An audit of studies registered retrospectively with the Clinical Trials Registry of India: A one year analysis

Birajdar, Amit Ravindra; Bose, Debdipta; Nishandar, Tushar B; Shende, Anagha A.; Thatte, Urmila M; Gogtay, Nithya J

doi:10.4103/picr.picr_163_17

Cited by 7 publications

(6 citation statements)

References 10 publications

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“…Based on the trials registered, it could be assumed that many trials were registered under the non-communicable disease category before COVID19. It is also in alliance with the WHO-ICTRP [ 17 ]. Siddha system is concentrated in South India, especially in Tamil Nadu [ 18 ].…”

Section: Discussionmentioning

confidence: 99%

Analysis of AYUSH studies registered in clinical trials registry of India from 2009 to 2020

Devi

Sathiyarajeswaran

Kanakavalli

et al. 2021

Journal of Ayurveda and Integrative Medicine

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Background The Clinical Trials Registry—India (CTRI) is an initiative of the Indian Council of Medical Research, New Delhi, India (ICMR) and monitored by the ICMR-National Institute of Medical Statistics (NIMS) since July 20, 2007. Randomized clinical trials are considered as the gold standard in evidence-based medicine. Registration of clinical trials enables disseminating evidence among clinicians, researchers, and patients. It promotes transparency and avoids duplication. The registration process is mandatory for AYUSH clinical trials also. Objectives This analysis is aimed to determine the different characteristics of registered AYUSH clinical trials in CTRI from 2009 to 2020. Materials and methods A cross-sectional retrospective analysis was conducted. The information on registered clinical trials about AYUSH was obtained from the website www.ctri.nic.in from 2009 to 2020 ( n = 3632; last accessed on July 30 2020). Data analysis considered the following factors for analysis using descriptive statistics. The number of clinical trials registered in AYUSH stream were classified according to registration type (retrospective/prospective), postgraduate dissertations (yes/no), primary sponsor, type of trial (interventional/observational), study design, health condition and State-wise distribution of sites of studies. Results The number of clinical trial registrations among AYUSH streams (3632) descends from Ayurveda (2054), followed by Siddha (635), Yoga (408), Unani (366) and Homoeopathy (169). Interventional studies dominate observational studies among all AYUSH registered trials. AYUSH streams took four years to register in CTRI due to an increase in reporting trials from 2013. Significant number of trials were registered retrospectively. The order of closure of retrospective registration has influenced an increase in prospective enrolment between 2017–2019. Conclusion Registration of clinical trials in the CTRI should be encouraged. Randomized controlled trials (RCTs) occupy a rear seat which exposes an opportunity for trials and alarms about weak trials. Non-communicable diseases (NCDs) are registered more comparatively, which reflects the strength of AYUSH in NCDs. Most of the trials fall under phase 2, which seems to have an increasing opportunity for more trials. Certain visible flaws like registering Phase 2 trials as Phase 3 or 4 and domestic trials as international trials reflect human resources crunch in ICMR-CTRI in Issuing Certificates. These errors should be rectified by training the stakeholders effectively.

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Section: Discussionmentioning

confidence: 99%

Analysis of AYUSH studies registered in clinical trials registry of India from 2009 to 2020

Devi

Sathiyarajeswaran

Kanakavalli

et al. 2021

Journal of Ayurveda and Integrative Medicine

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“…While prospective registration has increased over the past decade, retrospective registration is still widespread. [10][11][12][13][14] Some registries, such as Deutsches Register Klinischer Studien (DRKS) or the WHO's International Clinical Trials Registry Platform, explicitly mark retrospectively registered entries as such, whereas others, such as Clin-icalTrials. gov, do not.…”

Section: Strengths and Limitations Of This Studymentioning

confidence: 99%

“…When trials are registered retrospectively, that is, their registry entry is created after study start, this undermines many of the reasons for registration. While prospective registration has increased over the past decade, retrospective registration is still widespread 10–14. Some registries, such as Deutsches Register Klinischer Studien (DRKS) or the WHO’s International Clinical Trials Registry Platform, explicitly mark retrospectively registered entries as such, whereas others, such as ClinicalTrials.gov, do not.…”

Section: Introductionmentioning

confidence: 99%

Reporting of retrospective registration in clinical trial publications: a cross-sectional study of German trials

