trial in general [5]
Summary
The ultimate goal of any clinical trial (CT) of a new drug is to obtain high-quality, integral and reliable data on the efficacy, safety and benefits of the developed drug. In order to organize and conduct CT on a high level, it is necessary to continuously monitor its quality, as the occurrence of non-conformances can threaten the health and safety of the trial subjects, as well as lead to loss of data or their uncertainty [1, 2]. In the work of Munish Mehra et al it has been shown that a later discovery of non-conformances and, their later correction leads to an increase in the cost of conducting the trial in general [5]. In order to minimize the impact of the nonconformances on trial subjects safety and the integrity of the data and to prevent such non-conformances in the future, companies involved in the organization and conducting of CT must have a program for managing the conducted trial quality, as well as performing corrective and preventive actions [6]
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