建置國家級人體生物資料庫整合平台

技術摘要

本計畫目標為建置國家級人體生物資料庫整合平台，建立一致化的品質標準，並代為廣做宣傳，媒介全台灣產學研界來申請運用，成為台灣最重要的生醫研究資源，並對於活絡台灣現有之人體生物資料庫運作將大有助益，未來並可吸引國外研究機構或產業界的興趣，有助於建立與國際學術機構或生技產業合作關係。

This project has successfully established National biobank consortium of Taiwan (NBCT) through the fund support and governance from the government. Currently NBCT already includes 37 biobanks and has more than 989 thousand participants. So far, NBCT already received 184 applications, including 32 from industries.One of them is an international collaboration project and application from Roche. The number of specimens in the NBCT is very large, coupled with large medical data, it is already Taiwan's largest biomedical industry resource.

技術內容

台灣的人體生物資料庫（biobank）最早自2003年由中研院開始規畫成立，2010年通過《人體生物資料管理條例》後，多家biobank相繼成立，截至2024年7月，台灣已有37家機構建置了經衛生福利部核可的人體生物資料庫。由於台灣已有「人體生物資料庫管理條例」，可以合法取得病患授權使用其檢體和醫療資訊以及串連國內其他資料庫(broad consent)，此法律對人體生物資料庫有嚴格的個資管控規範，以及商業利益回饋條款，不只可以提供高品質的醫療資訊和檢體給學術界使用，也可以合法的讓產業界提出申請及商業運用。這是人體生物資料庫最大利基，因此非常值得好好加以運用。應該提升其使用效率，以發揮其最大效用。2018 BTC總結建議：醫療資料與生物資料庫整合，應強化、串連、整合醫療或健康相關資料庫及大數據平台，例如健保資料庫、Biobank等，使其成為我國發展數位醫療之強大磐石。國家級人體生物資料庫整合平台(下稱整合平台)因此於2019年10月30日正式成立，並委由國家衛生研究院建立中央辦公室負責所有行政業務。整合平台的目標是1. 讓全國biobanks能合作運用檢體及相關資訊，提升運用效益。2. 完善台灣人體生物資料庫之管理規範，促使biobank檢體與相關資訊品質一致化。3. 結合檢體的加值運用，建立龐大完整的基因與醫療大數據，符合生技製藥，人工智慧，輔助醫療等產業界的需求，提升其生醫研究價值。在2019迄2024年間，整合平台已成功邀集37家人體生物資料庫加入，總登錄案例數達98.9萬，建立12個檢體申請及運用的SOP，以及建立醫療數據共同資料欄位(CDM)。並為所有biobank 廣做宣傳，媒介全台灣產學研界來申請運用，至今已有184 件申請案，包含32件產業界申請案。整合平台37家人體生物資料庫的檢體數量十分龐大，加上大型醫療數據，已是一個台灣最大生醫產業寶藏。未來規劃是擴大檢體加值運用，並在兼顧資訊安全以及符合biobank法規下，開啟雲端服務，讓申請人可以上網分析及運用數據，有利於促成國際合作，讓整合平台的成果效益，繼續擴大，成為台灣生技醫藥產業的最重要資源。並可吸引國外研究機構或產業界的興趣，有助於建立與國際學術機構或生技產業合作關係。

Through the cooperation of all biobanks in Taiwan, with consistent quality standards and clinical data content, a large and comprehensive human biobank network can be quickly established. As a result, National Biobank Consortium of Taiwan (NBCT) was established. The goal of NBCT is to promote the biomedical science in Taiwan and the demand of biotechnology industries. A Central office of NBCT was set up to manage all of the administration work and to play a role as one stop service with good efficiency. Adequate and consistent clinical data will also be established under well information security management. Since the contents of the biobanks from different institute are quite different, NBCT is able to quickly establish a large and comprehensive biobank network. Currently NBCT already successfully invited 37 biobanks to join and has more than 989 thousand participants with various kinds of biosamples available for applicants. So far, NBCT already received 184 applications, including 32 from industries. One of them is an international collaboration project and application from Roche. The number of specimens in the NBCT is very large, coupled with large medical data, it is already Taiwan's largest biomedical industry treasure. The future plan is to expand information security and compliance with biobank regulations, so that applicants can analyze and use data online, which will help promote international cooperation and continue to expand the results and benefits of the integrated platform, becoming the most important resource for Taiwan's biotechnology and pharmaceutical industry. It can also attract the interest of foreign research institutions or industries, and help establish cooperative relations with international academic institutions or biotechnology industries.

團隊簡介或技術聯絡人