Points of View Recent Trends in Post-Marketing Surveillance and Economic Evaluation of Post-Marketing Database Surveillance

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The Office of Pharmaceutical Industry Research Mariko Togashi, Senior Researcher
The Office of Pharmaceutical Industry Research Natsuko Watanabe, Senior Researcher
The Office of Pharmaceutical Industry Research Makoto Edahiro, Senior Researcher

Summary

1. Introduction

In recent years, Japan has been rapidly developing systems for the utilization of information related to healthcare, medical care, and long-term care with the aim of improving the quality and efficiency of healthcare, as well as creating new medical technologies.

In June 2022, the "Basic Policies for Economic and Fiscal Management and Reform 2022" (approved by the Cabinet on June 7, 2022) ¹⁾ proposed the promotion of medical digital transformation (hereinafter referred to as "medical DX"), and in June 2024, the "Basic Policies for Economic and Fiscal Management and Reform 2024" (approved by the Cabinet on June 21, 2024 In addition, the "Basic Policies for Economic and Fiscal Management and Reform 2024" (approved by the Cabinet on June 21, 2024) ⁽²⁾ clearly stated the development of an environment for secondary use of information shared on the national medical information platform for the development of new medical technologies and drug discovery, and the promotion of data utilization in public databases for medical and nursing care.

In order to promote medical DX, it is necessary to quantitatively evaluate its economic benefits and clarify its economic rationale; the impact assessment ^report3) published in conjunction with the European Health Data Space (EHDS) legislative bill estimated the economic benefits of introducing EHDS This result is an important case study for evaluating the economic benefits of an information infrastructure for health and medical information.

One example of the progress in the secondary use of medical information by Japanese pharmaceutical companies is that DB surveys in post-marketing surveillance have been recognized as a form of post-marketing surveillance by ^the revision of the GPSP ^ordinance4 as of April 1, 2008, and have become a new option in post-marketing surveillance.

This paper focuses on DB surveys, and provides a qualitative and quantitative evaluation of the implementation status and issues of DB surveys in recent post-marketing surveillance of pharmaceuticals, as well as the economic benefits (cost reduction, operational efficiency, etc.) of shifting from conventional drug use-results surveys to DB surveys, and looks at the significance of DB surveys in promoting the utilization of medical information and their potential for future use. The significance of DB surveys in promoting the utilization of medical information and their potential for future use will be discussed.

Survey Methodology

2-1 Investigation of the current status of post-marketing surveillance, etc.

To investigate the current status of drug use-results surveys and DB surveys in post-marketing surveillance from publicly available information, from the RMP (as of April 2025) in the list of new drug approval ^items5) listed on the website of the Pharmaceuticals and Medical Devices Agency (hereinafter, PMDA) for fiscal 2020 to 2024 (five fiscal years), The existence and content of additional drug safety surveillance activities were investigated, and investigations planned as a result of approvals and partial change approvals (hereinafter referred to as "single change") were identified and extracted. The survey items were the number of new drug items approved, the number of initial RMPs and the number of investigations newly established as a result of approval, and the information was organized according to the following criteria.

2-2 Economic evaluation when using DB surveys

The flow of conventional use-results surveys and DB surveys were organized, and cost estimates were made for the work involved in each process. The cost reduction effect over a five-year survey period was estimated based on the rate at which the use-results survey could be transferred to the DB survey.

Results

3-1 Results of Post-Marketing Surveys, etc.

3-1-1 Background Information on New Drugs Approved in FY2020-2024

First, as background information, Table 1 shows the number of new drug approvals and the number of items for which an initial RMP was established for each fiscal year for five years, and Table 2 shows the number of items by PMDA review field.

The number of new drug approvals per fiscal year remained mostly unchanged between 123 and 146, with some increase or decrease from FY2020. Orphan drugs were unevenly distributed by year, but ranged from 26 to 36 items, accounting for 22.9% of the total number of approvals for the entire target period. The number of initial RMPs was 37.0% of the total number of approvals for the entire period under review, and as with the number of approvals, the trend over the five-year period remained almost unchanged. Most products containing new active ingredients (220/225 approvals) and other drugs had initial RMPs in 27.8% (25/90 approvals) of the total number of approvals during the period under review, although the percentage varied depending on the year.

The number of new drug approvals by PMDA review field showed that 30.9% were in the antimalarial field, 11.8% in the first field, and 10.7% in the sixth field (1). The review fields handled by PMDA's New Drug Review Division are shown in Table 3.

