ArticlePloS one2020
Hidden duplicates: 10s or 100s of Indian trials, registered with ClinicalTrials.gov, have not been registered in India, as required by law.
Article in PloS one, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 9 papers.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
9 citing papers in PubMed.
- Observational
- Identifying trials run in India that are registered in other clinical trial registries: a cross-sectional study.BMC medical research methodology · 2024Article
- Landscape of cancer clinical trials in India - a comprehensive analysis of the Clinical Trial Registry-India.The Lancet regional health. Southeast Asia · 2024Article
- Three levels of discrepancies in the records of trial sites in India, registered with the European Union Clinical Trials Register.Frontiers in medicine · 2024Article
- Data from the Indian drug regulator and from Clinical Trials Registry-India does not always match.Frontiers in medicine · 2024Article
- Article
- The international clinical trials registry platform (ICTRP): data integrity and the trends in clinical trials, diseases, and drugs.Frontiers in pharmacology · 2023Article
- Discrepancies between FDA documents and ClinicalTrials.gov for Orphan Drug-related clinical trial data.PLOS global public health · 2022Article
- A comparative analysis of important public clinical trial registries, and a proposal for an interim ideal one.PloS one · 2021Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
3 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundThis study's primary goal was based on the fact that since 15 June 2009 it has been mandatory to register regulatory trials running in India with Clinical Trials Registry-India (CTRI). Were all such trials, registered with ClinicalTrials.gov (CTG) after 2009, that included India as a location, also registered with CTRI? We first had to determine how to correctly identify a trial that was registered in both the registries, but that lacked the relevant secondary ID. Therefore the secondary goal of this study was to identify the best method to do this.
methodsWe used a control set of 1013 trials that cross-referenced a record in the other registry. We used two algorithms to-in a blinded fashion-identify CTRI matches for the 1013 CTG records. 80% of the predictions were correct. Using the same methodology, we identified matches for the CTG trials without known CTRI matches. We then used a logistic regression model to predict which of these matches were correct.
results(i) 3664 CTG records listed India as a location, but did not list any CTRI ID, and were not identified by any CTRI records either. (ii) The best single field to find a CTRI match for a CTG trial was the title field. (iii) Between 50 and 300 of 581 relevant CTG trials were not registered with CTRI.
conclusionsThis is the first study to use hidden duplicates to determine that the law on trial registration has been broken (in India). Similar studies need to be done for trials run in other countries.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.