Abstract
For the intense and rapid development of innovative drugs, the active participation of
physicians familiar with diseases and treatments in clinical practice is highly important.
To facilitate the involvement of physicians in drug development, we have started a
practicum of drug development, especially for medical students, as part of a program by
the Ministry of Education, Culture, Sports, Science and Technology (MEXT) to establish
human resource training centers for future medical research. The practicum comprised
lectures by experts involved in clinical development and regulatory science and adopted an
active learning style centered on group work. Free descriptive reviews, which were
provided by the trainees after completion of the practicum, revealed changes in their
perception of pharmaceutical companies from stereotypical profit-pursuing entities to
entities with an important role in drug development. Semi-structured analysis also
indicated that this practicum allowed participants to recognize the importance of
education that fosters collaboration among all healthcare professionals in drug
development. Continued implementation of the present practicum is important to promote the
involvement of physicians and the securement of experts in drug development, which will
ultimately enable the intense and rapid development of innovative drugs.
Highlights
• An educational program on drug development was offered to medical students and physicians
from multiple universities and hospitals
• One of the key components for the success of the program was the participation of
pharmaceutical companies that voluntarily or gratuitously accepted trainees
• Based on the questionnaire, the perception of trainees regarding drug development changed
after the practicum. In fact, the program helped healthcare professionals recognize the
importance of educating individuals on drug development
Introduction
As drug development has become more diverse and complex, training experts in each drug
development stage (i.e., from pre-clinical to clinical), including the post-marketing stage,
has become increasingly necessary. In particular, to enable the rapid development of
innovative drugs, it is critical for physicians, who are familiar with diseases and
treatments in clinical practice, to learn and participate in drug development, as they play
a leading role in this field.
However, the close interaction of medical students or physicians with pharmaceutical
companies may lead to an increase in the number of prescriptions for products made by those
pharmaceutical companies and a decrease in the quality of prescription [1, 2]. From a
regulatory perspective, efforts to achieve transparency between physicians’ research
institutions and pharmaceutical companies have been promoted since the enactment of the
Clinical Research Act triggered by a scandal on improper clinical research [3]. Thus, physicians and pharmaceutical companies are
currently focusing on maintaining an “appropriate” distance. Furthermore, only a small
emphasis is being placed on the close collaboration between physicians and pharmaceutical
companies for the early development of innovative drugs. From the viewpoint of medical
institutions, physicians in Japan have fewer opportunities for training related to clinical
trials and spend less time on clinical trials than physicians in other countries [4]. The lack of practical training experience in medical
students and physicians, such as direct physician involvement in clinical trials, may lead
to a low interest in participating in drug development and a biased perception of this
activity. Consequently, physicians may not be motivated to apply their medical expertise to
aid in the process of drug development.
Organizations promoting pharmaceutical medicine, including some academic societies such as
the Japanese Association of Pharmaceutical Medicine (JAPhMed), have established accredited
programs for postgraduate education in pharmaceutical medicine [5]. However, many physicians in these societies work for the
pharmaceutical companies. Thus, their interest and understanding of pharmaceuticals are
high.
In recent years, Japanese organizations promoting the involvement of physicians in drug
development, such as the Institute of Drug Development Career Promotion (DDCP), have sought
to actively encourage physicians to contribute to drug development [6]. However, the number of physicians who intend to engage in drug
development remains low. In other countries, training medical students in drug development
has been reported to advance their knowledge of the subject [7]. However, in Japan, the opportunity to receive education on drug development is
limited to physicians.
To address these problems, drug development learning opportunities should not only be
provided to physicians interested in the field, but also to physicians working at hospitals
or medical students who will choose this as their career path in the future. We hypothesized
that such practical education on drug development may motivate them to seek a comprehensive
understanding of the various roles of physicians (i.e., from drug development to
post-marketing activities) and eventually participate in the process of drug development.
Therefore, incorporating the professional viewpoints of physicians in drug life-cycle
management may lead to the rapid development of innovative drugs.
