Open Access Journal of Clinical Trials (Dec 2020)

Terminated Interventional Trials in the Clinical Trial Registry of India Database: An Analysis to Evaluate the Reasons for Termination

  • Dutta S,
  • Kaur R,
  • Haque M,
  • Bhardwaj P,
  • Saxena D,
  • Rahman NAA,
  • Lugova H,
  • Jahan D,
  • Islam S,
  • Chowdhury TS,
  • Charan J

Journal volume & issue
Vol. Volume 12
pp. 61 – 70

Abstract

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Siddhartha Dutta,1 Rimplejeet Kaur,2 Mainul Haque,3 Pankaj Bhardwaj,4 Deepak Saxena,5 Nor Azlina A Rahman,6 Halyna Lugova,7 Dilshad Jahan,8 Salequl Islam,9 Tajkera Sultana Chowdhury,10 Jaykaran Charan1 1Department of Pharmacology, All India Institute of Medical Sciences, Jodhpur, Rajasthan, India; 2Department of Pharmacology, Dr. S.N Medical College, Jodhpur, Rajasthan, India; 3The Unit of Pharmacology, Faculty of Medicine and Defence Health Universiti Pertahanan, Nasional Malaysia (National Defence University of Malaysia), Kuala Lumpur, Malaysia; 4Department of Community and Family Medicine, All India Institute of Medical Sciences (AIIMS), Jodhpur, Rajasthan, India; 5Indian Institute of Public Health (IIPH) Gandhinagar, Gujarat, India; 6Department of Physical Rehabilitation Sciences, Kulliyyah of Allied Health Sciences, International Islamic University Malaysia, Kuantan, Malaysia; 7The Unit of Community Medicine, Faculty of Medicine and Defence Health, National Defence University of Malaysia, Kuala Lumpur, Malaysia; 8Department of Hematology, Gandaria Beside Dhupkhola, Asgar Ali Hospital Ltd, Dhaka, 1204, Bangladesh; 9Department of Microbiology, Jahangirnagar University, Savar, Dhaka 1342, Bangladesh; 10Department of Urology, Shaheed Suhrawardy Medical College Hospital, Dhaka 1207, BangladeshCorrespondence: Mainul HaqueThe Unit of Pharmacology, Faculty of Medicine and Defence Health Universiti Pertahanan, Nasional Malaysia (National Defence University of Malaysia), Kem Perdana Sungai Besi, Kuala Lumpur 57000, MalaysiaTel +60 109265543Email [email protected]: Clinical Trial Registry - India (CTRI) is a valuable tool to access information regarding clinical trials conducted in India. To serve this purpose, the information provided on it must be complete and accurate. The present study was designed to assess the reasons for premature termination of clinical trials on the CTRI database and determine the average timings related to updating information on CTRI.Methods: The data were extracted from the website of Clinical Trial Registry - India; all the terminated trials from 20 July 2007 to 18 December 2019 were included. The reasons given for termination were categorized as scientific reasons, nonscientific reasons, and unspecified reasons.Results: Of 16,579 interventional clinical trials, 243 trials were terminated. Out of these 243 trials, reasons were given in 50 (20.58%). In reasoning with scientific data, the most common reason was safety issues (14%), and among nonscientific data, a significant delay in recruitment was a principal reason (16%). The median time from date of registration to date of modification was 1034 days (0– 3912), and the median time from the date of last revision to the date of our analysis was 1329 days (2– 3138).Conclusion: The reasons for termination are not mentioned adequately for the terminated clinical trials in the Clinical Trial Registry of India. Efforts need to be done to motivate investigators to report the reasons for termination. Proper planning of trial before initiation may prevent premature termination of clinical trials and ensure fair use of resources.Keywords: Clinical Trial Registry of India, terminated trials, reasons for premature termination

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