Abstract
Clinical Trial Registry - India (CTRI) is an important registry for clinical trials in India. This study aims to evaluate the trials registered in India for the humanistic outcomes. Official CTRI website was used as a source of data. All the clinical trials registered in CTRI between 2008 and 2017 were considered for current study. To collect the clinical trials involving humanistic outcomes the search terms used were ‘Quality of life’ and ‘health related quality of life’. From the search results overlapping trials were excluded from the study. The information such as trial code, year of registration, health condition, type of study, type of trial, study design, title of trial, sponsor information and whether the humanistic outcome was primary or secondary objective were extracted on MS Excel sheet. The collected data was checked for its correctness and data was analysed descriptively using MS Excel. Of the total documented 8873 trials 827 were considered for the current study which accounts to 9.25%. Cancer (21.19%), Diabetes (8.6%) and Gastrointestinal Tract (7.38%) were the top three health conditions for which trials were registered. Drug (29.38%) and Ayurveda treatment (11.25%) were common intervention candidates followed by others. 47% of the registered trials dealt with retrospective data while only 36.40% with prospective data. The trials involving randomization were found to be 69.17%. Other characteristics of the trials were Government sponsored (41.11%), multi-centric (31.44), multinational (13.54%) and student thesis (30.87%). Majority of the trails evaluated had Humanistic outcomes as part of secondary objective (74.61). Trials in CTRI for humanistic outcomes have used randomization of samples and the data source was retrospective. This study also showed that the humanistic outcomes were the part of secondary objectives of the trials studied. Drugs and Ayurveda are common interventions used.
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