INTRODUCTION:

Currently, one of the main areas of the educational policy of higher pharmaceutical education is the formation of a graduate researcher to create advanced technologies in the field of life sciences^1-6. The optimal conceptual basis for the management of students' research activities is the project-based approach^7-10. In Russia, the regulatory framework for project management is based on the Project Management Institute (PMI) methodology in the Project Management Body of Knowledge (PMBOK)-6 format^{11, 12}.

The main components of this methodology are the management and subject processes of the project, the areas of knowledge on project management, and the project lifecycle^{13, 14}. The project lifecycle is understood as a set of sequential phases through which the project passes from the moment of its beginning to completion^15-17. The scientific literature presents materials on the possible application of the project lifecycle in the research activities of students^18-20.

As for the application of projects in pharmaceutical education, the work²¹ substantiates the use of the project-based method in the training of future pharmacists and presents projects aimed at teaching the implementation of standard procedures in pharmaceutical consulting. Studies^{22, 23} show the insufficiency of the project-based method in Russian pharmaceutical education in comparison with the leading pharmaceutical universities in the world, which reduces the competitive advantages of graduates.

The paper²⁴ presents the development of a research program that uses the method of project-based and modular teaching (PMBT) and concludes that PMBT experiments by conducting research projects (RP) contribute to students gaining in-depth knowledge of the basics of conducting pharmaceutical microbial experiments, help to gain a complete understanding of pharmaceutical microbiology. As a result, according to²⁴, this will ensure sufficient emphasis on highlighting procedures related to the isolation of antagonistic microorganisms and will increase students' interest in studying, and operational skills, as well as improve the quality of education and teaching in the field of pharmaceutical microbiology.

In the study²⁵, to develop entrepreneurial thinking and skills among pharmacy students, project activities were implemented to create business proposals integrated into the pharmacy management course. The study²⁶ is aimed at providing future pharmacists with the opportunity to act experimentally and interdisciplinary, using project-based training.

According to²⁷, the addition of a project-based method to the curriculum of the pharmacotherapy course under the Doctor of Pharmacy program (PharmD) to assess events related to infectious diseases is considered an effective teaching method. According to the results of a survey of the students themselves²⁶, this training increased students' awareness of current events related to pharmacy practice.

The paper²⁸ presents a proposal for the design of project training in various subjectsincluded in the programof the 2nd, 3rd, and 4th yearsof pharmacy studies (organic chemistry, pharmaceutical chemistry,pharmacokinetics, and pharmaceutical technology). The introduction ofthis methodologyallowed the authors to check the effectiveness of the developmentof certain skills and their preservationover time since they were evaluated indifferent subjectsof successive courses.

In²⁹, the inclusion of the project-based method in existing English for special purposes (ESP) programs is proposed as a solution to problems related to the practice of teaching and learning ESP. The findings of the study show that adding the project-based method to ESP classes gives students significant advantages.

However, they do not fully answer the question due to their limited conceptual orientation, the diverse nature of the main phases of the lifecycle, and their discrete reflection and limited integration with professional competencies in training personnel for research activities. Therefore, it is of scientific and practical interest to study the possibilities of using well-known models of project lifecycle management for students' research activities.

The purpose of the paper is to determine the possibilities of using project lifecycle management models based on the PMI PBMOK-6 methodology in the RP of students receiving higher pharmaceutical education.

MATERIALS AND METHODS:

The following project lifecycle management models were investigated: rigid (cascade model, or waterfall model, iterative model, V-model) and flexible models (Agile models, AZ model).

The models were evaluated by 19 experts in the fields of knowledge of the Six-Pointed Star (SPS) PMBOK model, specially designed for these purposes (Figure 1, Table 1)³⁰. The model includes two triangles. The areas of knowledge of the first triangle (schedule (time), scope, and cost) are considered input/output factors of the project, and the areas of knowledge of the second triangle (risk, resource, quality) are considered factors of subject processes. The experts expressed their opinion by e-mail using the expert assessment card. The card included questions on each of the areas of knowledge of the SPS PMBOK model separately for rigid and flexible lifecycle models in small-, medium- and large-scale (SS, MS, and LS) RP groups (Table 2)³¹. The experts evaluated the questions according to the Likert scale (strongly disagree, rather disagree, neutral, rather agree, completely agree). The ratings "completely agree" and "rather agree" on the Likert scale were considered positive ratings. If the expert had experience working with more than one rigid or flexible model, then they provided two expert cards.