To test our hypothesis regarding the effectiveness of practical education for gaining a
better understanding of drug development, particularly among medical students, we started a
practicum on drug development for medical students (hereinafter referred to as the
“practicum”) at Tokyo Medical and Dental University as part of a program by the Ministry of
Education, Culture, Sports, Science and Technology (MEXT) to establish human resource
training centers for future medical research. AbbVie GK, a pharmaceutical company, was
involved in the activities and acceptance of trainees, which included medical students and
physicians from multiple universities and university hospitals, respectively. Although this
project was completed in FY 2017, the practicum is continuously being implemented as a part
of selective clinical training for medical students in their sixth year. Furthermore, AbbVie
GK continues to accept medical students and physicians from multiple universities as
trainees.
In our study, we introduced an outline of the practicum. To evaluate trainees’
understanding, interest, and perception of drug development owing to the practicum,
questionnaires were administered to assess their learning achievements. The trainees were
also asked to submit a descriptive review that was analyzed after the practicum. The
importance of this type of program was discussed according to the changes in participants’
perceptions of drug development after the practicum.
Material and Methods
The objectives of the practicum were as follows:
i) To outline the steps involved in clinical development and regulatory science in
pharmaceutical medicine and
ii) To simulate the actual working environment of a pharmaceutical company to promote
familiarity among participants.
To achieve objective (i), a lecture was given by experts in clinical development and
regulatory science to provide basic knowledge of these areas. For objective (ii), an active
learning style centered on group work was employed to provide practical knowledge and deep
understanding via a simulated experience of actual operations at a pharmaceutical company
based on the knowledge obtained in objective (i). To complement this learning, trainees were
allowed to interact with clinically experienced AbbVie physicians to advance their
understanding of the contributions of companies to clinical and pharmaceutical medicine.
Another goal was to cultivate issue-solving abilities through discussions with other
participants and pharmaceutical companies that accepted the participants as trainees. In the
active learning sessions for objective (ii), group work was performed three to four times
per practicum.
AbbVie, the hosting pharmaceutical company, formed a task force to review the structure of
the practicum to demonstrate the true state of pharmaceutical companies at the forefront of
drug development while achieving the above objectives. The following individuals were
invited to serve as members of the task force: individuals with abundant clinical
development experience, individuals who participated in an internship program at a company,
and individuals with medical licenses and clinical and work experiences at any
pharmaceutical company. These members discussed the structure of the practicum. To evaluate
the learning effect of the practicum, questionnaires were designed and administered to
participants to assess their degree of understanding and interest in drug development. The
questionnaires were finalized through consultation with a doctor who was an expert in
medical education and had a business contract with AbbVie.
An example of the practicum is presented in Table
1. Each practicum was held as a 2-day program, and the structure of each was
slightly changed based on the requests of the participants after the end of each program.
However, the contents of the practicum were organized to achieve objectives (i) and
(ii).
Table 1.
Examples of the practicum
|
Day 1 |
Day 2 |
| AM |
Overview of drug development (pharmaceutical industry/non-clinical/
clinical/regulatory) |
Overview of pharmacovigilance/post-marketing surveillance Joining the
DSC Workshop (review case card) |
| PM |
Workshop (site selection, IRB) |
Discussion with physicians that are part of a pharmaceutical company
Reflection |
IRB: Institutional Review Board; DSC: Drug Safety Committee.
In addition to the task force members, other experts in the field conducted lectures or
provided support as needed.
This practicum was originally administered to sixth-year medical students at Tokyo Medical
and Dental University. Yamagata University and Kanazawa University have been participating
in this practicum since 2018, and medical students or young doctors from these universities
have been recruited as trainees.
Questionnaire summary
This practicum has been held once or twice a year since 2017, and the questionnaire was
completed four times up to 2019.
In all instances, questionnaires were administered after each session ended. The
questionnaire consisted of a self-administered numerical rating for comprehension
(learning achievements) and a free descriptive review. The questionnaires were designed in
collaboration with physicians, who were experts in medical education and had business
contracts with AbbVie.
Questionnaire for assessing learning achievements
In the self-evaluation of learning achievements, the level of understanding was
confirmed using a 5-point numerical evaluation. The questions were designed to evaluate
whether participants could explain the lessons learned from each session.
As sessions were added or deleted, and after each session, questions were reviewed as
appropriate, the questions differed depending on the sessions. The scores were averaged
per session and participant, and the mean, maximum, and minimum averages were derived
for each session.
