Points of View Recent Trends in the Utilization of Medical Information as Seen in Pharmaceutical Company News Releases

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Mariko Togashi, Senior Researcher, Pharmaceutical Industry Policy Institute

SUMMARY

1. Introduction

The utilization of medical information is becoming an important strategic tool for pharmaceutical companies to speed up their management and increase their international competitiveness. For example, it can be used as reference information in the design and conduct of clinical trials by utilizing patient health status and past medical information, to gain insight into specific diseases and treatments to develop new drugs and improve existing products, and to formulate product development and marketing strategies that match market trends and patient needs. It can also be used to develop product development and marketing strategies tailored to market trends and patient needs. Furthermore, through partnerships with healthcare organizations, they may contribute to real-time data collection and quality improvement in healthcare. In the past few years, the Personal Information Protection Law has been amended to establish a mechanism for anonymized processed information (effective May 2017) and a mechanism for pseudonymized information (effective April 2022) ²⁾, while the Next Generation Medical Infrastructure Law was enacted (effective May 2018), and furthermore, pseudonymized medical information was created (effective April 2024). (enforced in April 2024) ³⁾. In addition, regulatory changes have been made to utilize medical information for various information collection in post-marketing database surveys and drug safety surveillance, and public awareness activities are being promoted ^{through the} provision of case ^{studies4) , etc.,} creating an environment in which pharmaceutical companies can utilize medical information.

This paper focuses on the current status of utilization of medical information by pharmaceutical companies and investigates specific examples of utilization. The paper clarifies how pharmaceutical companies collect, analyze, and utilize medical information, and also outlines the issues that are expected to arise in the use of medical information in Japan in the future. By presenting actual examples of the utilization of medical information from information published by pharmaceutical companies, we aim to clarify the future prospects for the utilization of medical information from the viewpoint of pharmaceutical companies and to deepen common understanding among various stakeholders.

Survey Methodology

To investigate the latest status of medical information utilization by pharmaceutical companies based on publicly available information, we defined the top 20 companies (in FY2023) in each of the pharmaceutical business sales in the world and Japan as major companies, and closely examined news releases published from FY 2019 to FY2023 on the websites of the countries where their head offices are located. Among them, news releases that reported research (testing) using medical information were selected for the survey, and the location of research, etc. (domestic or overseas), country of data acquisition, data source, data type, and purpose were organized. However, news releases that were intended to provide a summary report of an academic conference presentation, and for which the type of data used and the data source were unclear, were excluded. Also excluded from the selection were clinical trials conducted for the purpose of application for approval, which were judged to have been continued for long-term safety, etc., and published as real-world data. The source of the medical information was counted ^{using the classification5)} organized in Policy Research Institute News No. 72, and the medical information by data type was further classified and organized only for those for which the detailed type was described and understood.

Results

3-1 Number of news releases extracted and countries from which data was obtained

Table 1 shows the number of companies from which news releases were extracted, the number of reports, and the countries from which the data for the studies were obtained.

As a result of the survey, 18 news releases from 7 major Japanese companies and 40 news releases from 13 major global companies were extracted. Given that the purpose of using news releases differs from company to company, the analysis for the extracted cases presented below may not have been able to exhaustively extract the studies, and the possibility of bias in their exact frequency and trends should be taken into consideration.

While we were able to extract a certain amount of news from the world's leading companies regardless of rank, 6 out of 18 reports from domestic leading companies were extracted from the same company and from the top 12 companies, suggesting that the number of domestic leading companies that are actively promoting the use of medical information may be limited.

Nine of the 18 reports from major domestic companies included the use of overseas data. Seven of these cases included the U.S., and three cases used data from multiple countries. The purposes of studies using foreign data included retrospective investigation of the potential for serious adverse events and infections due to the administration of therapeutic agents for the target disease, registry studies for clinical trial design and site selection in the disease area, symptom rating scale studies, health information-based disease prevalence and impact on sleep The first, a retrospective study, collected data on more than 1,000 patients with specific diseases from 42 medical institutions across multiple countries, and the second, a study of the impact of the disease on sleep, using health information to generate data and develop digital solutions to solve problems related to the prediction, prevention, management, and treatment of target diseases. The coordination and handling of medical information with foreign countries is an area that is currently under discussion in Japan. In other cases, the use of health information, new information prospectively obtained through online surveys and digital devices, and combination analysis of already accumulated medical data, etc., were conducted, and the difficulty of linking various types of information and combination analysis in Japan may be part of the reason why these studies have not been conducted in Japan. On the other hand, all of the world's major companies are conducting their research using overseas data.

On the other hand, all of the world's major companies use mainly overseas data, and many of them use data from multiple countries, and among these, three were recognized as including Japanese data. Specifically, there were three studies that investigated the current status and clinical implications of the treatment and management of hyperkalemia on a global scale, a study to investigate the experiences of patients with inflammatory bowel disease (emotional burden, barriers, nursing care experiences and methods of communication with healthcare professionals) to promote understanding of the disease, and a study to investigate the use of The study was a retrospective observational study evaluating first-line afatinib followed by osimertinib. Information was not limited to the country of headquarters of each company, but many studies used data from other countries (17/40 studies, 13/17 studies used data from multiple countries). This indicates that there is a high possibility that these companies make decisions without Japanese information, and it is necessary to construct a medical information infrastructure with a view to linking with overseas information beyond the promotion of the use of domestic medical information to expand opportunities for international collaboration in the Japanese pharmaceutical industry. This is also a challenge.