Figure 1. The SPS PMBOK model used to analyze project lifecycle management models³⁰

Table 1: Distribution of the experts who analyzed the studied lifecycle management models in project management

Lifecycle management model	Number of experts (%)
Cascade model	18 (94.7)
Iterative model	8 (42.1)
V-model	6 (31.6)
Agile models	15 (78.9)
AZ model	6 (31.6)

Table 2: Categorization of works into SS, MS, and LS

Indicator	SS projects	MS projects	LS projects
Duration	Less than 6 months	From 6 to 12 months	12 months or more
Number of performers	Up to 5 people	From 5 to 20 people	20 people or more
Integration	Minimal with other divisions	Moderate with other divisions	Significant with other divisions

To confirm the possibilities of practical use of project lifecycle models in the research activities of students majoring in Pharmacy, experts were asked to choose the optimal project approach to managing the lifecycle of a specific student's RP in the fields of knowledge of the SPS PMBOK model. For example, we took an MS RP carried out at the Department of Pharmacy of the Sechenov First Moscow State Medical University by a team of 4th-year students under the guidance of teachers in the Pharmaceutical Marketing field on the topic "Marketing evaluation of consumer preferences in using mobile apps for healthcare to support drug adherence"³².

Characteristics of experts. Of the 19 experts in the field of project management and research activities participating in the study, 13 people were specialists in the field of pharmacy (68.4%), and 6 were specialists in other fields (31.6%). All experts (100%) had experience as research advisors and 94.7% managed their students' research using the methodology and methods of project management. Distribution of the experts by positions: head of the center, deputy director for scientific work, head of the department: 1 person each (5.3%), professors: 2 (10.5%), associate professors: 7 (36.8%), senior researchers: 3 (15.7%), senior lecturers: 2 (10.5%), junior researchers and assistants: 1 person each (5.3% each). Distribution of the experts by experience with lifecycle management models: up to 3 years: 1 person (5.3%), from 3 to 5 years: 11 (57.9%), from 5 to 10 years: 5 (26.3%), 10 years or more: 2 (10.5%). All experts (100%) work in government-funded, very large organizations and have experience in using rigid and flexible models.

Statistical data processing was carried out using the IBM SPSS Statistics 28.0.1 software. The reliability of the differences between the experts' estimates of the models was carried out according to Student's t-criterion. The critical level of significance when testing statistical hypotheses in the study was assumed to be 0.05.

RESULTS:

Rigid models vs. rigid models:

a) Cascade model vs. iterative model:

The results of a comparative analysis of the waterfall model with an iterative model in the first triangle of knowledge areas (schedule, scope, and cost) in the SPS PMBOK model are presented in Figure 2A. From the point of view of the schedule, the cascade model is more suitable for SS and MS students' RP, and the iterative model is best applied for lLS projects. According to the results of the analysis of the scope of the RP, the iterative model is more reliable than the waterfall model in LS projects. For MS projects, both models had the same results. From the cost point of view, an RP is carried out within the established budget more often when using an iterative model than a cascade model, in medium and large-scale works.

Within the framework of the second triangle of knowledge areas (risk, resource, quality) in the SPS PMBOK model, the iterative model managed risks well in large students' RP (Figure 2B). The iterative model made maximum use of resources in LS projects. The most important area of knowledge is quality. The iterative model provides a better product in MS and LS RP than the cascade model.

Figure 2. Results of comparative analysis of cascade and iterative models within the framework of the first (A) and second (B) triangles of the SPS PMBOK model concerning the management of students' RP (in Figures 2-5: F_av is the average frequency of occurrence of positive evaluations; SS is a small-scale RP; MS is a medium-scale RP; LS is a large-scale RP)

b) Cascade model vs. V-model:

Figure 3A presents the results of a comparative analysis of the cascade model with the V-model in the first triangle of knowledge areas within the framework of the SPS PMBOK model concerning the management of students' RP. When developing a schedule for MS and LS RP, the waterfall model is preferable to the V-model. In terms of scope, the cascade model is more reliable for MS projects than the V-model. The performance of RP within the established budget is higher in the waterfall model for all types of work compared to the V-model.

In the second triangle of the SPS PMBOK model (Figure 3B) in the V-model, the risk can be easily minimized in the RP of students of any scale. The resources in the V-shaped model are used to the maximum in all work sizes compared to the cascade model. The product developed based on the V-model is of higher quality than when using the waterfall model in small, medium, and large RP.

Figure 3. Results of a comparative analysis of the cascade model and the V-model within the first (A) and second (B) triangles of the SPS PMBOK model concerning the management of students' research

c) Iterative model vs. V-model:

The results of comparing the iterative model with the V-model in the first triangle of knowledge areas in the SPS PMBOK model concerning the management of students' RP are shown in Figure 4A. The schedule field of knowledge is presented in the best possible way in LS RP made by students in an iterative model compared to the V-model. According to the results of the analysis of the scope of RP, the iterative model is more rational in the application for MS and LS projects than the V-model. The iterative model performs all tasks within the established budget compared to the V-model in all types of students' RP.