Questionnaire for the free descriptive review
After completing the practicum, participants were asked to review the practicum through
a free descriptive review form. Questions A–E were designed to aid the review, and a
sheet was distributed for each question (five sheets in total):
A) What were the participants’ perceptions of drug development and pharmaceutical
companies before the start of the practicum? (hereinafter referred to as “before the
practicum”)
B) Did the participants’ perceptions change after the practicum? If so, how?
(hereinafter referred to as “after the practicum”)
C) What did the trainees learn through the practicum in terms of problems with drug
development or ideas for improvement if possible? (hereinafter referred to as “problems
and improvements”)
D) What conditions and environmental improvements are necessary to overcome ethical
problems related to drug development and problems related to interactions between
physicians and pharmaceutical companies (including the establishment of laws)?
(hereinafter referred to as “conditions and environmental improvements”)
E) How was the program itself? (hereinafter referred to as “request for the
practicum”)
All the responses obtained from participants until 2019 (four programs in total) were
subjected to semi-structured analysis. Keywords reflecting the topics described by
participants were divided into the following three categories (Groups 1–3):
1. Group 1 (keyword 01–08): Keywords reflecting companies as profit-oriented
entities:
Pharmaceutical company/company, non-physician, sales, drug prices, marketing, profit,
cost, and medical representatives (MR).
2. Group 2 (keyword 09–20): Keywords reflecting companies as development partners:
Pharmaceutical process, development, medicine, clinical study/clinical trial, efficacy,
time, new drug, post-marketing surveillance, safety, pharmaceutical products, drug
discovery, and physicians in pharmaceutical companies.
3. Group 3 (Keyword 21–30): Keywords reflecting corporate social responsibilities:
Responsibility, law and regulations, ethics, speed, education, information provision,
patients, notification, reporting, and clinicians.
After establishing these categories and keywords, a response analysis of the frequency
(expressed as a percentage) of each keyword in the overall responses was performed. To
avoid bias in the decision to set up keywords and link each keyword, two independent
evaluators chose the keywords autonomously, agreed in advance, attached a marker to
parts that seemed to refer to each keyword, and calculated the ratio of each keyword to
the entire sentence. In the free descriptive review, as the number of responses differed
for each question, the ratio was calculated as a percentage, which was then converted
into a frequency score (range: 0–100). The number of words/sentences that appeared to
refer to each keyword in the entire response was counted as the number of references.
The frequency score and number of references were calculated using the free-text
analysis program NVivo ver. 11 (QSR International, Burlington, MA, USA). The frequency
score and number of references were calculated as the mean of the data from two
independent evaluators.
Results
Practicum overview
This practicum was held twice in 2017, once in 2018, and once in 2019. Table 2 provides information on the participants
up to 2019 (four programs in total).
Table 2.
Breakdown of the participants
| Training year |
Occupation/number of participants from each
university |
| Tokyo Medical and Dental University |
Yamagata University |
Kanazawa University |
| 2017_1st |
6th-year student/3 participants |
|
|
| 2017_2nd |
6th-year student/3 participants |
|
|
| 2018 |
6th-year student/6 participants |
6th-year student/2 participants |
|
| 2019 |
6th-year student/2 participants |
Physician/2 participants |
Physician/2 participants |
The by-session mean, minimum, and maximum scores for the main program sessions are listed
in Table 3. In general, a certain level of
understanding was suggested to be achieved after each session, despite variations among
sessions. Inter-program variability tended to be larger than inter-session variability in
the same practicum, which may be due to the number of participants, characteristics of
individual participants, and level of understanding before the practicum.
Table 3.
