Goldacre Ben, Gray Jonathan
Centre for Evidence Based Medicine, Department of Primary Care Health Sciences, University of Oxford, Oxford, OX2 6GG, UK.
Department of Non-Communicable Disease Epidemiology, London School of Hygiene and Tropical Medicine, Keppel Street, London, WC1E 7HT, UK.
Trials. 2016 Apr 8;17:164. doi: 10.1186/s13063-016-1290-8.
OpenTrials is a collaborative and open database for all available structured data and documents on all clinical trials, threaded together by individual trial. With a versatile and expandable data schema, it is initially designed to host and match the following documents and data for each trial: registry entries; links, abstracts, or texts of academic journal papers; portions of regulatory documents describing individual trials; structured data on methods and results extracted by systematic reviewers or other researchers; clinical study reports; and additional documents such as blank consent forms, blank case report forms, and protocols. The intention is to create an open, freely re-usable index of all such information and to increase discoverability, facilitate research, identify inconsistent data, enable audits on the availability and completeness of this information, support advocacy for better data and drive up standards around open data in evidence-based medicine. The project has phase I funding. This will allow us to create a practical data schema and populate the database initially through web-scraping, basic record linkage techniques, crowd-sourced curation around selected drug areas, and import of existing sources of structured and documents. It will also allow us to create user-friendly web interfaces onto the data and conduct user engagement workshops to optimise the database and interface designs. Where other projects have set out to manually and perfectly curate a narrow range of information on a smaller number of trials, we aim to use a broader range of techniques and attempt to match a very large quantity of information on all trials. We are currently seeking feedback and additional sources of structured data.
OpenTrials是一个协作式开放数据库，收录所有临床试验的结构化数据和文档，并按单个试验进行关联。它具有通用且可扩展的数据模式，最初旨在为每个试验存储和匹配以下文档及数据：注册条目；学术期刊论文的链接、摘要或文本；描述单个试验的监管文档部分；系统评价员或其他研究人员提取的关于方法和结果的结构化数据；临床研究报告；以及其他文档，如空白知情同意书、空白病例报告表和方案。目的是创建一个开放、可自由重用的所有此类信息索引，提高可发现性，促进研究，识别不一致的数据，对这些信息的可用性和完整性进行审核，支持更好数据的宣传，并提高循证医学中开放数据的标准。该项目已获得第一阶段资金。这将使我们能够创建一个实用的数据模式，并最初通过网络抓取、基本记录链接技术、围绕选定药物领域的众包整理以及导入现有结构化数据和文档来源来填充数据库。它还将使我们能够创建用户友好的数据网络界面，并举办用户参与研讨会以优化数据库和界面设计。其他项目已着手手动且完美地整理少量试验的有限信息范围，而我们旨在使用更广泛的技术，并尝试匹配所有试验的大量信息。我们目前正在寻求反馈和其他结构化数据来源。
