Clinical trials in India: Where do we stand globally?
Sandhiya Selvarajan1, Melvin George, Suresh S Kumar
1Department of Clinical Pharmacology, JIPMER, Puducherry, India.
Perspectives in Clinical Research
|September 7, 2013
Summary
India
Area of Science:
- Clinical research trends
- Global clinical trials
- Regulatory landscape
Background:
- The Clinical Trial Registry of India (CTRI) was established to improve transparency and accessibility of clinical trial information.
- Understanding the growth trajectory of clinical trials in India is crucial for assessing its position in global pharmaceutical research.
Purpose of the Study:
- To evaluate the trend of clinical trials in India over the last 4 years.
- To compare India's clinical trial landscape with established countries like the US and EU.
- To analyze clinical trial registration data since the inception of CTRI.
Main Methods:
- Data on clinical trials registered in India, US, and EU were collected from CTRI, clinicaltrial.gov, and EU clinical trial registry, respectively.
- Data from Australia, Canada, China, and Japan were sourced from the WHO's international clinical trial registry platform.
- The study period spanned from July 20, 2007, to August 29, 2011, covering four years. Search terms included common diseases like diabetes and hypertension.
Main Results:
- A total of 67,448 clinical trials were registered across seven nations during the study period.
- India accounted for only 2.7% of all registered trials, significantly lower than the US (47%) and EU (18%).
- India, China, and Japan showed an increase in registered trials (3.7%, 5.1%, and 13.1% respectively) in 2011 compared to 2007, while the US and EU experienced a decline (11.3% and 11.95%).
Conclusions:
- Despite a gradual increase in registered trials since CTRI's inception, India's clinical research output still lags behind established nations.
- The findings highlight the need for strategies to boost clinical trial activity and competitiveness in India.
- The comparative analysis provides insights into global clinical trial dynamics and regional growth patterns.
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