By-session mean, minimum, and maximum scores of the main program sessions
| Training year (Number of trainee) |
Main sessions |
Score (Mean) |
Score (minimum, maximum) |
| 2017_1st (n=3) |
Clinical trial |
4.38 |
4.00, 5.00 |
| Overview of PV/PMOS |
4.39 |
4.06, 4.71 |
| Let’s plan a clinical trial |
4.71 |
4.57, 4.86 |
| 2017_2nd (n=3) |
Clinical trial |
4.93 |
4.80, 5.00 |
| Overview of PV/PMOS |
5.00 |
5.00, 5.00 |
| Let’s plan a clinical trial |
5.00 |
5.00, 5.00 |
| 2018 (n=8) |
Preclinical and clinical trial |
4.21 |
3.85, 4.69 |
| Overview of PV/PMOS |
4.23 |
3.65, 4.65 |
| Let’s plan a clinical trial |
4.25 |
3.54, 5.00 |
| Regulatory affairs |
3.98 |
3.57, 4.33 |
| Cost and speed |
4.09 |
4.00, 4.75 |
| Relationship between physicians and MSL |
4.23 |
3.57, 5.00 |
| 2019 (n=6) |
Preclinical and clinical trial |
4.17 |
3.70, 5.00 |
| Overview of PV/PMOS |
4.25 |
3.82, 5.00 |
| Let’s plan a clinical trial |
4.11 |
3.83, 4.58 |
| Regulatory affairs |
4.07 |
3.57, 5.00 |
| Cost and speed in clinical trial |
4.30 |
4.00, 4.60 |
| Role-play of site selection |
4.33 |
4.00, 4.50 |
*5-point scale (5: very likely, 1: not at all).
PV: Pharmacovigilance; PMOS: Post Marketing Surveillance; MSL: Medical Science
Liaison.
Based on the semi-structured analysis of all the responses from participants until 2019
(four programs in total), the ratio of each keyword (Groups 1–3) relative to the whole
sentence (frequency score) and the number of words/sentences referred (number of
references) in parts where each keyword was mentioned were calculated. The results are
presented in Table 4Table 5Table 6.
Table 4.
Frequency score and number of references in Group 1 (companies as profit-oriented
entities)
|
Number of referred sheets* |
Frequency score |
Number of references |
Total number of references |
| Before the practicum |
After the practicum |
Problems and improvements |
Conditions and environmental improvements |
Request for the practicum |
Before the practicum |
After the practicum |
Problems and improvements |
Conditions and environmental improvements |
Request for the practicum |
| Pharmaceutical company /Company |
5 |
53.26 |
51.26 |
3.31 |
30.2 |
3.13 |
21 |
27 |
3 |
13 |
5 |
69 |
| Non-physician |
5 |
4.46 |
2.6 |
0.75 |
3.48 |
0.8 |
8 |
6 |
2 |
7 |
1 |
24 |
| Sales |
4 |
4.29 |
2.84 |
0.56 |
3.32 |
0 |
6 |
7 |
1 |
3 |
0 |
17 |
| Drug price |
4 |
0.77 |
0.64 |
5.37 |
0 |
0.47 |
1 |
2 |
3 |
0 |
1 |
7 |
| Marketing |
4 |
10.03 |
0 |
0.19 |
2.12 |
0.47 |
6 |
0 |
1 |
3 |
1 |
11 |
| Profit |
3 |
10.03 |
3.04 |
0 |
1.85 |
0 |
5 |
3 |
0 |
2 |
0 |
10 |
| Cost |
4 |
9.52 |
1.47 |
13.43 |
1.47 |
0 |
8 |
3 |
5 |
2 |
0 |
18 |
| MR |
3 |
9.01 |
0 |
0.12 |
1.41 |
0 |
5 |
0 |
1 |
2 |
0 |
8 |
*Questions A to E were provided on separate sheets (five sheets in total). MR:
Medical Representative.
Table 5.
