UpdateBot at 15:45, 24 March 2022

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{{Short description|India's clinical trial registry}}
'''Clinical Trials Registry – India''' ('''CTRI''') is the government of India's official [[Clinical trial registration|clinical trial registry]]. The National Institute of Medical Statistics of the [[Indian Council of Medical Research]] established the CTRI on 20 July 2007.<ref name="Rao 2018"/> Since 2009 the [[Central Drugs Standard Control Organization]] has mandated that anyone conducting [[clinical trials in India]] must [[preregister]] before enrolling any [[research participants]].<ref name="Rao 2018">{{cite journal |last1=Rao |first1=M. Vishnu Vardhana |last2=Maulik |first2=Mohua |last3=Gupta |first3=Jyotsna |last4=Panchal |first4=Yashmin |last5=Juneja |first5=Atul |last6=Adhikari |first6=Tulsi |last7=Pandey |first7=Arvind |title=Clinical Trials Registry – India: An overview and new developments |journal=Indian Journal of Pharmacology |date=1 July 2018 |volume=50 |issue=4 |pages=208–211 |doi=10.4103/ijp.IJP_153_18 |pmid=30505058 |language=en |issn=0253-7613|pmc=6234713 }}</ref>

==History==
In 2004 the International Committee of Medical Journal Editors published the [[ICMJE recommendations]], which advocated that medical journals only publish clinical research if the researchers have registered it.<ref>{{cite journal |last1=De Angelis |first1=Catherine |last2=Drazen |first2=Jeffrey M. |last3=Frizelle |first3=Frank A. |last4=Haug |first4=Charlotte |last5=Hoey |first5=John |last6=Horton |first6=Richard |last7=Kotzin |first7=Sheldon |last8=Laine |first8=Christine |last9=Marusic |first9=Ana |last10=Overbeke |first10=A. John P.M. |last11=Schroeder |first11=Torben V. |last12=Sox |first12=Hal C. |last13=Weyden |first13=Martin B. Van Der |title=Clinical Trial Registration: A Statement from the International Committee of Medical Journal Editors |journal=New England Journal of Medicine |date=16 September 2004 |volume=351 |issue=12 |pages=1250–1251 |doi=10.1056/NEJMe048225|pmid=15356289 }}</ref> This statement had global influence and started conversations about clinical trial registration in India.<ref>{{cite journal |last1=Tharyan |first1=P |title=Ethics committees and clinical trials registration in India: opportunities, obligations, challenges and solutions. |journal=[[Indian Journal of Medical Ethics]] |date=2007 |volume=4 |issue=4 |pages=168–9 |doi=10.20529/IJME.2007.066 |pmid=18630235}}</ref><ref name="Rao 2018"/>

The [[Indian Council of Medical Research]] established the CTRI on 20 July 2007.<ref name="Rao 2018">{{cite journal |last1=Rao |first1=M. Vishnu Vardhana |last2=Maulik |first2=Mohua |last3=Gupta |first3=Jyotsna |last4=Panchal |first4=Yashmin |last5=Juneja |first5=Atul |last6=Adhikari |first6=Tulsi |last7=Pandey |first7=Arvind |title=Clinical Trials Registry – India: An overview and new developments |journal=Indian Journal of Pharmacology |date=1 July 2018 |volume=50 |issue=4 |pages=208–211 |doi=10.4103/ijp.IJP_153_18 |pmid=30505058 |language=en |issn=0253-7613|pmc=6234713 }}</ref> By the end of 2007 the registry indexed 31 trials.{{cn|date=April 2021}} 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.<ref>{{cite journal |last1=Satyanarayana |first1=K |last2=Sharma |first2=A |last3=Parikh |first3=P |last4=Vijayan |first4=VK |last5=Sahu |first5=DK |last6=Nayak |first6=BK |last7=Gulati |first7=RK |last8=Parikh |first8=MN |last9=Singh |first9=PP |last10=Bavdekar |first10=SB |last11=Sreehari |first11=U |last12=Sahni |first12=P |title=Statement on publishing clinical trials in Indian biomedical journals. |journal=The Indian Journal of Medical Research |date=February 2008 |volume=127 |issue=2 |pages=104–5 |pmid=18403785}}</ref>