3-1-2 Breakdown of post-marketing surveillance

Table 4 shows the number of post-marketing surveillance investigations planned as a result of approval or a change in each fiscal year, and Figure 1 shows the percentage change in the number of investigations for each category. The total number of investigations decreased from around 80 in FY2023 to 47 in FY2024.

Looking at the details, the highest number of surveys was conducted in specific use-results surveys, followed by general use-results surveys and DB surveys. The number of surveys for general use-results surveys and specific use-results surveys decreased in FY2024, while that for DB surveys remained unchanged. Looking at the ratio of the number of surveys for each survey, the number of surveys for specific use results remained in a decreasing trend in the same fiscal year, while the number of surveys for general use results remained unchanged, and the number of DB surveys remained flat at around 10% from FY2020 to FY2023, but increased to 25.5% in FY2024.

In order to further investigate the current status of post-marketing surveillance from various perspectives, we counted (1) the number of all investigations, (2) the types of investigations for orphan drugs, (3) the number of investigations by PMDA review field, (4) the case size of each investigation, and (5) the presence of a control group.

All-case surveillance accounted for 27.0% of all post-marketing surveillance. The number of all post-marketing surveillance surveys remained unchanged until FY2023, but showed a decreasing trend (13 surveys) in FY2024. On the other hand, looking at the movement of each survey in terms of percentage, a remarkable increase (44.4%) was observed especially in the specific use-results survey. While all-case surveys are planned in the conventional general and specific-use surveys, some DB surveys also supplemented all cases (1 survey). Specifically, the TRUMP-GVHD registry was used for chronic graft-versus-host disease after hematopoietic stem cell transplantation in Lezrock. (Table 5)

Post-marketing surveillance for orphan drugs accounted for 120 of the total 374 investigations, or approximately 32.1%. Although general and specific use-results investigations accounted for a high percentage of investigations for orphan drugs, DB investigations were also selected in 7 (5.8%) of the investigations. Specifically, the following products were surveyed: 4 investigations for a single change and 3 investigations for the approval of a new active ingredient. In addition, three investigations were included for graft-versus-host disease after hematopoietic stem cell transplantation as an indication. (Table 6)

Looking at the number of investigations by field of review, the total number of investigations was highest for Anti-Malignant (98 investigations), No. 1 (53 investigations), and No. 6-1 (52 investigations), in that order. On the other hand, the number of DB surveys was in the order of No. 1 (11 surveys), No. 6-1 (10 surveys), and No. 2 and Anti-virus (9 surveys each). In addition, only DB investigations were conducted for biotechnology, while AIDS and the 5th had zero DB investigations throughout the five years. The third one, the fourth, and the sixth two have a considerable number of surveys, but only one DB survey, indicating a low percentage of DB surveys. (Table 7, Figure 2)

Looking at the size of the number of cases in post-marketing surveys, 58.0% and 63.2% of the general and specific use results surveys were conducted with 300 cases or less, respectively, and almost 70% or more were conducted with 500 cases or less. On the other hand, DB surveys were used for a wide range of surveys from less than 300 cases to more than 10,000 cases, and many DB surveys were under review or the number of cases was unknown. The reasons for this were that the policy for conducting DB surveys had been decided, but the detailed plans were still under consideration. In addition, the plans for unknown number of cases in conventional surveys are mainly plans for all-case surveys. (Table 8, Figure 3)

Regarding whether or not a control group was established in post-marketing surveys, it is not expected that a control group would be established in general and specific use-results surveys, while a control group was established in 36 of the total 50 DB surveys (72.0%). (Figure 4)

3-1-3 Breakdown of DB Surveillance

In order to further investigate the DB survey, we surveyed the types of databases actually used, and the percentages are shown in Figure 5.

Medical Data Vision ("MDV") was the most common database used, followed by Medical Information Database Network ("MID-NET") and JMDC, with these three types accounting for approximately 50% of the total. Several unidentified surveys were also recognized during the study. Several registries are also being utilized, and when added together, account for the same percentage as MID-NET. The registries utilized were specifically TRUMP-GVHD, PIDJ2, and CIRCLe. The contents of each registry are shown below.

TRUMP-GVHD: An electric data capture system (EDC system) ⁶⁾ designed to collect detailed clinical follow-up information on graft-versus-host disease (GVHD), a complication after allogeneic hematopoietic cell transplantation. PIDJ2

PIDJ2: Genetic analysis and patient registry for primary immunodeficiency, autoinflammatory diseases, and early-onset inflammatory bowel ^disease7).