Frequency score and number of references in Group 2 (companies as development
partners)
|
Number of referred sheets* |
Frequency score |
Number of references |
Total number of references |
| Before the practicum |
After the practicum |
Problems and improvements |
Conditions and environmental improvements |
Request for the practicum |
Before the practicum |
After the practicum |
Problems and improvements |
Conditions and environmental improvements |
Request for the practicum |
| Pharmaceutical process |
5 |
19.9 |
20.93 |
12.37 |
2.83 |
0.47 |
10 |
18 |
9 |
3 |
1 |
41 |
| Development |
5 |
27.87 |
21.81 |
24.11 |
2.12 |
1.93 |
9 |
13 |
12 |
1 |
1 |
36 |
| Medicine |
5 |
23.93 |
28.97 |
49.22 |
10.88 |
1.4 |
12 |
20 |
18 |
5 |
1 |
56 |
| Clinical study /clinical trial |
5 |
1.97 |
12.21 |
30.29 |
12.62 |
1.4 |
2 |
7 |
7 |
4 |
2 |
22 |
| Efficacy |
1 |
0 |
2.35 |
0 |
0 |
0 |
0 |
2 |
0 |
0 |
0 |
2 |
| Time |
4 |
0.77 |
3.33 |
17.68 |
0.27 |
0 |
1 |
4 |
11 |
1 |
0 |
17 |
| New drug |
4 |
25.47 |
25.74 |
46.41 |
3.75 |
0 |
11 |
20 |
17 |
3 |
0 |
51 |
| PMOS |
2 |
0 |
5.64 |
0 |
1.63 |
0 |
0 |
8 |
0 |
1 |
0 |
9 |
| Safety |
4 |
2.83 |
5.49 |
4.87 |
1.47 |
0 |
1 |
6 |
2 |
2 |
0 |
11 |
| Pharmaceutical products |
5 |
26.33 |
28.97 |
49.22 |
10.77 |
1.4 |
13 |
20 |
18 |
5 |
1 |
57 |
| Drug discovery |
5 |
27.7 |
26.37 |
41.72 |
3.05 |
1.13 |
12 |
21 |
16 |
2 |
1 |
52 |
| Physicians in pharmaceutical companies |
3 |
8.23 |
5.88 |
0 |
0 |
4.46 |
4 |
4 |
0 |
0 |
2 |
10 |
*Questions A to E were provided on separate sheets (five sheets in total). PMOS: Post
Marketing Surveillance.
Table 6.
Frequency score and number of references in Group 3 (corporate social
responsibilities)
|
Number of referred sheets* |
Frequency score |
Number of references |
Total number of references |
| Before the practicum |
After the practicum |
Problems and improvements |
Conditions and environmental improvements |
Request for the practicum |
Before the practicum |
After the practicum |
Problems and improvements |
Conditions and environmental improvements |
Request for the practicum |
| Responsibility |
2 |
0 |
5.59 |
0 |
1.09 |
0 |
0 |
3 |
0 |
1 |
0 |
4 |
| Laws and regulations |
3 |
0 |
0.39 |
0.44 |
7.73 |
0 |
0 |
1 |
1 |
4 |
0 |
6 |
| Ethics |
2 |
0 |
2.01 |
0 |
3.05 |
0 |
0 |
4 |
0 |
8 |
0 |
12 |
| Speed |
2 |
0 |
0.93 |
7.31 |
0 |
0 |
0 |
1 |
5 |
0 |
0 |
6 |
| Education |
4 |
25.47 |
25.74 |
46.41 |
3.75 |
0 |
11 |
20 |
17 |
3 |
0 |
15 |
| Information provision |
4 |
1.29 |
1.67 |
10.56 |
11.64 |
0 |
1 |
3 |
3 |
9 |
0 |
16 |
| Patients |
3 |
1.29 |
1.67 |
10.56 |
11.64 |
0 |
1 |
3 |
3 |
9 |
0 |
29 |
| Notification |
2 |
0 |
0 |
0.5 |
2.23 |
0 |
0 |
0 |
2 |
4 |
0 |
6 |
| Reporting |
2 |
0 |
2.3 |
0 |
5.33 |
0 |
0 |
3 |
0 |
3 |
0 |
6 |
| Clinician |
4 |
0 |
4.02 |
16.18 |
21.44 |
3.06 |
0 |
2 |
8 |
14 |
2 |
26 |
*Questions A to E were provided on separate sheets (five sheets in total).
As shown in Table 4, Group 1 consisted of
keywords related to the perception of a pharmaceutical company as a profit-oriented
entity. For all keywords, the frequency scores in the responses to Question B (after the
practicum) tended to decrease compared to those in Question A (before the practicum). In
particular, for the keywords of “Sales”, “Profit”, “Cost”, and “MR”, the frequency score
decreased by more than 50% after the practicum compared to those before the practicum.
After the practicum, participants did not mention keywords related to the perception of a
stereotypical profit-seeking company.