3-2 Sources of Medical Information

Table 2 shows the results of the classification of sources of medical information. The main sources of medical information were 22 cases (10 from major domestic companies and 12 from major global companies), which were classified as backward-looking information, followed by 20 cases (6 from major domestic companies and 14 from major global companies) of forward-looking medical and biometric information, and 11 cases (0 from major domestic companies and 1 from major global companies) of medical information from database providers (Table 2). The number of cases of medical and biometric information acquired prospectively was 20 (6 from major domestic companies and 14 from major global companies), and 11 from database providers (0 from major domestic companies and 11 from major global companies).

Although under the limited conditions of the news releases extracted in this study, the use of medical information derived from medical institutions was observed in many cases for both domestic and global leading companies, suggesting that there is a high need to use this information for research and that it is an easily accessible route to use.

The global leader had 14 studies that prospectively obtained data, but only one study used a digital device, and most of the studies were clinical studies that collected medical information in medical practice. On the other hand, five of the major domestic companies prospectively acquired daily life information (vitals, activity level, sleep status, etc.) using digital devices, and one used disease-specific information from an online questionnaire survey, and the acquired daily life data were used for analysis and research related to prediction, prevention, management, and treatment of various diseases, as well as for precision The acquired daily life data were used for the purpose of analysis and research on prediction, prevention, management, and treatment of various diseases, as well as research on precision medicine and personalized health care.

Forward-looking information was obtained from two domestic major companies, two from the U.S., one from the U.S. and the U.K., and another from China, while nine of the 14 cases of major foreign companies were obtained from multiple countries.

3-3 Types of data

As shown in Table 3, the types of data actually used in the extracted studies were 46 cases of medical information (10 from domestic major companies and 36 from global major companies), and 6 cases each of health information, genome information, and daily life data (health information: 4 from domestic major companies and 2 from global major companies; genome information: 1 from domestic major companies and 5 from global (health information: 4 from domestic major companies, 5 from global major companies; genome information: 1 from domestic major companies, 0 from global major companies; daily life data: 6 from domestic major companies, 0 from global major companies). Medical data accounted for the majority of the medical information with 17 cases (5 cases from domestic major companies and 12 cases from global major companies), and medical fee data was also used in 10 cases (1 case from domestic major company and 9 cases from global major companies).

As shown in the total data used in Table 3, 26 data were used in 18 studies by the domestic major companies and 46 data were used in 40 studies by the global major companies, indicating that the medical information used in one study was not only a single type of information, but also a combination of multiple types of information that were analyzed Included. There are various patterns, such as combining existing medical data and questionnaire surveys while acquiring new information going forward, or combining genomic information with medical information, imaging information, etc. Specifically, lifestyle data such as sleep status, heart rate, and activity level are acquired and accumulated, and analyzed in combination with already acquired medical data to realize precision medicine and personalized healthcare based on lifestyle and environmental factors, research aimed at enhancing the whole genome reference panel of the general population to discover genotypes that are characteristic of the Japanese population, and Various data utilization is being conducted through various data linkages, including the discovery of characteristic genotypes, and research and development of new drugs and treatments through integrated analysis of genome information, health, and medical information.

Reports on the use of medical reimbursement data have been made by many of the world's leading companies. As examples of reports on the use of overseas data, there were several studies that analyzed and visualized the patient journey of diseases, treatment patterns, medication adherence, and clinical outcomes based on prescription data within reimbursement.

In addition to medical information, several efforts to analyze and study diseases using health information (6 cases: 4 from major domestic companies and 2 from major global companies) and daily life data (6 cases: 6 from major domestic companies and 0 from major global companies) were observed, and these cases were mostly conducted by major domestic companies. Health information was used to expand the genome reference panel, health information and exercise capacity, specific diseases and biologically related factors, and research on the relationship between diseases and environmental, lifestyle, and genetic factors.

The diseases and fields in the extracted studies were wide-ranging, and several studies (seven) were found to be not linked to a specific disease. In Japan in particular, the development of medical information infrastructures in the field of oncology has taken the lead. However, many of the studies conducted by the world's leading companies were in fields in which each company has expertise, and studies in a wider range of diseases were reported, indicating that the scope of application of medical information utilization is not limited to a specific disease.

3-4 Purpose of research and survey

Many cases were found to be used for diagnosis, treatment, and management solutions (21 cases: 5 by major domestic companies and 16 by major global companies), efficacy and safety monitoring (18 cases: 3 by major domestic companies and 15 by major global companies), and disease analysis (12 cases: 6 by major domestic companies and 6 by major global companies) as the purpose of research. There were also several reports of use for database research (6 cases: 2 domestic major companies, 4 global major companies) and research and development of new drugs, tests, and treatments (6 cases: 3 domestic major companies, 3 global major companies).

