Department of Clinical Pharmacology, Zenica Cantonal Hospital, Zenica, Bosnia and Herzegovina.
Faculty of Medicine, University of Zenica, Zenica, Bosnia and Herzegovina.
Biochem Med (Zagreb). 2018 Feb 15;28(1):010201. doi: 10.11613/BM.2018.010201.
The aim of the IMPACT (IMProving Access to Clinical Trial data) Observatory is to assess the transformation of clinical trials (CT) related to the evolution of sharing of CT data. The objective of this study is to establish a baseline for monitoring CT data sharing by the Observatory.
In this scoping review we searched for publications that address sharing, dissemination, transparency or reuse of CT data published prior to December 31st 2000. Two authors screened titles and abstracts of 1204 records received by Medline searches and added 47 publications from direct discovery. Four researchers extracted, coded, and analyzed the predefined information from 102 selected papers.
We found a growing recognition of the importance of data sharing prior to 2001. However, there were numerous obstacles including the ambiguity of the concept of data sharing, the absence of specific terminology and the lack of an "open" culture. By the end of 2000, data, metadata, and evidence based medicine were defined. Data sharing, registries, databases and re-analyses of individual patient data (IPD) emerged. The use of systematic reviews and IPD meta-analysis in decision making was promoted. Most arguments for broader data sharing came from oncology, paediatrics, rare diseases, AIDS, pregnancy, perinatal medicine, and media reporting related scandals.
Our findings indicate that the year 2000 could be used as a baseline for monitoring the evolution of CT data sharing as basic prerequisites were set in place, including greater understanding that CT data sharing is essential for decision making and the advancements of the Internet.
IMPACT（改善临床试验数据获取）观测站的目的是评估与临床试验数据共享演变相关的临床试验（CT）变革。本研究的目的是为观测站监测 CT 数据共享建立一个基线。
在这项范围性综述中，我们搜索了发表于 2000 年 12 月 31 日之前的关于 CT 数据共享、传播、透明度或再利用的出版物。两名作者筛选了 Medline 搜索收到的 1204 条记录的标题和摘要，并从直接发现中添加了 47 篇出版物。四名研究人员从 102 篇选定的论文中提取、编码和分析了预设信息。
我们发现，在 2001 年之前，人们越来越认识到数据共享的重要性。然而，存在许多障碍，包括数据共享概念的模糊性、缺乏特定术语以及缺乏“开放”文化。到 2000 年底，数据、元数据和循证医学已经得到定义。数据共享、注册处、数据库和个体患者数据（IPD）的重新分析已经出现。促进了在决策中使用系统评价和 IPD 荟萃分析。更广泛的数据共享的大多数论点来自肿瘤学、儿科学、罕见疾病、艾滋病、妊娠、围产期医学以及与媒体报道相关的丑闻。
我们的研究结果表明，2000 年可以用作监测 CT 数据共享演变的基线，因为已经建立了基本的前提条件，包括更深入地理解 CT 数据共享对于决策制定的重要性以及互联网的进步。