In Group 2 (Table 5), which comprised
keywords reflecting companies as development partners, the frequency scores of many
keywords in the responses to Question B (after the practicum) increased compared to those
in the responses to Question A (before the practicum). In particular, the frequency scores
for the keywords “Clinical study/Clinical trial”, “Time”, and “Safety” increased by more
than 50% after practicum compared to those before practicum. In Group 2, the frequency
scores for each keyword were high in the responses to Question C (Problems and
Improvements), particularly those for the keywords “Medicine”, “New drug”, “Pharmaceutical
products”, and “Drug discovery”. After the practicum, the perception of companies as
development partners tended to increase compared to that before the practicum. The
viewpoints on problems and improvements in drug development had also increased.
Table 6 contains the frequency scores and
number of references for Group 3 keywords related to corporate social responsibilities. No
notable trend was observed in Group 3 as a whole; however, the frequency scores tended to
increase in response to Question B (after the practicum) compared to those in response to
Question A (before the practicum). For the keyword “education”, the frequency score was
high in responses to Question C (problems and improvements).
Discussion
The program for establishing human resource training centers for future medical research
began at Tokyo Medical and Dental University in 2017. Following its completion, the
practicum expanded to other universities. As described below, the results of the
questionnaire responses suggest that prior to the practicum, the participants had a biased
perception of pharmaceutical companies as stereotypical profit-seeking entities, and their
view of pharmaceutical companies as leaders in drug development tended to be low. However,
trainees’ perceptions of drug development embodied by receiving practical education on drug
development through the practicum. The practicum contributed to the recognition of future
issues related to drug development, which were only visualized when perceptions were
embodied, and the importance of education to ensure that all healthcare professionals could
be engaged in drug development with a sense of belonging.
Based on the questionnaire response (free descriptive review) analysis, the frequency of
keywords related to the perception of a stereotypical company, such as MR and profit, tended
to decrease in the responses to Question B (after the practicum) compared to the responses
to Question A (before the practicum) (Table 4).
In contrast, the frequency of keywords reflecting companies as development partners tended
to increase in response to Question B (after the practicum) compared to the responses to
Question A (before the practicum) (Table 5).
These results suggest that before the practicum, the participants viewed pharmaceutical
companies as general profit-pursuing entities; however, after the practicum, their
perceptions changed to entities that played an important role in drug development. Examples
of responses to Questions A and B are provided below, and the actual responses support the
aforementioned trend.
(Examples of actual responses)
• I even thought that profits were the top priority because it was a
company. (Question A)
• I had the impression of companies developing drugs for diseases for which revenue
was expected and profit was pursued. (Question A)
• Through this practicum, we learned many things, and our impressions of
pharmaceutical companies have greatly changed. I was strongly impressed by the attitude of
“patients first” because I thought that financial problems were a major factor for
pharmaceutical companies. (Question B)
• Because they are companies, they have no choice but to pursue profit, but I
learned that they are working with passion to ensure that the drugs they have developed
are safe and effective for patients. (Question B)
The keywords with higher frequencies in the responses to Question B (after the practicum)
than Question A (before the practicum) and the keywords frequently mentioned in the
responses to Question C (problems and improvements) were “Clinical study/Clinical trial”,
“Time”, “Safety”, “Medicine”, “New drug”, and “Drug discovery” (Table 5). Although these words are common among people involved in
drug development, our results suggested that medical students had low interest in these
keywords before the practicum. Nevertheless, our findings revealed that medical students
learned basic content related to drug development through this practicum, which enabled them
to think about problems and ideas in drug development that could be improved. In addition,
the frequent mention of the keyword “education” in the responses to Question C (problems and
improvements) (Table 6) implied that the
participants recognized the importance of education in drug development by learning the
complexity and current situation of drug development through this practicum. At medical
schools in Japan, opportunities for students to systematically learn about drug development
and to directly observe physicians involved in drug development through medical practices
are limited. In contrast, medical students in other countries gain deep knowledge of drug
development through medical school training [7]. The
following responses to Question C indicate that the participants in this practicum felt the
importance of promoting a comprehensive understanding of drug development not only among
people in pharmaceutical companies but also among healthcare professionals.
