Article type
Year
Abstract
Background: Out of all new clinical trials initiated to explore efficacy and safety of new intervention, 10-20% terminated prematurely. Looking at the altruistic motive of patients involvement in these trials and use of huge resources, premature termination of trials raised an important ethical issue. There may be some genuine reasons for premature termination of clinical trials and it is important to evaluate the reasons for termination of such trials to get understanding about current situation. There is a scarcity of data related to the reasons for termination of clinical trials being conducted in India.
Objectives: This study was conducted to evaluate reporting of various reasons for termination of clinical trials registered in Clinical Trial Registry of India.
Methods: This study was based on publicly available database, Clinical Trial Registry of India (CTRI). Data related to all the terminated trials were extracted from the CTRI. Data related to the trials characteristics like type of intervention, phase of trial, sponsor, single centre/multicentre etc were extracted. Two investigator separately assessed the reasons for the termination of clinical trials and categorized them in subheadings. Discrepancy solved by mutual consultation.
Results: All the clinical trials from the CTRI database from the inception to 18 Dec 2019 were included in the analysis. 16579 interventional clinical trials posted on results database, out of which 243 trials were listed as terminated. Out of 243 terminated trials reasons were given in only 50 (20.58%) of the them. Out of these 50, 15 (30%) reasons were related to the scientific data, 27 (54%) were related to non-scientific issues and eight reasons were unclear.
In reasons with scientific data, the most common reason was safety issues with the development product (14%) and among non-scientific data, significant delay in recruitment was most prevalent reason (16%).
Conclusions: Reporting of reasons for termination of clinical trials registered in Clinical Trial Registry of India is very poor. Administrator of the registry needs to make appropriate changes in system of registration so that most of the reasons can be reflected on the website for better transparency of data.
Patient or healthcare consumer involvement: This is study based on secondary data hence no patient or consumer was involved directly for this study.
Objectives: This study was conducted to evaluate reporting of various reasons for termination of clinical trials registered in Clinical Trial Registry of India.
Methods: This study was based on publicly available database, Clinical Trial Registry of India (CTRI). Data related to all the terminated trials were extracted from the CTRI. Data related to the trials characteristics like type of intervention, phase of trial, sponsor, single centre/multicentre etc were extracted. Two investigator separately assessed the reasons for the termination of clinical trials and categorized them in subheadings. Discrepancy solved by mutual consultation.
Results: All the clinical trials from the CTRI database from the inception to 18 Dec 2019 were included in the analysis. 16579 interventional clinical trials posted on results database, out of which 243 trials were listed as terminated. Out of 243 terminated trials reasons were given in only 50 (20.58%) of the them. Out of these 50, 15 (30%) reasons were related to the scientific data, 27 (54%) were related to non-scientific issues and eight reasons were unclear.
In reasons with scientific data, the most common reason was safety issues with the development product (14%) and among non-scientific data, significant delay in recruitment was most prevalent reason (16%).
Conclusions: Reporting of reasons for termination of clinical trials registered in Clinical Trial Registry of India is very poor. Administrator of the registry needs to make appropriate changes in system of registration so that most of the reasons can be reflected on the website for better transparency of data.
Patient or healthcare consumer involvement: This is study based on secondary data hence no patient or consumer was involved directly for this study.