CTRI requirement of prospective trial registration: Not always consistent
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Date
2022-12
Authors
Journal Title
Journal ISSN
Volume Title
Publisher
FORUM FOR MEDICAL ETHICS SOCIETY
Abstract
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.
Description
Keywords
Clinical Trials Registry – India, ethics, data integrity
Citation
Chakraborty I, Saberwal G. CTRI requirement of prospective trial registration: Not always consistent. Indian Journal of Medical Ethics. 2022 Dec; 7(4): 312-314