書誌事項
- タイトル別名
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- A Questionnaire Survey of Pharmaceutical Companies Affiliated with Japan Pharmaceutical Manufacturers Association on Current Use of Big Data/Real-World Data for Drug Development in Japan
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説明
<p>Background: The use of big data/real-world data (BD/RWD) is expected to be a new option for evidence generation in drug development. Pharmaceutical companies are considered to be a group of key drivers to promote widespread use of BD/RWD in Japan. However, little is reported about the current status of the use of BD/RWD for drug development in Japan.</p><p>Objective: This study was conducted to reveal the current usage of BD/RWD by pharmaceutical companies in Japan and their current organization structure, with the aim to gain insight on the challenges and future perspective of BD/RWD in Japan.</p><p>Methods: A questionnaire survey was conducted on 66 pharmaceutical companies affiliated with Japan Pharmaceutical Manufacturers Association from 16 to 31 October 2018. The survey consisted of two parts: Questionnaire 1 investigated the current usage of BD/RWD in drug development in Japan, and Questionnaire 2 investigated the current organization structure.</p><p>Results: Of 52 companies that responded to Questionnaire 1, 30 companies (57.7%) were currently using BD/RWD for drug development in Japan for various purposes, 29 of which (96.7%) planned to continue using BD/RWD. Of 28 companies that responded to Questionnaire 2 and currently using BD/RWD, 9 companies (32.1%) had established divisions or organizations for internal management of BD/RWD, and 14 companies (50.0%) had standard operation procedures or guidance for handling legal and regulatory aspects associated with the use of BD/RWD for drug development in Japan.</p><p>Conclusion: BD/RWD is currently used for various purposes in drug development in Japan. However, the proportion of companies currently using BD/RWD for drug development is limited to approximately 50%. Proactive involvement of pharmaceutical companies toward the use of BD/RWD for drug development in Japan together with further industry-government-academia harmonization for environment improvement are awaited.</p>
収録刊行物
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- 臨床薬理
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臨床薬理 50 (4), 167-175, 2019-07-31
一般社団法人 日本臨床薬理学会
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詳細情報 詳細情報について
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- CRID
- 1390845713088491008
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- NII論文ID
- 130007695201
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- ISSN
- 18828272
- 03881601
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- 本文言語コード
- ja
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- データソース種別
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- JaLC
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