{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,4,30]],"date-time":"2026-04-30T05:25:56Z","timestamp":1777526756610,"version":"3.51.4"},"reference-count":28,"publisher":"China Science Publishing & Media Ltd.","issue":"4","license":[{"start":{"date-parts":[[2021,7,26]],"date-time":"2021-07-26T00:00:00Z","timestamp":1627257600000},"content-version":"vor","delay-in-days":206,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":["direct.mit.edu"],"crossmark-restriction":true},"short-container-title":[],"published-print":{"date-parts":[[2021,10,25]]},"abstract":"<jats:p>The FAIR data guiding principles have been recently developed and widely adopted to improve the Findability, Accessibility, Interoperability, and Reuse of digital assets in the face of an exponential increase of data volume and complexity. The FAIR data principles have been formulated on a general level and the technological implementation of these principles remains up to the industries and organizations working on maximizing the value of their data. Here, we describe the data management and curation methodologies and best practices developed for FAIRification of clinical exploratory biomarker data collected from over 250 clinical studies. We discuss the data curation effort involved, the resulting output, and the business and scientific impact of our work. Finally, we propose prospective planning for FAIR data to optimize data management efforts and maximize data value.<\/jats:p>","DOI":"10.1162\/dint_a_00106","type":"journal-article","created":{"date-parts":[[2021,7,26]],"date-time":"2021-07-26T16:15:33Z","timestamp":1627316133000},"page":"631-662","update-policy":"https:\/\/doi.org\/10.1162\/mitpressjournals.corrections.policy","source":"Crossref","is-referenced-by-count":12,"title":["Implementation of the FAIR Data Principles for Exploratory Biomarker\n                    Data from Clinical Trials"],"prefix":"10.3724","volume":"3","author":[{"given":"Alexander","family":"Arefolov","sequence":"first","affiliation":[{"name":"Rancho BioSciences LLC., San Diego, CA 92127, USA"}]},{"given":"Laura","family":"Adam","sequence":"additional","affiliation":[{"name":"Rancho BioSciences LLC., San Diego, CA 92127, USA"}]},{"given":"Shoshana","family":"Brown","sequence":"additional","affiliation":[{"name":"Rancho BioSciences LLC., San Diego, CA 92127, USA"}]},{"given":"Yelena","family":"Budovskaya","sequence":"additional","affiliation":[{"name":"Rancho BioSciences LLC., San Diego, CA 92127, USA"}]},{"given":"Cong","family":"Chen","sequence":"additional","affiliation":[{"name":"Rancho BioSciences LLC., San Diego, CA 92127, USA"}]},{"given":"Diya","family":"Das","sequence":"additional","affiliation":[{"name":"Development Sciences Informatics, Genentech Inc., South San Francisco, CA 94080-4990, USA"}]},{"given":"Chen","family":"Farhy","sequence":"additional","affiliation":[{"name":"Rancho BioSciences LLC., San Diego, CA 92127, USA"}]},{"given":"Rebecca","family":"Ferguson","sequence":"additional","affiliation":[{"name":"Rancho BioSciences LLC., San Diego, CA 92127, USA"}]},{"given":"Hongmei","family":"Huang","sequence":"additional","affiliation":[{"name":"Development Sciences Informatics, Genentech Inc., South San Francisco, CA 94080-4990, USA"}]},{"given":"Kimberly","family":"Kanigel","sequence":"additional","affiliation":[{"name":"Rancho BioSciences LLC., San Diego, CA 92127, USA"}]},{"given":"Christina","family":"Lu","sequence":"additional","affiliation":[{"name":"Development Sciences Informatics, Genentech Inc., South San Francisco, CA 94080-4990, USA"}]},{"given":"Oksana","family":"Polesskaya","sequence":"additional","affiliation":[{"name":"Rancho BioSciences LLC., San Diego, CA 92127, USA"}]},{"given":"Tracy","family":"Staton","sequence":"additional","affiliation":[{"name":"Development Sciences OMNI-Biomarker Development, Genentech Inc., South San Francisco, CA 94080-4990, USA"}]},{"given":"Rajeev","family":"Tajhya","sequence":"additional","affiliation":[{"name":"Rancho BioSciences LLC., San Diego, CA 92127, USA"}]},{"given":"Maryann","family":"Whitley","sequence":"additional","affiliation":[{"name":"Rancho BioSciences LLC., San Diego, CA 92127, USA"}]},{"given":"Jee-Yeon","family":"Wong","sequence":"additional","affiliation":[{"name":"Development