When we studied the areas of knowledge within the second triangle of the SPS PMBOK model (Figure 4B), there were no significant differences between the iterative model and the V-model in terms of risks, resources, and quality.

Figure 4. Results of comparative analysis of the iterative model and V-models within the first (A) and second (B) triangles of the SPS PMBOK model applied to the management of students' RP

Flexible models vs. flexible models:

a) Agile models vs. the AZ model:

The results of a comparative analysis of Agile models with the AZ model when using the first triangle of the SPS PMBOK model concerning the management of students' RP are shown in Figure 5A. The Agile models were preferable in terms of schedule and cost in SS, MS, and LS projects.

Within the framework of the second triangle of knowledge areas of the SPS PMBOK model (Figure 5B), the risks in the AZ model were handled better than in Agile models, in RP of any size. The AZ model uses maximum resources in LS projects. SS and MS RP involve approximately the same resources of flexible models. Using flexible models always allows for making good quality products, but, according to the results of the study, the AZ model is preferable to Agile models in terms of quality in works of any level.

Figure 5. Results of a comparative analysis of Agile models and the AZ model within the first (A) and second (B) triangles of the SPS PMBOK model concerning the management of students' RP

Rigid and flexible models applied to a specific student's RP:

For the experts' implementation of a comparative analysis of rigid and flexible models for the management of the lifecycle of a specific student's RP in the field of Pharmacy, the most common models (cascade model, iterative model, and Agile models) were taken for the SPS PMBOK knowledge areas. The distribution of experts analyzing the studied lifecycle management models corresponded to the data in Table 1. It was found that within the framework of the first triangle of SPS PMBOK knowledge areas, the Agile models were preferable for use in students' RP in question compared with the cascade model in the schedule and cost fields of knowledge (Figure 6). The flexible models also had advantages over the iterative model in terms of RP execution time. In the second triangle of the SPS PMBOK model, the Agile models were better for managing risks and resources in the analyzed students' RP compared to the cascade model. In the quality field of knowledge, the Agile model and the iterative model were preferred over the waterfall model.

Figure 6: Results of the study of rigid and flexible models applied to a specific students' RP in the Pharmacy field by SPS PMBOK fields of knowledge: F_av is the average frequency of occurrence of positive ratings

The generalized data of comparative analysis of models reflecting the main approaches to the management of the lifecycle of students' RP in the SPS PMBOK fields of knowledge showed that rigid models were not significantly inferior to flexible models (F_av=73.9±2.8% for rigid models; F_av=78.7±2.4% for flexible models). This applied to both SS and MS RP (F_av=74.1±2.9% and 79.6±2.4% for rigid and flexible SS models, respectively; F_av=73.7±2.7% and 78.7±2.4% - for rigid and flexible MS models, respectively), and LS projects (F_av=74.0±2.7% and 77.7±2.5% – for rigid and flexible LS models, respectively).

Among rigid models, the V-model has proven itself well compared to the cascade model in all areas of knowledge of the second triangle of the SPS PMBOK model (F_av=77.4±2.3% for the V-model; F_av=68.0±2.4% for the cascade model). In this model, each phase of the RP lifecycle is completed before the start of the next phase. The model provides support in the planning and implementation of the RP. When using it, the RP becomes more transparent and the quality of control improves by standardizing intermediate goals and describing the results corresponding to them. This makes it possible to identify deviations in RP at the early stages (sub-components) of the lifecycle and improves the quality of RP management. Since the V-model is quite simple and suitable for SS and MS RP, it is rational to use it when managing the RP of junior students. The iterative model was better than the cascade model for LS RP in both the first and second triangles of the SPS PMBOK model (F_av=82.7±2.8% and 74.1±2.6% for the iterative and cascade models of the first triangle, respectively; F_av=76.4±2.4% and 66.6±2.2% for the iterative and cascade models of the second triangle, respectively). In the iterative model, the phases of the RP lifecycle are inconsistent, it is allowed to start work on the next phase before the completion of the previous one. It is possible to go through all phases of the RP lifecycle in several iterations, while a new prototype is created for each iteration and the relevance of the requirements for which it was created is checked. The strengths of the iterative model include high work efficiency when performing long-term RP and those works where requirements change over time. In our opinion, the iterative model should be used in the management of RP of senior students. The cascade model provides for a sequential transition from one phase of the RP lifecycle to another while skipping any phase or returning to the previous one is impossible. The cascade model is very simple, clear, and easy to use, each phase of it is clearly defined. The model works effectively for RP where the requirements are defined and the probability of their change is small. This model can be recommended for use in various types of RP and students of both the first two and last two years.

