Institute of Bioinformatics and Applied Biotechnology, Biotech Park, Electronics City Phase 1, Bengaluru, Karnataka, 560100, India.
Trials. 2019 Aug 28;20(1):535. doi: 10.1186/s13063-019-3592-0.
Clinical Trials Registry - India (CTRI) was established in July 2007 and today hosts thousands of trials, a significant fraction of them registered in the last couple of years. We wished to undertake an up-to-date analysis of specific fields of the registered trials. In doing so we discovered problems with the quality of the data, which we describe in this paper.
We downloaded CTRI records and reformatted the data into an SQLite database, which we then queried. We also accessed ClinicalTrials.gov records as needed.
We discovered various categories of problems with the data in the CTRI database, including (1) a lack of clarity in the classification of Types of Study, (2) internal inconsistencies, (3) incomplete or non-standard information, (4) missing data, (5) variations in names or classification, and (6) incomplete or incorrect details of ethics committees. For most of these problems, error rates have been calculated, over time. Most were found to be in single digits, although others were significantly higher. We suggest how data quality in future editions of CTRI could be improved, including (1) a more elaborate and structured way of classifying the Type of Study, (2) the use of logic rules to prevent internal inconsistencies, (3) less use of free text fields and greater use of drop-down menus, (4) more fields to be made compulsory, (5) the pre-registration of individuals' and organizations' names and their subsequent selection from drop-down menus while registering a trial, and (6) more information about each ethics committee, including (a) its address and (b) linking the name of the trial site to the relevant ethics committee. As we discuss problems with the data of specific fields, we also examine - where possible - the quality of the data in the corresponding fields in ClinicalTrials.gov, the largest clinical trial registry in the world.
It is a scientific and ethical obligation to correctly record all information pertaining to each trial run in India. CTRI is a valuable database that has proved its worth in terms of improving the record of trials in the country. The suggestions made herein would improve it further.
临床试验注册印度（CTRI）于 2007 年 7 月成立，目前拥有数千项试验，其中很大一部分是在过去几年注册的。我们希望对已注册试验的特定领域进行最新分析。在这样做的过程中，我们发现了数据质量存在问题，本文对此进行了描述。
我们下载了 CTRI 记录，并将数据重新格式化为 SQLite 数据库，然后对其进行查询。我们还根据需要访问了 ClinicalTrials.gov 记录。
我们发现 CTRI 数据库中的数据存在各种类别问题，包括（1）研究类型分类不明确，（2）内部不一致，（3）信息不完整或不标准，（4）数据缺失，（5）名称或分类变化，（6）伦理委员会的不完整或不正确细节。对于大多数这些问题，已经计算了随时间变化的错误率。虽然有些错误率较高，但大多数错误率都在个位数。我们提出了如何在 CTRI 的未来版本中提高数据质量的建议，包括（1）更精细和结构化的研究类型分类方式，（2）使用逻辑规则防止内部不一致，（3）减少使用自由文本字段，更多地使用下拉菜单，（4）更多字段设为必填项，（5）在注册试验时，预先注册个人和组织的名称，并从下拉菜单中选择，（6）提供更多关于每个伦理委员会的信息，包括（a）其地址和（b）将试验地点的名称与相关伦理委员会联系起来。在讨论特定字段数据的问题时，我们还检查了世界上最大的临床试验注册处 ClinicalTrials.gov 中相应字段的数据质量（如果可能的话）。
正确记录在印度进行的每项试验的所有相关信息是一项科学和伦理义务。CTRI 是一个有价值的数据库，它已经证明了在提高该国试验记录方面的价值。本文提出的建议将进一步提高其价值。
