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Analysis of Clinical Trials in Children Registered in the Clinical Trials Registry of India

Analysis of Clinical Trials in Children Registered in the Clinical Trials Registry of India. S. Manikandan *, M. Jayanthi *, B. Gitanjali ** and G. Sivagnanam * * Indira Gandhi Medical College & Research Institute, Pondicherry, India; ** WHO-SEARO, New Delhi. Introduction.

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Analysis of Clinical Trials in Children Registered in the Clinical Trials Registry of India

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  1. Analysis of Clinical Trials in Children Registered in the Clinical Trials Registry of India S. Manikandan*, M. Jayanthi*, B. Gitanjali** and G. Sivagnanam* *Indira Gandhi Medical College & Research Institute, Pondicherry, India; ** WHO-SEARO, New Delhi

  2. Introduction • World Health Organization (WHO) established International Clinical Trials Registry Platform (ICTRP) in 2005 • 20 items are listed as Trial Registration Data Set (TRDS) which is the minimum amount of information necessary for a given trial to be considered fully registered. • India launched ‘Clinical Trials Registry-India’ (CTRI) in July 2007 to enhance transparency and accountability of trial reporting from India. • The quality of information in the registry should be good in order to satisfy the three main stakeholders, i.e., health care professionals, policy makers and trial participants.

  3. Introduction • Concerns about the conduct of clinical trials in India are growing.1 • Information provided in the trial registries is insufficient and not current; hence benefits of registries are undermined.2 • Paediatric trials are scarce due to difficulties involved in conducting them. • The need for ethical oversight of trials in India has been emphasized.1 • Hence the information in registries gains more significance with reference to trials in children. • Srivastava JS. Need for ethical oversight of clinical trials in India. Curr Sci. 2010;99:1505-7. • Moja LP et al. Compliance of clinical trial registries with the World Health Organization minimum data set: a survey. Trials. 2009;10:52.

  4. Objectives • To critically analyze the information on paediatric clinical trials in Clinical Trials Registry – India (CTRI) in terms of: information - completeness, transparency, currency and compliance with WHO’s International Clinical Trial Registry Platform (ICTRP) data set, i.e., Trial Registration Data Set (TRDS). • To suggest measures to improve the quality of CTRI. http://www.ctri.nic.in

  5. Methods • A cross-sectional study of paediatric clinical trials registered in CTRI. • Clinical trials in children < 18 years retrieved (as on 15 Aug 2010) by the keyword ‘children’ from CTRI website. • Two independent observers scored the response for each item, which was verified by a third person. • Method of scoring was defined a priori. • The completeness of reporting, appropriateness and degree of compliance of CTRI data with WHO- ICTRP items (WHO items) and CTRI-specific items were analyzed. 

  6. Results Completeness of Information • 20 (25%) trials were completed; only 2 provided the results; 2 provided conclusions . • Fax number and affiliation of the Principal Investigator were not given in ~ 90% of trials. • Many participant countries have been left out. • Duration and frequency of drug administration was missing in 27% of trials.

  7. Incomplete information - A few examples Name of Institute ? Reproduced from CTRI. Comments of authors are in red.

  8. Incomplete information - a few examples Placebo has same constituents as test drug ?? Reproduced from CTRI. Comments of authors are in red.

  9. Results Transparency of information • 3 (4%) trials have not disclosed the sources of monetary & material support. • 41 trials needed regulatory approval, but only 32 have obtained it. • Inconsistencies in the no. of sites, blinding etc. Reproduced from CTRI. Comments of authors are in red.

  10. Lack of transparency - examples Reproduced from CTRI. Comments of authors are in red.

  11. Results Currency of information • 31 (38%) trials were updated after registration whereas 7(9%) were not. • Remaining 43 (53%), the date of last update is prior to the date of registration. Reproduced from CTRI. Comments of authors are in red.

  12. ResultsCompliance with WHO items (n=20) in CTRI

  13. ResultsCompliance with CTRI-specific items (n=13)

  14. ResultsUnethical use of placebo in registered trials

  15. Discussion • Though the quantum of compliance is satisfactory in CTRI, the quality is found wanting. Suggestions to improve CTRI • Regular reminder to the registrants to update results and information on completion of trial. • Errors in the date of update can be rectified through changes in the software. • Ethical issues like the inappropriate use of a placebo should be taken up with the principal investigators before registering the trial. • Summary of the clinical trials should be in English as well as vernacular – to help participants. • Separate link to be provided for children’s trials.

  16. Conclusion • The information on children’s clinical trials in the CTRI is incomplete, not current, not regularly updated, and at times misleading. • The use of placebo is not justified in one third of the placebo-controlled trials in children. • The quality of information in CTRI may be improved by modifying the registry and making it user friendly and by providing assistance for registration.

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