The Agile flexible models are based on the values and principles of Agile methodology^33-35. They showed better results compared to the AZ model in the schedule and cost fields of knowledge of the first triangle of the SPS PMBOK model (F_av=80.2±2.2% and 72.9±2.2% for the Agile models and the AZ model by schedule, respectively; F_av=81.7±2.2% and 73.7±2.3% for the Agile models and the AZ model by cost, respectively). When using Agile models, there is no need for proper planning, but there is a clear set of future work. They are easy to manage the RP lifecycle and the product delivery speed is high. Flexible Agile models are suitable for managing various types of RP in students of all years. The AZ model is one of the latest models that combines the positive aspects of flexible and rigid models but mainly fits the category of flexible models. It surpassed Agile models in the quality and risk fields of knowledge of the second triangle of the SPS PMBOK model (F_av=86.2±2.4% and 79.0±2.2% for the AZ model and Agile models by quality, respectively; F_av=84.6±2.3% and 77.1±2.2% for the AZ model and the Agile models by risk, respectively). This is because the main focus in the AZ model is on improving the quality of the product. The AZ model is advisable to use for both SS and LS RP in senior students.

Generalized data on the selection by experts of the optimal project approach to the lifecycle of a specific MS student's RP in the Pharmacy field, SPS PMBOK showed that flexible Agile models were preferable to the rigid cascade model and were not inferior to the rigid iterative model (F_av=78.9±2.4% for the Agile models; F_av=71.2±2.6% for the cascade model; F_av=75.4±2.6% for the iterative model). The Agile models outperformed the waterfall model in all fields of knowledge of the first and second triangles of the SPS PMBOK model, except for the scope indicator. The Agile models were also better than the iterative model in the schedule field of knowledge. According to the experts, the use of flexible Agile models and the iterative model allows us to obtain better results when performing the analyzed RP compared to the cascade model. This is due to the possibility of dividing the process of interviewing intermediate and final consumers (real and potential) into repetitive cycles, allowing for using the gradually stratified method to cover all target segments of consumers, fully consider emerging new requirements and changes in the pharmaceutical market, reduce the impact of risks in the early stages of RP, which leads to minimizing the costs of their elimination, and reduce the time to perform RP when using Agile methods.

DISCUSSION:

As a result of a comparative analysis of the project lifecycle management models, their preferential opportunities for application in the RP of students in higher pharmaceutical education in each of the fields of knowledge of the SPS PMBOK model have been established.

It has been shown that rigid and flexible models of project lifecycle management can be selectively used in the RP of junior and senior students, depending on the priority of individual areas of knowledge of project management and the scale of the RP.

It has been established that rigid models are not inferior to flexible models in both SS, MS, and LS RP. It has been shown that among rigid models, the iterative model and the V-model were better than the cascade model in some fields of knowledge of SPS PMBOK and at a certain scale of RP. Among flexible models, the Agile models were superior to the AZ model in the schedule and cost fields of knowledge, and the AZ model was better than the Agile models in terms of quality and risk.

The data obtained were confirmed by the example of a specific student's RP in the Pharmacy field when choosing the optimal project-based approach to lifecycle management in the fields of knowledge of the SPS PMBOK model. For a more detailed study of the process of choosing a project lifecycle management model for students' RP, it is necessary to create an algorithm for this process.

As examples, we can cite project activities in the field of pharmaceutical education in the project "Testing the restriction of oral medication Shuanghuanglian by microorganisms", aimed at teaching students skills in conducting pharmaceutical microbial experiments²⁴; project activities to simulate the process of submitting commercial proposals and obtaining approval in the real world, including operational procedures, location and layout design, inventory management, personnel management, marketing management, and financial management²⁵.

The paper²⁶describes a student experiment in which pharmaceutical students were asked to develop a solid dosage form (chocolate pills). In²⁷, the addition of a presentation of events related to infectious diseases as a project task significantly increased students' awareness of the course of the pandemic related to pharmacy practice and their understanding of the process of preparing and presenting the information.

CONCLUSION:

In the course of our study, the possibilities of using project lifecycle management models based on the PMI PBMOK-6 methodology in students' RP in higher pharmaceutical education have been identified.

As a result of the study, it has been found that rigid and flexible models can be selectively applied in the RP of junior and senior students, depending on the priority of individual areas of knowledge of the SPS PMBOK model and the scale of work; the possibilities of using project lifecycle management models in students' RP in each of the areas of knowledge of the SPS PMBOK model are shown.

The study limitations include the size of the expert sample. The prospect of further research may be the creation of an algorithm for the process of choosing a project lifecycle management model for students' RP.

CONFLICT OF INTEREST:

There is no conflict of interest to declare.

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Received on 05.05.2023 Modified on 09.06.2023

Research J. Pharm. and Tech 2023; 16(12):5782-5789.

DOI: 10.52711/0974-360X.2023.00936