〈CIRCLe〉A multicenter prospective registry study of childhood-onset liver ^diseases8).

Table 9 and Fig. 6 show the percentage of pharmaceutical companies planning to conduct the DB study and the number of companies conducting the study in the category of foreign- and domestic-capitalized companies, respectively. The breakdown of domestic/foreign capitalization was 228 (61.0%) foreign-capitalized and 146 (39.0%) domestic-capitalized out of the 374 surveys, but the proportion of DB surveys (50 surveys in all) was 35 (70.0%) foreign-capitalized and 15 (30.0%) domestic-capitalized, indicating that more foreign companies are planning to conduct DB surveys than domestic companies. The number of DB surveys conducted by each company is as follows. Looking at the number of DB surveys conducted by each company, many companies plan to conduct more than one survey per company, and 10 companies plan to conduct three or more surveys.

3-2 Economic Evaluation of Utilizing DB Surveys

3-2-1 Post-Marketing Surveillance Flow and Items Related to Economic Evaluation

Figure 7 shows the flow of conventional use-results surveys. Conventional use-results surveys start with the development of a survey plan and proceed mainly through the process of site selection, contracting, case enrollment, survey form collection, data management, statistical analysis, and medical writing. In a DB survey, on the other hand, the process from facility selection to data management in a conventional use-results survey is replaced by data extraction from a database.

The survey planning process in a conventional drug use-results survey can be planned based on past experience in drug use-results surveys, so the workload is light and can be accomplished in a short period of time. In contrast, DB surveys are more difficult because there is little accumulated experience and it is necessary to examine the design, the certainty of outcome settings, and the existence of data on a product-by-product basis. In addition to database selection, contracts with database providers, and meetings for planning, the PMDA is usually consulted in the formulation of an appropriate plan, which requires a reasonable preparation period. On the other hand, while the survey planning process in a conventional drug use-results survey must basically be completed promptly after approval, the DB survey only needs to be completed by the time data are extracted for statistical analysis, allowing more time to be allocated for survey planning than in a conventional drug use-results survey.

Conventional use-results surveys require contracts with medical institutions requesting surveys and monitoring operations on a facility-by-facility basis, which require continuous workload, manpower, and man-hours throughout the entire survey period. If this work is done in-house, the man-hours of MRs in charge of each facility at pharmaceutical companies are used. In recent years, some companies have outsourced this work to contract research organizations (CROs), which incur outsourcing fees and therefore external costs. In recent years, surveys using EDC systems have become the mainstream, and in this case, the initial setup and operation costs of the system are incurred. In addition, medical institutions are required to pay fees, expenses, and other costs for conducting surveys.

Medical institutions are also burdened with the manpower and man-hours required to conduct the survey. In particular, physicians in charge are burdened with the task of preparing survey forms.

In contrast, the costs associated with DB surveys are mainly database usage fees for data extraction, and do not include the workload at medical institutions, EDC systems, compensation to medical institutions, and other costs. In many cases, database providers do not include statistical analysis and medical writing in the scope of their contracted services, so if these services are to be outsourced, it is necessary to separately select and contract with an outsourcing company. However, the outsourcing of this process is not considered to be significantly different from the scope of conventional post-marketing surveillance.

3-2-2 Cost Benefit Estimation

This section compares the economics of conventional post-marketing surveillance with those of DB surveys. In the evaluation, it was assumed that there would be no significant changes in man-hours for statistical analysis and medical writing, in-house personnel costs, and outsourcing costs in the post-marketing surveillance process, and the difference in costs required for other processes was considered to be the cost advantage. The economic evaluation of the use of DB surveys over multiple years was estimated by multiplying the proportion of tests that could be replaced by DB surveys. In this chapter, in addition to cost items for which money is actually exchanged, we have also estimated in monetary terms, to the extent possible, non-monetary elements of resource consumption that cannot be ignored, such as the workload at medical institutions.

Cost of conventional post-marketing surveillance

We estimated (1) survey costs to be paid to medical institutions, (2) staff man-hours at medical institutions, (3) monitoring costs to medical institutions, and (4) EDC system setup costs. It should be noted, however, that these items are limited to specific operations that can be surveyed and estimated, and that the basic unit used is an average value within the scope of the survey and a trial calculation using representative indicators.