(Examples of actual responses)
• I felt that the low awareness of not only patients but also physicians and nurses
about clinical trials and development was a problem. If more accurate information is
disseminated, drug development will proceed smoothly. (Question C)
• From a good trial implementation perspective, it might be beneficial to encourage
more physicians to participate in clinical trials (is it something like student
education?). (Question C)
As described above, continuing this practicum and providing medical students with
opportunities to receive education on drug development are expected to promote a
comprehensive understanding of pharmaceutical medicine among physicians, ultimately
increasing their interest in drug development, emphasizing their major role in drug
development, and fostering a sense of belonging.
However, under the current regulations in Japan, restrictions, such as the enactment of the
Clinical Research Act, emphasize the maintenance of an appropriate distance between
pharmaceutical companies and physicians. To investigate the perceptions of the participants
on this issue, Question D was designed to cover conditions and environmental improvements,
including the legislation necessary to overcome ethical problems related to drug development
and problems related to the ideal relationship between physicians and pharmaceutical
companies. Although the responses to Question D did not show an obvious trend, participants
highlighted the importance of healthcare professionals gaining a comprehensive understanding
of drug development in terms of overcoming ethical problems and issues related to the
interaction between physicians and pharmaceutical companies.
(Examples of actual responses)
• Many physicians have only a single background, and the fact that they have
considerable responsibility and management is one of the factors that can cause ethical
problems. In this era of increasingly complex and specialized needs, it is important to
train physicians, medical students, and healthcare professionals to deal with complex
issues. (Question D)
• I think it is difficult because of the patent issue, but if we make interactions
and decision processes among physicians, MRs, pharmaceutical companies, and so on, we can
reduce fatal problems, such as data manipulation and falsification. (Question
D)
To improve the effectiveness of this practicum, education representing a good balance
between development and regulation must be provided. Education programs should outline the
activities that should be actively conducted to enhance drug development, activities that
should be restricted in clinical studies to ensure their quality and reliability, and the
background of various regulations. Advancements in the research and development of drugs
will require the active participation of physicians in drug development. Therefore, it is
extremely important for physicians familiar with disease and treatment in clinical practice
to understand the following points and increase their participation in drug development.
• How pharmaceutical companies plan clinical studies and present the scientific evidence
necessary for approval application in the development stage
• How to present the scientific evidence needed in an actual clinical setting from the
viewpoint of drug selection
• Appropriate timing for submitting approval applications or presenting the scientific
evidence necessary in actual clinical practice, with considerations related to regulations
and operations
• How to appropriately collaborate with pharmaceutical companies to answer research
questions that arise when examining individual patients in clinical practice and clinical
studies
In conclusion, this practicum on drug development for medical students and physicians
changed their perception of drug development and future issues and helped the trainees
recognize the importance of education on drug development to foster a greater participation
of medical professionals in drug development with a sense of belonging. Based on the effects
of this practicum, a comprehensive understanding of the role of the physicians in the
overall life cycle of drugs through these activities may motivate them to participate in
drug development. Opportunities should be provided in the future to allow healthcare
professionals, such as physicians involved in drug development or working in hospitals and
medical students, to choose their career path and learn about drug development. Continued
implementation of this type of practicum and promotion of physician involvement in drug
development are important for the initiation of drug development, rapid development of
innovative drugs, and the development of human resources for these activities.
