757:
155:
A 2018 paper expressed that the CTRI had the benefit of preventing selective reporting of results and duplication of research. It also empowered patients and the public and informed ethics committees to and researchers about current and past trials. A 2022 audit of data fields in clinical registries
118:
made trial registration mandatory on 15 June 2009. The rule was that researchers must pre-register trials before the enrollment of any research participants. In April 2018 the CTRI reiterated this rule, saying that there had been a practice of starting clinical trials and enrolling patients without
146:
A 2019 evaluation reported that the registry improves the national quality of clinical trials in India but also that the registry itself would benefit from development to ensure more accurate data. One factor which introduced errors into the registry include that users register their own trials,
239:
De
Angelis, Catherine; Drazen, Jeffrey M.; Frizelle, Frank A.; Haug, Charlotte; Hoey, John; Horton, Richard; Kotzin, Sheldon; Laine, Christine; Marusic, Ana; Overbeke, A. John P.M.; Schroeder, Torben V.; Sox, Hal C.; Weyden, Martin B. Van Der (16 September 2004).
147:
sometimes with misunderstanding or errors in their submissions. Another factor is that the registration form itself lacks the precision which researchers would typically want, and for example, the "type of study" field is recording unclear responses.
110:
established the CTRI on 20 July 2007. By the end of 2007 the registry indexed 31 trials. In
February 2008 various editors of medical journals in India pledged to avoid publishing articles about any clinical trial in India which was not registered.
324:
Satyanarayana, K; Sharma, A; Parikh, P; Vijayan, VK; Sahu, DK; Nayak, BK; Gulati, RK; Parikh, MN; Singh, PP; Bavdekar, SB; Sreehari, U; Sahni, P (February 2008). "Statement on publishing clinical trials in Indian biomedical journals".
127:
The CTRI requests all the information which the World Health
Organization recommends for clinical trial registries. Additionally, the CTRI collects information specific to the circumstances of India, including the address of the
103:, which advocated that medical journals only publish clinical research if the researchers have registered it. This statement had global influence and started conversations about clinical trial registration in India.
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A review of the registry recommended that researchers who are wondering whether to register their research should resolve their concern by attempting to register in CTRI.
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391:
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found CTRI was one of the few clinical trial registries whose data fields pertaining to individual participant data availability was compliant with ICMJE guidelines.
29:
693:
814:
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694:"Compliance with International Committee of Medical Journal Editors policy on individual participant data sharing in clinical trial registries: An audit"
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132:, the name of the ethics committee overseeing the trial and confirmation of their government registration; proof of permission from the
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Rao, M. Vishnu
Vardhana; Maulik, Mohua; Gupta, Jyotsna; Panchal, Yashmin; Juneja, Atul; Adhikari, Tulsi; Pandey, Arvind (1 July 2018).
107:
72:
133:
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Tharyan, P (2006). "The WHO International
Clinical Trials Registry Platform: relevance to the Indian register of clinical trials".
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409:
Tharyan, P (February 2009). "Prospective registration of clinical trials in India: strategies, achievements & challenges".
581:"An analysis of deficiencies in the data of interventional drug trials registered with Clinical Trials Registry - India"
68:
283:"Ethics committees and clinical trials registration in India: opportunities, obligations, challenges and solutions"
804:
80:
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Sarangi, SC; Medhi, B (August 2011). "Clinical trials in India: issues with adherence to CONSORT statements".
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140:. The World Health Organization Registry for clinical trials helped make the Indian registry more effective.
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136:, the expected end date of the trial; all study sites; and the method of randomising participants and the
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242:"Clinical Trial Registration: A Statement from the International Committee of Medical Journal Editors"
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In 2004 the
International Committee of Medical Journal Editors published the
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Pillamarapu, Mounika; Mohan, Abhilash; Saberwal, Gayatri (28 August 2019).
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registering the trial. There had been past calls for preregistration.
182:"Clinical Trials Registry – India: An overview and new developments"
392:"Mandatory to register clinical trials before tests begin"
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635:"Clinical trial registration: A practical perspective"
71:. The National Institute of Medical Statistics of the
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established the CTRI on 20 July 2007. Since 2009 the
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692:Borana, Ronak; Bhaumik, Soumyadeep (2022-10-01).
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44:ICMR's National Institute of Medical Statistics
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525:"How to register a clinical trial in India?"
449:"Clinical trials in India: ethical concerns"
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116:Central Drugs Standard Control Organisation
77:Central Drugs Standard Control Organisation
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810:Government services web portals in India
67:) is the government of India's official
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447:Chatterjee, Patralekha (August 2008).
327:The Indian Journal of Medical Research
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523:Sil, Amrita; Das, NilayKanti (2013).
498:The National Medical Journal of India
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79:has mandated that anyone conducting
633:Bhaskar, S. Bala (1 January 2018).
815:Indian Council of Medical Research
411:Journal of Evidence-Based Medicine
108:Indian Council of Medical Research
73:Indian Council of Medical Research
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768:Clinical Trials Registry – India
698:Perspectives in Clinical Research
390:Kaul, Rhythma (25 October 2017).
134:Drugs Controller General of India
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423:10.1111/j.1756-5391.2009.01015.x
357:Journal of Clinical Epidemiology
288:Indian Journal of Medical Ethics
61:Clinical Trials Registry – India
22:Clinical Trials Registry – India
246:New England Journal of Medicine
18:India's clinical trial registry
369:10.1016/j.jclinepi.2011.03.002
186:Indian Journal of Pharmacology
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639:Indian Journal of Anaesthesia
529:Indian Journal of Dermatology
800:2007 establishments in India
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598:10.1186/s13063-019-3592-0
26:
542:10.4103/0019-5154.110836
81:clinical trials in India
711:10.4103/picr.picr_85_22
69:clinical trial registry
652:10.4103/ija.IJA_761_17
302:10.20529/IJME.2007.066
199:10.4103/ijp.IJP_153_18
138:allocation concealment
130:principal investigator
465:10.2471/blt.08.010808
101:ICMJE recommendations
89:research participants
87:before enrolling any
53:https://ctri.nic.in/
281:Tharyan, P (2007).
259:10.1056/NEJMe048225
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765:has a profile for
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252:(12): 1250–1251.
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85:preregister
794:Categories
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160:References
720:2229-3485
661:0019-5049
208:0253-7613
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679:29416145
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268:15356289
226:30505058
151:Research
763:Scholia
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114:The
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65:CTRI
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