Clinical Trials Registry – India

Clinical Trials Registry – India (CTRI) is the government of India's official clinical trial registry. The National Institute of Medical Statistics of the Indian Council of Medical Research established the CTRI on 20 July 2007.[1] Since 2009 the Central Drugs Standard Control Organization has mandated that anyone conducting clinical trials in India must preregister before enrolling any research participants.[1]

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.[2] This statement had global influence and started conversations about clinical trial registration in India.[3][1]

The Indian Council of Medical Research established the CTRI on 20 July 2007.[1] By the end of 2007 the registry indexed 31 trials.[4] 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.[5]

The Central Drugs Standard Control Organisation made trial registration mandatory on 15 June 2009.[6] The rule was that researchers must preregister trials before the enrollment of any research participants.[6] 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.[7] There had been past calls for preregistration.[8]

Data collected

The CTRI requests all the information which the World Health Organization recommends for clinical trial registries.[9] 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.[9] The World Health Organization Registry for clinical trials helped make the Indian registry more effective.[10]

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.[11]

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.[12] One factor which introduced error into the registry include that users register their own trials, sometimes with misunderstanding or errors in their submissions.[12] 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.[12]

Research

A 2016 report found that the number of trials registered had been increasing for the past few years, with most of the increased registration being from individual investigators and students rather than pharmaceutical industry.[4]

A 2018 paper expressed that the CTRI had the benefit of preventing selective reporting of results and duplication of research.[13] It also empowered patients and the public and informed ethics committees to and researchers about current and past trials.[13]

References
  1. Rao, M. Vishnu Vardhana; Maulik, Mohua; Gupta, Jyotsna; Panchal, Yashmin; Juneja, Atul; Adhikari, Tulsi; Pandey, Arvind (1 July 2018). "Clinical Trials Registry – India: An overview and new developments". Indian Journal of Pharmacology. 50 (4): 208–211. doi:10.4103/ijp.IJP_153_18. ISSN 0253-7613. PMC 6234713. PMID 30505058.
  2. 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). "Clinical Trial Registration: A Statement from the International Committee of Medical Journal Editors". New England Journal of Medicine. 351 (12): 1250–1251. doi:10.1056/NEJMe048225. PMID 15356289.
  3. Tharyan, P (2007). "Ethics committees and clinical trials registration in India: opportunities, obligations, challenges and solutions". Indian Journal of Medical Ethics. 4 (4): 168–9. doi:10.20529/IJME.2007.066. PMID 18630235.
  4. Bhide, Shruti S; Tadvi, Firoz; Maurya, Mitesh; Bhojne, Sunil; Chandrakar, Pragya (22 October 2016). "Assessment of clinical trials registered at clinical trial registry of India over past decade: an audit". International Journal of Clinical Trials. 3 (4): 238. doi:10.18203/2349-3259.ijct20163187.
  5. 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". The Indian Journal of Medical Research. 127 (2): 104–5. PMID 18403785.
  6. Sarangi, SC; Medhi, B (August 2011). "Clinical trials in India: issues with adherence to CONSORT statements". Journal of Clinical Epidemiology. 64 (8): 925–6. doi:10.1016/j.jclinepi.2011.03.002. PMID 21704256.
  7. Kaul, Rhythma (25 October 2017). "Mandatory to register clinical trials before tests begin". Hindustan Times.
  8. Tharyan, P (February 2009). "Prospective registration of clinical trials in India: strategies, achievements & challenges". Journal of Evidence-based Medicine. 2 (1): 19–28. doi:10.1111/j.1756-5391.2009.01015.x. PMID 21348978.
  9. Chatterjee, Patralekha (August 2008). "Clinical trials in India: ethical concerns". Bulletin of the World Health Organization. 86 (8): 581–2. doi:10.2471/blt.08.010808. PMC 2649459. PMID 18797610.
  10. Tharyan, P (2006). "The WHO International Clinical Trials Registry Platform: relevance to the Indian register of clinical trials". The National Medical Journal of India. 19 (3): 161–4. PMID 16836269.
  11. Sil, Amrita; Das, NilayKanti (2013). "How to register a clinical trial in India?". Indian Journal of Dermatology. 58 (3): 235–6. doi:10.4103/0019-5154.110836. PMC 3667290. PMID 23723478.
  12. Pillamarapu, Mounika; Mohan, Abhilash; Saberwal, Gayatri (28 August 2019). "An analysis of deficiencies in the data of interventional drug trials registered with Clinical Trials Registry - India". Trials. 20 (1): 535. doi:10.1186/s13063-019-3592-0. PMC 6712861. PMID 31455366.
  13. Bhaskar, S. Bala (1 January 2018). "Clinical trial registration: A practical perspective". Indian Journal of Anaesthesia. 62 (1): 10–15. doi:10.4103/ija.IJA_761_17. ISSN 0019-5049. PMC 5787884. PMID 29416145.
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