(1) Investigation fees paid to medical institutions

Referring to the National Hospital Organization's "Guidelines for Calculating Contract Research Expenses, " ⁹⁾ the amount of compensation (including administrative and management costs) to medical institutions per survey form preparation is assumed to be 28,600,000 yen for a general use-results survey and 42,900,000 yen for a specific use-results survey. According to the Japan Pharmaceutical Manufacturers Association's Pharmacovigilance Committee (hereafter referred to as "PV Committee"), the percentage of investigations with a separate volume is reported to account for approximately ^55%10). Assuming that two investigation forms are prepared for 55% of cases, the investigation cost for one study for each scale of 300, 1,000 or 3,000 cases is estimated as follows The cost of one study for 300, 1,000, or 3,000 cases, respectively, was estimated as follows.

(2) General use-results survey

2.86 million yen x (300 cases + 300 cases x 0.55)
= 13,299,000 yen
2.86 million yen x (1,000 cases + 1,000 cases x 0.55)
= 44.33 million yen
2.86 million yen x (3,000 cases + 3,000 cases x 0.55)
= 132.99 million yen

(1) General use-results survey (2) Specified use-results survey

4.29 million yen x (300 cases + 300 cases x 0.55)
= 1,994.85 million yen
4.29 million yen x (1,000 cases + 1,000 cases x 0.55)
= 6,649.5 million yen
4.29 million yen x (3,000 cases + 3,000 cases x 0.55)
= 199,485,000 yen

In addition, the amount of remuneration will be even higher for investigations involving complex work. In addition, if additional survey forms need to be prepared after the third report, additional costs will be incurred for the above unit costs.

(2) Staff man-hours at medical institutions

We estimated the cost of preparing a survey form as a typical task for medical institution staff, assuming that the average number of items on a survey form is reported to be 76 by the PV ^{subcommittee11)} and that each item takes about one hour to prepare, assuming less than one minute per item. The average hourly wage for physicians was calculated from the 2024 Basic Survey on Wage ^Structure12), which indicates the amount of salary per working hour, to be approximately 7,700 yen (hospital size total of 100-999 employees, 1,214,600 yen/157 prescribed actual working hours). However, this salary amount does not take into account allowances and bonuses, nor does it assume overtime work.

7,700 yen x 1 hour x (300 cases + 300 cases x 0.55)
= 3,580,500,000 yen
7,700 yen x 1 hour x (1,000 cases + 1,000 cases x 0.55)
= 1,193,500,000 yen
7,700 yen x 1 hour x (3,000 cases + 3,000 cases x 0.55)
= 35,850,000 yen

(iii) Monitoring costs for medical institutions

In conventional drug use-results surveys, when contracting with medical institutions and monitoring services are performed in-house, it is common practice to allocate the man-hours of MRs in charge of each facility to perform these services. Since CRO outsourcing costs are estimated based on various factors such as the complexity of the survey plan, the scale of the survey, the number of medical institutions, the duration, and the nature of the outsourced work, it was difficult to obtain concrete information with a wide range of costs disclosed publicly, so based on the information obtained through interviews with experts, we estimated that the main costs were monitoring costs Therefore, based on the information obtained from interviews with experts, we concluded that the cost was about 100 million yen (assuming a case size of 300 cases), which was mainly for monitoring and project management. This cost does not take into account travel expenses for facility visits, which would be even higher if the number of cases increased.

(4) EDC system setup fees

The cost was estimated as follows, referring to the price ^{information13)} of Fujitsu FIP's PostMaNet, which claims the top share of the domestic PMS/EDC system market as a post-marketing surveillance data collection system. However, we used the reference price in the company's 2014 press release and assumed a monthly fee of 500,000 yen for 499 cases or less, and a standard product reexamination period of 8 years. Since the initial cost was quoted on an individual basis, we compared the costs of three other EDC systems for clinical development for which prices were publicly available, and chose the lowest price of 1.2 million yen.

Initial cost 1.2 million yen + operating cost 500,000 yen x 12 months x 8 years
= 49.2 million yen

Cost of DB surveys

Consultation fees with PMDA (drug database/registry reliability survey consultation and epidemiological survey planning consultation) ^{14) and} database usage fees were investigated.

(i) Consultation fee with PMDA

Database usage fees

Of the databases that have been used for the DB survey, we referred to the MID-NET usage ^fees15) for which usage fees are publicly available.

Cost Benefit Estimation Based on the Past 5 Years of Post-Marketing Surveys

The conventional use-results survey cost, DB survey cost, and cost benefit were estimated as follows, assuming a case size of 300 cases, a survey period of eight years during the normal reexamination period, and one PMDA consultation for each of the two types.