Differences in the purpose of use were observed between domestic and major foreign companies. The reports from domestic major companies were frequently used for disease analysis and diagnostic/therapeutic/management solutions, while few of them reported studies for post-approval efficacy and safety monitoring as news releases, which were frequently observed in the reports from global major companies. In Japan, it is already recognized that real-world data can be used for safety monitoring under pharmaceutical regulations, but the use of post-marketing efficacy and safety information for promotional purposes is severely restricted, and the benefits of using medical information for this purpose in Japan are limited. The benefits of using medical information for this purpose in Japan are limited. On the other hand, several of the world's leading companies have reported research utilizing medical information for the purpose of evidence generation in news releases intended as summary reports of academic conference presentations, which were excluded from the sampling this time. It is assumed that the use of medical information for this purpose is even more advanced in other countries.

4. discussion of future issues and possibilities based on the current status of recent utilization of medical information

As a result of this survey of studies on the use of medical information published in news releases, the following characteristic trends and examples were observed among major Japanese companies.

First, while the global leaders were able to extract reports on research related to the utilization of medical information regardless of the ranking of the 20 selected companies, the domestic leaders were limited to reports from the top companies, and the number of reports was only about half of those from the global leaders. While this may indicate that the purpose of using news releases differs from company to company and that not enough research has been extracted, it may also suggest that the promotion of medical information utilization in Japan is stagnant. Currently, various measures are being taken to promote the utilization of medical information, and we hope that these measures will be effective.

Second, many cases of positive acquisition of medical information in Japan have been recognized. It appears that there may be a need for information that goes beyond the scope of medical information that has been accumulated to date. The study by the world's leading companies indicates that data can be utilized in a wide range of disease fields, and that it will be necessary to expand the number of institutions that handle medical information in various fields, to expand the use of prospectively acquired data, and to establish and promote a system for mutual collaboration between this information, existing information, and the information held by other institutions. The third is to expand the use of daily life data.

Third, the use of daily life data was recognized in several cases. Not only to grasp and understand the condition of patients not only at the time of examination but also on a daily basis, and to consider more appropriate and efficient treatment plans, but also to predict diseases from health information and to study the relationship between health information and diseases were reported in some studies.

Furthermore, while there were studies to expand domestic databases in this review, it is necessary to establish an appropriate system to appropriately link newly acquired and accumulated data with existing data in the future, given that the information is acquired prospectively and analyzed in conjunction with existing data.

Many of the types of information used were not only single pieces of information, but also multiple types of information or multiple countries combined for analysis and research. In Japan today, there are many institutional issues that make it difficult to link multiple types of data, such as accessibility within public databases and with private registries, personal information protection, etc., and it is assumed that it is difficult to meet this need. It is believed that more flexible utilization can be realized by considering and promoting the linkage of multiple types of data within Japan or even with overseas data.

Conclusion

In the use of medical information, health and medical information, including genome information and Personal Health Record information in addition to information in electronic medical records, can be used by patients themselves for health management, or by medical facilities for primary use in personalized medicine, and by pharmaceutical companies for use of the data accumulated from such use in R&D and safety monitoring of pharmaceuticals and other products. Ideally, the data accumulated from this data should be used by pharmaceutical companies for research and development of pharmaceuticals and safety monitoring, and by the government for medical policy. In Japan, the construction of an environment for deepening the use of medical information is underway, including the consolidation of various public databases centered on the National Database and the development of infrastructure, and progress is being made in creating opportunities for the use of this information by the pharmaceutical industry.

In this report, we review, organize, and analyze news releases from each company in order to understand recent trends in the use of medical information by pharmaceutical companies and the content of their research. Although the extracted information may be biased due to the influence of the purpose of use of each company's news release and other factors, and care must be taken in interpreting the results, we were able to confirm that the current efforts of pharmaceutical companies in the utilization of medical information are wide-ranging. From the results of this survey, the following directions in particular were recognized. First, pharmaceutical companies are emphasizing the diversity and integration of data, including prospective medical information acquisition, and the use of daily life data for disease prediction and treatment optimization. This is expected to enable personalized medical approaches for patients.

In addition, the company is focusing on linking with various databases and integrating data from different sources for more comprehensive analysis. By linking existing data with new information, these efforts could lead to new treatments and medical advances.

However, some challenges are apparent in these efforts. For example, there are issues related to ensuring data quality and integrity when integrating data from different sources, privacy protection issues, and data standardization. In particular, in order to promote appropriate use of data with a view to linking with overseas data without limiting it to domestic data, it will be necessary to consider the legal regulations and ethical frameworks in each country.

In order to promote more effective use of medical information and to promote innovation in the fields of health and medicine, it is expected that the linkage of various types of data will be one of the keys to promote the utilization of medical information by pharmaceutical companies in the future. We hope to see the database be expanded not only to public databases, but also to private registries, and even to overseas.

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