Sciences Informatics, Genentech Inc., South San Francisco, CA 94080-4990, USA"}]},{"given":"Xiangpei","family":"Zeng","sequence":"additional","affiliation":[{"name":"Rancho BioSciences LLC., San Diego, CA 92127, USA"}]},{"given":"Mark","family":"McCreary","sequence":"additional","affiliation":[{"name":"Development Sciences Informatics, Genentech Inc., South San Francisco, CA 94080-4990, USA"}]}],"member":"2026","published-online":{"date-parts":[[2021,10,25]]},"reference":[{"key":"2021102516595617800_ref1","volume-title":"A digitization of the world: From edge to core","author":"Reinsel","year":"2018"},{"issue":"3","key":"2021102516595617800_ref2","article-title":"Big data analytics in heathcare: Promise and\n                        potential","volume":"2","author":"Raghupathi","year":"2014","journal-title":"Health Information Science and\n                        Systems"},{"key":"2021102516595617800_ref3","volume-title":"InsideBIGDATA Guide to Healthcare & Life Sciences","year":"2016"},{"key":"2021102516595617800_ref4","doi-asserted-by":"crossref","first-page":"160018","DOI":"10.1038\/sdata.2016.18","article-title":"The FAIR Guiding Principles for scientific data management\n                        and stewardship","volume":"3","author":"Wilkinson","year":"2016","journal-title":"Scientific Data"},{"key":"2021102516595617800_ref5","volume-title":"FAIR Principles","year":"2021"},{"key":"2021102516595617800_ref6","volume-title":"G7 Expert Group on Open Science. Executive Summary","year":"2017"},{"key":"2021102516595617800_ref7","volume-title":"NIH Data Commons Pilot Phase Consortium","year":"2018"},{"key":"2021102516595617800_ref8","volume-title":"Turning fair into reality: Final report and action plan from the\n                        European Commission Expert Group on Fair Data (2018)"},{"key":"2021102516595617800_ref9","volume-title":"Pfizer follows Novartis and GlaxoSmithKline by appointing new Chief\n                        Digital Officer (2018)","author":"Staines"},{"key":"2021102516595617800_ref10","volume-title":"Digital innovation strategy for Roche","year":"2021"},{"issue":"8","key":"2021102516595617800_ref11","doi-asserted-by":"crossref","first-page":"592","DOI":"10.1016\/j.tips.2019.06.004","article-title":"Advancing drug discovery via artificial\n                        intelligence","volume":"40","author":"Chan","year":"2019","journal-title":"Trends in Pharmacological\n                        Sciences"},{"issue":"4","key":"2021102516595617800_ref12","doi-asserted-by":"crossref","first-page":"933","DOI":"10.1016\/j.drudis.2019.01.008","article-title":"Implementation and relevance of FAIR data principles in\n                        biopharmaceutical R&D","volume":"24","author":"Wise","year":"2019","journal-title":"Drug Discovery\n                        Today"},{"key":"2021102516595617800_ref13","volume-title":"The evolution of biomarker use in clinical trials for cancer\n                        treatments","author":"Vadas","year":"2019"},{"key":"2021102516595617800_ref14","doi-asserted-by":"crossref","DOI":"10.1201\/9780429202872","volume-title":"Handbook of\n                        biomarkers and precision medicine","author":"Carini","year":"2019","edition":"1st edition"},{"issue":"1","key":"2021102516595617800_ref15","doi-asserted-by":"crossref","first-page":"61","DOI":"10.4155\/cli.14.106","article-title":"Application of biomarkers in oncology clinical\n                        trials","volume":"5","author":"Dakappagari","year":"2015","journal-title":"Clinical Investigation"},{"key":"2021102516595617800_ref16","volume-title":"Clinical development success rates 2006\u20132015","author":"Thomas","year":"2016"},{"key":"2021102516595617800_ref17","volume-title":"Study data technical\n                        conformance guide","author":"U.S. Food and Drug Administration","year":"2018"},{"key":"2021102516595617800_ref18","article-title":"Preparing legacy format data for submission to the FDA: When\n                        & why must I do it, what format should I follow?","volume-title":"PharmaSug paper","author":"Izard","year":"2016"},{"issue":"91","key":"2021102516595617800_ref19","article-title":"The development and deployment of Common Data Elements for\n                        