Exploring the Current Practices, Costs and Benefits of FAIR Implementation in Pharmaceutical Research and Development: A Qualitative Interview Study
Exploring the Current Practices, Costs and Benefits of FAIR Implementation in Pharmaceutical Research and Development: A Qualitative Interview Study
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DOI：
10.1162/dint_a_00109
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发表时间：
2021-10-25
影响因子：
3.9
通讯作者：
Goble, Carole
中科院分区：
文献类型：
--
作者：
Alharbi, Ebtisam;Skeva, Rigina;Goble, Carole
科学数据管理和管理的可查找、可访问、可互操作、可重用（FAIR）原则旨在促进人类和机器的大规模数据重用。制药行业的研发（R&D）正变得越来越受数据驱动，但根据FAIR原则管理其数据资产仍然成本高昂且具有挑战性。到目前为止，很少有科学证据表明FAIR目前在实践中是如何实施的，其相关的成本和效益是什么，以及如何决定在制药研发中对数据集进行回顾性FAIR化。本文报道了半结构化访谈的结果，14名制药专业人士谁参与了药物研发的各个阶段，在7个制药企业。归纳性专题分析确定了公平信息检索的好处和成本的三个主要专题，以及影响公平信息检索遗留数据集决策过程的因素。与会者共同承认FAIRification对不同研究领域数据可重用性的潜在贡献以及随后节省成本的潜力。然而，与会者仍然认为执行费用是一个障碍，因为需要在资源和文化变革方面进行大量支出。如何做出关于公平化的决定受到法律的和道德考虑、管理承诺和数据优先级的影响。这些发现对于那些从事推动FAIR实施的制药研发行业以及寻求更好地了解现有实践和挑战的外部各方具有重要意义。
The findable, accessible, interoperable, reusable (FAIR) principles for scientific data management and stewardship aim to facilitate data reuse at scale by both humans and machines. Research and development (R&D) in the pharmaceutical industry is becoming increasingly data driven, but managing its data assets according to FAIR principles remains costly and challenging. To date, little scientific evidence exists about how FAIR is currently implemented in practice, what its associated costs and benefits are, and how decisions are made about the retrospective FAIRification of data sets in pharmaceutical R&D. This paper reports the results of semi-structured interviews with 14 pharmaceutical professionals who participate in various stages of drug R&D in seven pharmaceutical businesses. Inductive thematic analysis identified three primary themes of the benefits and costs of FAIRification, and the elements that influence the decision-making process for FAIRifying legacy data sets. Participants collectively acknowledged the potential contribution of FAIRification to data reusability in diverse research domains and the subsequent potential for cost-savings. Implementation costs, however, were still considered a barrier by participants, with the need for considerable expenditure in terms of resources, and cultural change. How decisions were made about FAIRification was influenced by legal and ethical considerations, management commitment, and data prioritisation. The findings have significant implications for those in the pharmaceutical R&D industry who are engaged in driving FAIR implementation, and for external parties who seek to better understand existing practices and challenges.