Summary and Discussion

4-1 Recent Trends in Post-Marketing Surveillance

The ratio of the number of initial RMPs to the number of new drug approvals from FY2020 to FY2024, when the survey was conducted in this report, was 37.0%. The breakdown was dominated by drugs containing new active ingredients, with several approved in each year for other products.

Looking at the trend of newly planned surveys due to approvals, the total number of surveys showed a sharp decline in FY2024. Since there was no significant change in the overall number of approved products, especially in new active ingredients, nor in the number of initial RMP formulations, each of these decreases in the number of investigations was caused by a review of the way post-marketing surveillance should be conducted in the "How to proceed with the study on formulating a plan for conducting post-marketing surveillance of pharmaceutical products" (hereinafter referred to as the "Decision Tree Notice"), The decrease in the number of these surveys can be assumed to be due to the impact of the issuance of the "Notice of Partial Revision of the "Decision Tree Notice" (hereafter referred to as the "Decision Tree Notice" ¹⁷⁾. Under such circumstances, the number of DB surveys that appear to have leveled off as a numerical value is increasing as a percentage, and the way in which each survey is selected may be changing.

On the other hand, the number of surveys of all cases remained unchanged as a percentage, although a decline in the number of surveys was observed due to the decrease in the total number of surveys. However, the breakdown shows a decrease in the proportion of all investigations in general use performance surveys and an increase in the proportion of all investigations in specific use performance surveys. The revision of the decision tree notification has led to a major review of all-case surveillance, and it is possible that all-case surveillance will either decrease or be limited to a specific range of cases. There are also plans to conduct all-case surveys in DB surveys, and depending on the database and disease selected (at present, there is a high possibility of conducting all-case surveys for rare diseases), there is a possibility of conducting all-case surveys in DB surveys. It is expected that the development and coordination of various public databases and registries will expand the possibilities for such a response in the future.

Of the post-marketing surveillance for orphan drugs among newly approved drugs, 7 surveys (5.8%) were DB surveys. There is a possibility that the database may be used to supplement clinical trials for rare diseases, which tend to remain on a small scale. In addition, the database may facilitate the planning of the next DB study by providing a history of plans for the same product with the same efficacy.

Looking at each PMDA review field, it can be said that the number of surveys is high mainly in the review section where the number of approved items is large, while there are some fields where the percentage of survey instructions is relatively small. In particular, in the fifth field, although 37 products have been approved, there are only two investigations on general use results. The number of DB investigations shows that the percentage of investigations conducted varies by field. The reasons for this may include differences in the level of acceptance by the PMDA, the tendency of pharmaceutical companies to actively utilize databases in their development fields, and the suitability of the application of DB surveys for each disease.

In terms of case size, the largest number of general and specific-use surveys (approximately 60%) involved less than 300 cases, and no survey involving more than 10,000 cases was found. On the other hand, a wide range of case numbers was set for DB surveys, and the tolerance for the number of cases was remarkable. In contrast to conventional use-results surveys, where the number of cases tends to be proportional to the increase in workload and cost, DB surveys do not have a large impact on workload and cost due to the size of the case population, which is one of the reasons for selecting DB surveys. However, there are many surveys in which the number of cases is under review or unknown, and it is unclear whether they reflect the actual proportion of cases. Therefore, it appears that the plan, including the number of cases, is being finalized by the time the data is extracted according to the evaluation period.

In addition, the setting of a control group is not expected in conventional use-results surveys, but on the other hand, a high percentage (72.0%) of DB surveys had a control group. The ease of implementing a large-scale survey with a control group is an advantage unique to DB surveys.

The types of databases used were very limited, including commercial databases such as MDV and JMDC, MID-NET, and three disease-specific registries. These databases are collected by individual database providers, and each has its own characteristics and limitations in terms of target population, stored information, and structure. We hope that the establishment of various public databases and the consolidation of medical information, which the authorities are promoting, will increase the number of databases that can be selected for DB surveys and promote their utilization.

This can be interpreted as an indication of the difference in selection between domestic companies with expertise in conventional post-marketing surveillance in Japan and foreign companies with expertise in the utilization of foreign medical data. In addition, the fact that companies planning to conduct DB surveys are doing multiple plans within a single company suggests that there is a high barrier to selecting a DB survey for the first time.

4-2 Economic Evaluation of DB Surveys

In this paper, as an example of evaluating the economic benefits of utilizing medical information, we estimated the economic evaluation (cost benefits) of utilizing DB surveys. As a result, it was estimated that there would be a cost benefit of 123 million yen per study in a 300 case study. Based on this figure, the economic effect of shifting from conventional use-results surveys to DB surveys was calculated to be approximately 9.2 billion yen over five years.

