Clinical Trials Registry – India

Clinical Trials Registry – India (CTRI) is the government of India's official clinical trial registry.

In April 2018 the Indian government made the registration of clinical trials in India mandatory.[1]

By the end of 2007 the registry indexed 31 trials.[2] A 2016 report found that the number of trials registered increased every year thereafter, with most of the increased registration being from individual investigators and students rather than pharmaceutical industry.[2]

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.[3] One factor which introduced error into the registry include that users register their own trials, sometimes with misunderstanding or errors in their submissions.[3] 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.[3]

The recommendations which the International Committee of Medical Journal Editors made for clinical trial registries in 2005 were a precedent to India's establishing the CTRI.[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]

A 2018 paper expressed that the CTRI had the benefit of preventing selective reporting of results and duplication of research.[6] It also empowered patients and the public and informed ethics committees to and researchers about current and past trials.[6]

A review of the registry made the recommendation that researchers in doubt of whether to register their research should attempt to register in CTRI.[7]

The World Health Organization Registry for clinical trials helped make the Indian registry more effective.[8]

References
  1. Kaul, Rhythma (25 October 2017). "Mandatory to register clinical trials before tests begin". Hindustan Times.
  2. 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.
  3. 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). doi:10.1186/s13063-019-3592-0. PMID 31455366.
  4. 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. doi:10.4103/ijp.IJP_153_18. ISSN 0253-7613. PMC 6234713. PMID 30505058.
  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. Bhaskar, S. Bala (1 January 2018). "Clinical trial registration: A practical perspective". Indian Journal of Anaesthesia. 62 (1): 10. doi:10.4103/ija.IJA_761_17. ISSN 0019-5049. PMID 29416145.
  7. 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.
  8. 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.
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