2023

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ObjectiveProspective registration has been widely implemented and accepted as a best practice in clinical research, but retrospective registration is still commonly found. We assessed to what extent retrospective registration is reported transparently in journal publications and investigated factors associated with transparent reporting.DesignWe used a dataset of trials registered in ClinicalTrials.gov or Deutsches Register Klinischer Studien, with a German University Medical Center as the lead centre, completed in 2009–2017, and with a corresponding peer-reviewed results publication. We extracted all registration statements from results publications of retrospectively registered trials and assessed whether they mention or justify the retrospective registration. We analysed associations of retrospective registration and reporting thereof with registration number reporting, International Committee of Medical Journal Editors (ICMJE) membership/-following and industry sponsorship using χ2or Fisher exact test.ResultsIn the dataset of 1927 trials with a corresponding results publication, 956 (53.7%) were retrospectively registered. Of those, 2.2% (21) explicitly report the retrospective registration in the abstract and 3.5% (33) in the full text. In 2.1% (20) of publications, authors provide an explanation for the retrospective registration in the full text. Registration numbers were significantly underreported in abstracts of retrospectively registered trials compared with prospectively registered trials. Publications in ICMJE member journals did not have statistically significantly higher rates of both prospective registration and disclosure of retrospective registration, and publications in journals claiming to follow ICMJE recommendations showed statistically significantly lower rates compared with non-ICMJE-following journals. Industry sponsorship of trials was significantly associated with higher rates of prospective registration, but not with transparent registration reporting.ConclusionsContrary to ICMJE guidance, retrospective registration is disclosed and explained only in a small number of retrospectively registered studies. Disclosure of the retrospective nature of the registration would require a brief statement in the manuscript and could be easily implemented by journals.

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“…While studies funded by the pharmaceutical industry were four times more likely to be prospectively registered (relative to studies not funded by the pharmaceutical industry), postgraduate theses were twice as likely to be retrospectively registered relative to other studies. [ 3 ]…”

Section: Introductionmentioning

confidence: 99%

Has mandatory prospective registration of all studies brought about a change? A 1-year audit of studies registered in the Clinical Trials Registry of India [CTRI] before and after April 1, 2018

Shetty

Salvi

Thatte

et al. 2021

Perspectives in Clinical Research

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Introduction: The Clinical Trials Registry of India (CTRI) that initially permitted retrospective registration moved to mandatory prospective registration of studies with effect from April 1, 2018. The present study was an audit that compared registration 1 year post the rule versus a year prior to it. Materials and Methods: All studies registered with the CTRI from April 1, 2017, to March 31, 2018, and subsequently from April 1, 2018, to March 31, 2019, were included for the analysis. The extents of retrospective registration a year pre and a year post April 1, 2018, of all studies were evaluated. Results: A total of 4628 studies were registered prior to April 1, 2018, and 5438 post that. Pre April 1, 2018, 2687 / 4628 (58.06%) studies were retrospectively registered, while post that, 1100 / 5438 (20.23%) studies were retrospectively registered (cOR: 5.46 [5.0, 5.9], P < 0.001). Regardless of whether the studies were PG theses, regulatory studies, observational studies, or interventional studies, there was a statistically significant reduction in the number retrospectively registered post April 1, 2018, relative to the year predating it. Discussion and Conclusion: The success of CTRI's decision to move to prospective registration is seen in the overall reduction in the total number of retrospective registrations from nearly two-thirds in the year predating April 1, 2018, to just a quarter in the year post that, indicating significant inroads made by the CTRI with regard to raising awareness. Some regulatory studies continue to be retrospectively registered and this presents a significant ethical and regulatory breach. This could be potentially addressed by linking ethics committee approval with trial registration.

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An audit of studies registered retrospectively with the Clinical Trials Registry of India: A one year analysis

Cited by 7 publications

References 10 publications

Analysis of AYUSH studies registered in clinical trials registry of India from 2009 to 2020

Analysis of AYUSH studies registered in clinical trials registry of India from 2009 to 2020

Reporting of retrospective registration in clinical trial publications: a cross-sectional study of German trials

Has mandatory prospective registration of all studies brought about a change? A 1-year audit of studies registered in the Clinical Trials Registry of India [CTRI] before and after April 1, 2018

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