Clinical trials in India: Where do we stand globally?

Abstract

Aims:To evaluate the trend of clinical trials in India over the last 4 years compared to the well-established countries using clinical trial registries since the advent of clinical trial registry of India (CTRI).Materials and Methods:The data of clinical trials registered in India, United States (US), and European Union (EU) were obtained from websites of CTRI, clinicaltrial.gov and EU clinical trial registry, respectively from July 20, 2007 to August 29, 2011 for a period of 4 years. Trials registered in Australia, Canada, China, and Japan were obtained from WHO's international clinical trial registry platform for the same period. We used search words for the common diseases such as diabetes, hypertension, etc.,Results:The total number of clinical trials registered during the study period was 67,448 across seven study nations. Clinical trials from India constituted only 2.7% of the total number of trials carried out, compared to US constituting 47% of the total number of trials registered, followed by 18% from EU and 11% from Japan. However, India, China, and Japan have been found to show an increase of 3.7%, 5.1%, and 13.1% increase in the number of trials registered in 2011 compared to 2007. In contrast, US and EU showed a decline of 11.3% and 11.95% respectively in the total number of trials registered in 2011 compared to 2007.Conclusions:Although India shows gradual increase in trials registered since the advent of CTRI, still it continues to lag behind established countries in clinical research.

Is off-label use a risk factor for adverse drug reactions in pediatric patients? A prospective study in an Indian tertiary care hospital

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Clinical trials in dentistry in India: Analysis from trial registry

“…An analysis of CTRI for trials registered in the field of medicine has also lead to a similar conclusion where the authors have reported that India is contributing only to 2.7% of the global clinical trials. [9] Lack of trained researchers in dentistry and sponsors (both private and government), poor patient awareness about clinical trials in India reducing the chance of their recruitment are some of the speculations for the low rate of dental clinical trials in India. Furthermore, the present study found a poor quality reporting of methods in the dental clinical trials.…”

Solving clinical trial delays: innovative solutions

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“…Several processes in CDM such as Case Report Form (CRF) designing, CRF annotation, database designing, data-entry, data validation, discrepancy management, medical coding, data extraction and database locking affects the delivery of the trial [35]. The traditional method of data collection is to employ paper CRFs, which are filled up by the site coordinator according to the CRF completion guidelines and then entered/translated in the database.…”