Institute of Bioinformatics and Applied Biotechnology, Biotech Park, Bengaluru 560 100 INDIA.
Indian J Med Ethics. 2022 Oct-Dec;VII(4):312-314. doi: 10.20529/IJME.2022.033. Epub 2022 May 13.
In a clinical trial registry, one determines whether a trial is registered prospectively or retrospectively by comparing the date of registration with the date on which enrollment started. However, in Clinical Trials Registry - India (CTRI), in addition, the top of each record is labelled with the phrase "Trial Registered Prospectively" or "Trial Registered Retrospectively". In examining CTRI records, we have found that (a) although retrospective registration has been disallowed from April 1, 2018, some trials were registered retrospectively; (b) in some cases, enrollment started after registration, even though they were labelled "Trial Registered Retrospectively", which is misleading; and (c) in some cases, the date of first enrollment was modified, changing a retrospective registration to a prospective one, although the label "Trial Registered Retrospectively" persisted. This, too, is misleading. The CTRI administration should take suitable steps to prevent late registration and mislabelling of trials regarding their registration status.
在临床试验注册中心，可以通过比较注册日期和入组日期来确定试验是前瞻性注册还是回顾性注册。然而，在印度临床试验注册中心（CTRI），每条记录的顶部还标有“前瞻性注册试验”或“回顾性注册试验”的字样。在检查 CTRI 记录时，我们发现：（a）尽管自 2018 年 4 月 1 日起已禁止回顾性注册，但仍有一些试验是回顾性注册的；（b）在某些情况下，尽管被标记为“回顾性注册试验”，但入组是在注册之后进行的，这具有误导性；（c）在某些情况下，首次入组日期被修改，将回顾性注册改为前瞻性注册，但“回顾性注册试验”的标签仍然存在。这也具有误导性。CTRI 管理部门应采取适当措施，防止试验延迟注册和注册状态的错误标记。