tissue banks for translational research in cancer \u2013 An emerging\n                        standard based approach for the Mesothelioma Virtual Tissue\n                        Bank","volume":"8","author":"Mohanty","year":"2008","journal-title":"BMC Cancer"},{"issue":"3","key":"2021102516595617800_ref20","doi-asserted-by":"crossref","first-page":"1296","DOI":"10.4103\/jfmpc.jfmpc_931_19","article-title":"Common data elements of breast cancer for research databases:\n                        A systematic review","volume":"9","author":"Mirbagheri","year":"2020","journal-title":"Family Medicine and Primary\n                        Care"},{"key":"2021102516595617800_ref21","doi-asserted-by":"crossref","first-page":"116","DOI":"10.1159\/000502951","article-title":"Metadata concepts for advancing the use of digital\n                        technologies in clinical research","volume":"3","author":"Badawy","year":"2019","journal-title":"Digital\n                        Biomarkers"},{"issue":"10","key":"2021102516595617800_ref22","first-page":"1","article-title":"Tidy data","volume":"59","author":"Wickam","year":"2014","journal-title":"Journal of Statistical\n                        Software"},{"issue":"4","key":"2021102516595617800_ref23","doi-asserted-by":"crossref","first-page":"933","DOI":"10.1016\/j.drudis.2019.01.008","article-title":"Implementation and relevance of FAIR data principles in\n                        biopharmaceutical R&D","volume":"24","author":"Wise","year":"2019","journal-title":"Drug Discovery\n                        Today"},{"key":"2021102516595617800_ref24","doi-asserted-by":"crossref","first-page":"42","DOI":"10.1186\/s13326-017-0151-z","article-title":"PIBAS FedSPARQL: A web-based platform for integration and\n                        exploration of bioinformatics data sets","volume":"8","author":"Djokic-Petrovic","year":"2017","journal-title":"Journal of\n                        Biomedical Semantics"},{"issue":"1","key":"2021102516595617800_ref25","doi-asserted-by":"crossref","first-page":"26","DOI":"10.1186\/2041-1480-4-26","article-title":"The clinical measurement, measurement method and\n                        experimental condition ontologies: Expansion, improvements and new\n                        applications","volume":"4","author":"Smith","year":"2013","journal-title":"Journal of Biomedical\n                        Semantics"},{"issue":"5","key":"2021102516595617800_ref26","doi-asserted-by":"crossref","first-page":"e13484","DOI":"10.2196\/13484","article-title":"Use and understanding of anonymization and de-identification\n                        in the biomedical literature: Scoping review","volume":"21","author":"Chevrier","year":"2019","journal-title":"Journal of Medical Internet Research"},{"issue":"1","key":"2021102516595617800_ref27","doi-asserted-by":"crossref","first-page":"8","DOI":"10.4274\/balkanmedj.2017.0966","article-title":"Patient privacy in the era of big data","volume":"35","author":"Kayaalp","year":"2018","journal-title":"Balkan Medical Journal"},{"key":"2021102516595617800_ref28","first-page":"707","article-title":"Challenges and insights in using HIPAA Privacy Rule for\n                        clinical text annotation","volume-title":"AMIA Annual Symposium\n                        proceedings","author":"Kayaalp","year":"2015"}],"container-title":["Data Intelligence"],"original-title":[],"language":"en","link":[{"URL":"http:\/\/direct.mit.edu\/dint\/article-pdf\/3\/4\/631\/1968567\/dint_a_00106.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"syndication"},{"URL":"http:\/\/direct.mit.edu\/dint\/article-pdf\/3\/4\/631\/1968567\/dint_a_00106.pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,3,14]],"date-time":"2025-03-14T07:41:17Z","timestamp":1741938077000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.sciengine.com\/doi\/10.1162\/dint_a_00106"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2021]]},"references-count":28,"journal-issue":{"issue":"4","published-print":{"date-parts":[[2021,10,25]]}},"URL":"https:\/\/doi.org\/10.1162\/dint_a_00106","relation":{},"ISSN":["2641-435X"],"issn-type":[{"value":"2641-435X","type":"electronic"}],"subject":[],"published-other":{"date-parts":[[2021]]},"published":{"date-parts":[[2021]]}}}