Drug Evaluation Committee Report on the Actual Situation and State of Database Research in Medical Affairs

Medical Affairs Subcommittee

January 2024

In order to understand the current status of efforts related to observational research, including database research, as MA activities, a study was conducted based on the results of a questionnaire survey conducted from June to July 2021 among 61 member companies of the MA Committee of the Pharmaceutical Manufacturers Association of Japan (PMAJ). The report was published on the website of the Pharmaceutical Manufacturers Association of Japan (PMAJ) in February 2023.
The report is diverse and voluminous, so we have prepared a slide presentation entitled "Key Points of the Report on the Current Status and Future of Database Research in Medical Affairs" from which the main points are excerpted. The slides are composed of two parts: 1) "Systematic Construction and Points to Keep in Mind Concerning Database Research" and 2) "Information Relevant to Practical Responses.
We hope that these reports and slides of key points will be widely used by pharmaceutical companies, contract research organizations (CROs), and others involved in MA-related DB research in various training sessions and in explaining and organizing the overview and key points, thereby deepening their understanding of the actual status of MA-related DB research and how it should be handled in the future. We hope it will help those affiliated with MA to deepen their understanding of the actual status of DB research in MA and how to respond to it in the future.
If you wish to modify the content of the key point slides, please make sure to clearly identify the parts of the report and the key point slides that are quoted.

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