Conflict of Interest
A draft of the composition of the training program and the contents of lecture/group work
were provided by AbbVie. Trainees were given a lunch box; however, no financial support,
such as transportation or accommodation, was provided. AbbVie collected the participants’
responses to the questionnaire, analyzed the data (learning achievement assessment and free
descriptive review), drafted, reviewed, and approved the manuscript for publication. KT, HN,
MJ, and HY are employees of AbbVie G.K. MU received consultant fees from AbbVie G.K. TT
received lecture fees from MSD K.K., Sumitomo Pharma Co., Ltd., Mitsubishi Tanabe
Pharmaceutical Co., Ltd., Taisho Pharmaceutical Co., Ltd., Novo Nordisk Pharma Ltd., Daiichi
Sankyo Co., Ltd., Kowa company Ltd., Kyowa Kirin Co., Ltd., Cosmic Corporation Co., Ltd.;
and grants from Kowa company Ltd., Taisho Pharmaceutical Co., Ltd., Mitsubishi Tanabe
Pharmaceutical Co., Ltd.; and scholarship donated funds from Astellas Pharma Inc., Novo
Nordisk Pharma Ltd., Taisho Pharmaceutical Co., Ltd., Takeda Pharmaceutical Co., Ltd., Sanwa
Kagaku Kenkyusho Co., Ltd., Ono Pharmaceutical Co., Ltd., LifeScan IP Holdings, LLC., Abbott
Japan LLC., Nippon Boehringer Ingelheim Co., Ltd., Sumitomo Pharma Co., Ltd. KI received
grants from SymBio Pharmaceuticals Ltd., Sanofi K.K., Novartis Pharma K.K., AbbVie G.K.,
Bayer Yakuhin Ltd., IQVIA Services Japan K.K., and Otsuka Pharmaceutical Co., Ltd.; and
personal fees from Novartis Pharma K.K., Takeda Pharmaceutical Co., Ltd., Bristol-Myers
Squibb K.K., Ono Pharmaceutical Co., Ltd., Chugai Pharmaceutical Co., Ltd., Eisai Co., Ltd.,
SRD Co., Ltd., MSD K.K., Micron K.K., Janssen Pharmaceutical K.K., and Kyowa Kirin Co., Ltd.
MN received grants from Takeda Pharmaceutical Co., Ltd., Pfizer Japan Inc., AbbVie G.K., Eli
Lilly Japan K.K., Mitsubishi Tanabe Pharmaceutical Co., Ltd., EA Pharma Co., Ltd., Mochida
Pharmaceutical Co., Ltd., and Janssen Pharmaceutical K.K.; and lecture fees from Takeda
Pharmaceutical Co., Ltd., Pfizer Japan Inc., AbbVie G.K., Gilead Sciences K.K., Eisai Co.,
Ltd., EA Pharma Co., Ltd., Kyorin Pharmaceutical Co., Ltd., Mitsubishi Tanabe Pharmaceutical
Co., Ltd., Kissei Pharmaceutical Co., Ltd., Astellas Pharma Inc., Mochida Pharmaceutical
Co., Ltd., Janssen Pharmaceutical K.K., Zeria Pharmaceutical Co., Ltd., Daiichi Sankyo Co.,
Ltd., and Mylan EPD G.K.
Acknowledgement
The authors thank the AbbVie employees, who participated as lecturers, facilitators, and
task force members for their contributions to the training program.
References
- 1. Miyata,
Y.
2013. Nationwide survey of medical students’ contact behaviors
with pharmaceutical companies.
Igaku-kyoiku
44: 13–19.
- 2. Brax,
H.,
Fadlallah,
R., Al-Khaled,
L., Kahale,
L. A., Nas,
H.,
El-Jardali,
F. and Akl,
E. A.
2017. Association between physicians’ interaction with
pharmaceutical companies and their clinical practices: a systematic review and
meta-analysis. PLoS One
12: e0175493.
- 3. About Clinical Research Act. Document distributed in
clinical research subcommittee held on August 2, 2017. https://www.mhlw.go.jp/file/05-Shingikai-10601000-Daijinkanboukouseikagakuka-Kouseikagakuka/0000173648.pdf
(in Japanese) [accessed Aug. 12, 2022].
- 4. Genda,
K.
2013. Current status survey on physicians’ approaches to clinical trial.
Research Paper Series, Office of Pharmaceutical Research 60: 1–59.
- 5. Stonier, P.
D., Silva,
H. and
Lahon,
H.
2007. Pharmaceutical medicine.
Int. J. Pharm. Med. Res.
21: 253–262.
- 6. The Institute of Drug Development
Career Promotion https://ddcp-med.com/ (in Japanese)
[accessed Aug. 12, 2022].
- 7. Stanley, A.
G., Jackson,
D. and
Barnett, D.
B.
2005. The teaching of drug development to medical students:
collaboration between the pharmaceutical industry and medical school.
Br. J. Clin. Pharmacol.
59: 464–474.
