This is the third factsheet collating data on clinical trials in India from the Clinical Trials Registry of India (CTR-I). The CTR-I is a dynamic database, where users can add, edit and remove records. Thus, there are constant changes in the data available on the registry. The data presented in this factsheet are based on a manual database which has been developed by downloading information for the CTR-I website and entering it into a spreadsheet. As this process takes place over a period of time, the data presented here are merely indicative of the trend.

During the early part of 2011, the CTR-I database was overhauled and thus data presented in the earlier factsheets are not comparable with the data presented in this fact-sheet.

In this factsheet, the data presented pertain only to active trials which are open to recruitment registered with the CTR-I between January 1, 2007 and December 31, 2010. These data were downloaded and entered into a database between April and May 2011.

Definitions used in this fact-sheet remain the same as used in the earlier factsheet published in the October-December 2010 issue of the Indian Journal of Medical Ethics.

There was a total of 670 active trials registered between January 1, 2007, and December 31, 2010, which were open to recruitment at the point of database development (April-May 2011).

Clinical Trials Watch
Disease	Sponsor Profile
	Pharma	Institute	Others
Certain infectious and parasitic diseases	29	24	1
Diseases of the blood and bloodforming organs and certain disorders involving the immune mechanism	20	8	1
Diseases of the circulatory system	67	19	2
Diseases of the digestive system	28	16	3
Diseases of the nervous system	26	10	5
Endocrine, nutritional and metabolic diseases	63	13	3
Healthy volunteers	13	2	0
Neoplasms	100	20	5
Pregnancy, childbirth and the puerperium and perinatal conditions	2	16	7
Other diseases	108	35	24
Total	456	163	51

Trial type	Institute	Pharma	Not given
Placebo controlled trial	44	136	10
Active controlled trial	62	136	18
Single arm trial	17	59	10
Crossover trial	2	14	1
Multiple arm trial	16	53	2
Cluster randomised trial	2	0	0
Others	20	58	10
Total	163	456	51

Sponsor nationality	Phase I	Phase II	Phase III	Phase IV	Others
Foreign	13	67	164	30	18
Foreign, Indian	1	13	32	2	5
Indian	35	55	96	35	58
Not given	3	5	9	9	20
Total	52	140	301	76	101

It is interesting to note that 68% (456) of the total trials were sponsored by pharmaceutical companies alone, with the highest number of trials (100) being related to cancers (neoplasms). The other major focus areas for pharmaceutical industry-sponsored research were diabetes and cardiovascular diseases.

A significant proportion of registered trials were placebo controlled (28%), a large number of them being sponsored by pharmaceutical companies. On the other hand, there were only two cluster randomised trials registered, indicating that such research has not yet come into the purview of the CTR-I.

A substantial number of phase III trials are being carried out using foreign funding (164) as against Phase III trials receiving funding from India (96). This is in keeping with the observation that India has become a preferred destination for outsourcing clinical research because of its large treatment-naÃ¯ve patient population.

An overview of the presented data indicates that there is an overwhelmingly high proportion of privately funded and pharmaceutical-placebo controlled-phase III trials, representing the current trend of clinical trial research in India.

Compiled by Chitra Borkar, Vivian David Jacob and
Deapica Ravindran with assistance from Kinjal Vaid,
Centre for Studies in Ethics and Rights, Mumbai