It should be noted, however, that these estimates are subject to a number of limitations. For one thing, the estimates we were able to present in this paper are limited, and the actual costs will vary greatly depending on various conditions, including the type and scale of the study, complexity of content, duration, monitoring method, number of consultations, and databases to be used. In addition, especially for products with a large number of safety study items ("SS"), SS that can be confirmed in one conventional drug use-results survey are not necessarily captured in one DB survey.

On the other hand, MHLW working groups and PV subcommittees have reported that there are cases in which conventional use-results surveys can be substituted by DB surveys, suggesting that there may be products for which DB surveys are applicable but do not fully utilize this advantage. In this report, estimates were made based on the report of the MHLW working group, and the percentage of conventional use-results surveys that could have been conducted by DB surveys in the FY2024 activities of the PV Subcommittee was 23.3% (4.9% for surveys in which all SS could be covered by DB surveys, 18.3% for surveys in which only some SS could be covered by DB surveys, and 18.3% for surveys in which only some SS could be covered by DB surveys). The percentage of surveys that could be shifted to DB surveys is an issue for further study ^. However, these estimated ratios do not include surveys of all cases and surveys of orphan drugs. The survey results in this paper indicate that DB surveys have been conducted especially for orphan drugs, the possibility that the scope of all-case surveillance will be narrowed down due to the revision of the decision tree notification based on the review of post-marketing surveillance conducted last fiscal year, and the possibility that the number of databases and registries that can be utilized will increase due to the promotion of the development and validation of various databases. The utilization rate of DB surveys is expected to increase in the future, as the number of databases and registries that can be utilized is expected to increase and the range of SS that can be evaluated is expected to expand due to the development of various databases and the promotion of validation.

Conventional use-results surveys are usually conducted on the scale of 300 cases, but DB surveys can be conducted on the scale of several thousand cases and can include a control group, which may lead to a different selection situation in the first place.

In light of the above, the necessity of additional safety surveillance activities based on decision tree notification and the selection of post-marketing surveillance should be optimized according to the characteristics and objectives of each product, and it is not possible to replace all conventional drug use-results surveys with DB surveys. Therefore, it is not possible to replace all conventional post-marketing surveillance with DB surveys. It was considered important to understand these characteristics and advantages, and then make a choice that maximizes the cost advantages of DB surveys.

5. Conclusion

In Japan, while medical DX is progressing, there has not been sufficient research and studies on its effectiveness and estimation procedures, and only individual examples and other information have been presented. In this paper, we focus on the economic benefits of pharmaceutical companies' utilization of medical information by building a medical information infrastructure, which is the key to the promotion of medical DX that has been promoted in Japan in recent years, and examine the status of utilization of DB surveys in post-marketing surveillance as a representative example.

Although DB surveys of pharmaceuticals have been a form of post-marketing surveillance recognized by the authorities since 2018, even at this point, it is difficult to say that the utilization of DB surveys has progressed sufficiently. This is due to the following reasons: the survey of all cases still accounts for a certain percentage, the currently available databases are very limited, and there are insufficient databases that ensure the level of reliability required for regulatory compliance, enable continuous and long-term follow-up, and have been developed for obtaining consent for utilization. There are also several issues such as the insufficiency of validated databases required for utilization, and the fact that utilization by pharmaceutical companies is limited to a certain range of companies, resulting in biased utilization capabilities and know-how.

On the other hand, the results of the trial calculations indicate that the utilization of DB surveys can reduce the burden of post-marketing surveillance under certain conditions, in other words, that there are economic benefits to be gained from the utilization of DB surveys. This fact gives meaning to the selection of DB surveys in the future, taking appropriate situations into account.

Although this report focuses on post-marketing surveillance, the economic impact of various activities in the promotion of medical DX and the economic evaluation will contribute to the consideration, understanding, and grasping of the significance of medical information utilization, raising the awareness of various stakeholders, and promoting common understanding, which in turn will contribute to the promotion of medical DX in Japan. This will contribute to the promotion of medical DX in Japan. It is also considered to be one of the triggers that will promote proactive efforts to address issues in the promotion of DX. We hope that pharmaceutical companies will actively utilize medical information and that the regulatory authorities and related research institutions will continuously evaluate the economic efficiency and verify the effectiveness of the utilization of medical information so that it will be effective in the future.

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