The [[Central Drugs Standard Control Organisation]] made trial registration mandatory on 15 June 2009.<ref name="Sarangi 2011">{{cite journal |last1=Sarangi |first1=SC |last2=Medhi |first2=B |title=Clinical trials in India: issues with adherence to CONSORT statements. |journal=Journal of Clinical Epidemiology |date=August 2011 |volume=64 |issue=8 |pages=925–6 |doi=10.1016/j.jclinepi.2011.03.002 |pmid=21704256}}</ref> The rule was that researchers must [[preregister]] trials before the enrollment of any research participants.<ref name="Sarangi 2011"/> In April 2018 the CTRI reiterated this rule, saying that there had been a practice of starting clinical trials and enrolling patients without registering the trial.<ref>{{cite web |last1=Kaul |first1=Rhythma |title=Mandatory to register clinical trials before tests begin |url=https://www.hindustantimes.com/india-news/mandatory-to-register-clinical-trials-before-tests-begin/story-3GAsFkEw7TA9bL70nkxvjM.html |website=Hindustan Times |language=en |date=25 October 2017}}</ref> There had been past calls for preregistration.<ref>{{cite journal |last1=Tharyan |first1=P |title=Prospective registration of clinical trials in India: strategies, achievements & challenges. |journal=Journal of Evidence-Based Medicine |date=February 2009 |volume=2 |issue=1 |pages=19–28 |doi=10.1111/j.1756-5391.2009.01015.x |pmid=21348978}}</ref>

==Data collected==
The CTRI requests all the information which the World Health Organization recommends for clinical trial registries.<ref name="WHO 2008">{{cite journal |title=Clinical trials in India: ethical concerns. |journal=Bulletin of the World Health Organization |date=August 2008 |volume=86 |issue=8 |pages=581–2 |doi=10.2471/blt.08.010808 |pmid=18797610|last1=Chatterjee |first1=Patralekha |pmc=2649459 }}</ref> Additionally, the CTRI collects information specific to the circumstances of India, including the address of the [[principal investigator]], the name of the ethics committee overseeing the trial and confirmation of their government registration; proof of permission from the [[Drugs Controller General of India]], the expected end date of the trial; all study sites; and the method of randomizing participants and the [[allocation concealment]].<ref name="WHO 2008"/> The World Health Organization Registry for clinical trials helped make the Indian registry more effective.<ref>{{cite journal |last1=Tharyan |first1=P |title=The WHO International Clinical Trials Registry Platform: relevance to the Indian register of clinical trials. |journal=The National Medical Journal of India |date=2006 |volume=19 |issue=3 |pages=161–4 |pmid=16836269}}</ref>

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.<ref>{{cite journal |last1=Sil |first1=Amrita |last2=Das |first2=NilayKanti |title=How to register a clinical trial in India? |journal=Indian Journal of Dermatology |date=2013 |volume=58 |issue=3 |pages=235–6 |doi=10.4103/0019-5154.110836|pmid=23723478 |pmc=3667290 |doi-access=free }}</ref>

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.<ref name="Pillamarapu 2019">{{cite journal |last1=Pillamarapu |first1=Mounika |last2=Mohan |first2=Abhilash |last3=Saberwal |first3=Gayatri |title=An analysis of deficiencies in the data of interventional drug trials registered with Clinical Trials Registry - India |journal=Trials |date=28 August 2019 |volume=20 |issue=1 |page=535 |doi=10.1186/s13063-019-3592-0|pmid=31455366 |pmc=6712861 |doi-access=free }}</ref> One factor which introduced error into the registry include that users register their own trials, sometimes with misunderstanding or errors in their submissions.<ref name="Pillamarapu 2019"/> 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.<ref name="Pillamarapu 2019"/>

==Research==
A 2018 paper expressed that the CTRI had the benefit of preventing selective reporting of results and duplication of research.<ref name="Bhaskar 2018">{{cite journal |last1=Bhaskar |first1=S. Bala |title=Clinical trial registration: A practical perspective |journal=Indian Journal of Anaesthesia |date=1 January 2018 |volume=62 |issue=1 |pages=10–15 |doi=10.4103/ija.IJA_761_17 |pmid=29416145 |pmc=5787884 |language=en |issn=0019-5049|doi-access=free }}</ref> It also empowered patients and the public and informed ethics committees to and researchers about current and past trials.<ref name="Bhaskar 2018"/>

==References==
{{reflist}}

==External links==
{{Scholia|Q96122962}}
*{{official website|http://ctri.nic.in}}

{{DEFAULTSORT:Clinical Trials Registry - India}}
[[Category:Clinical trials]]
[[Category:Government services web portals in India]]

Clinical Trials Registry India - Revision history

UpdateBot at 15:45, 24 March 2022