CLINICAL TRIALS WATCH

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This is the third factsheet collating data on clinical trials in India. The first and second factsheets were published in the October 2009 and April 2010 issues of the journal respectively. The cut-off date for the data collated for the first factsheet was June 15, 2009, coinciding with the Drugs Controller General of India's mandate for compulsory registration of clinical trials with sites in India. While the first factsheet contained data on two registries, it was decided to restrict data collection to the Indian registry Clinical Trials Registry-India (CTR-I, www.ctri.in ).

In the six month period from June 15, 2009, when registration was made compulsory, to December 31, 2009, when data for the second factsheet were collated, the Indian registry, ctri.gov, recorded a marked increase in registration of clinical trials, from 324 to 689. A similar marked increase - to 1,078 trials - is seen in this third factsheet that records data on all registered trials as of June 30, 2010. As with previous factsheets, the majority (666/1,078) are drug trials.

Methods

CTR-I yielded 1,078 registered trials on June 30, 2010. The information on each registered trial was manually exported into an Excel spreadsheet via the copy-paste mechanism of Microsoft Office. The fields of information exported included CTR-I ID, brief study title, study status, trial location, ethics committee details, sponsor, disease condition, trial start date, DCGI approval and study type. This Excel spreadsheet was then exported to SPSS for analysis.

Definitions

Year: CTR-I provides a record of the last date on which the study was verified, the date on which the study was updated and the date of first enrolment for each trial. The date of first enrolment was coded as the "year" for each trial.

Study type: The trials listed in the CTR-I were classified according to the different types of studies as "drug", "behavioural", "device", "procedure", "radiation", and "other" after careful reading of the study title. These codes were in line with the classification for different types of trial intervention listed on Clinicaltrials.gov.

Disease condition: The disease conditions were coded according to the 10th revision of the World Health Organization (WHO) International Classification of Diseases (ICD 10). There were 18 categories including diseases of the nervous system, circulatory system and digestive system. An additional category for "double disease conditions" was created to include combinations of the disease conditions involved in the trial. After running the frequencies for all disease conditions, only the prominent ones were chosen for representation, while the less significant categories were truncated and labeled as a separate category referred to as "other."

Sponsors: Sponsors were categorised as: Indian and non-Indian; private, public and non-profit; and, lastly, institution/ agency and pharmaceutical company. Trials starting before 2006 were combined with trials starting in 2006 in CTR-I All the data pertaining to phase, disease condition, sponsor, study type, recruitment status, and location (by cities and states) have been analysed by "year".

Drug trial setting: This refers to the institution where the trial site was located. The city/town in which this institution is located was coded. Similarly, the state in which this institution is located was coded. Each "drug trial setting" represents a single trial site. Thus, each trial can have multiple "drug trial settings". Likewise, the same city may be listed more than once for the same trial, depending on the number of institutions from that city participating in that trial. This variable was coded only for those trials categorised as "drug trials" in study type. In this factsheet, the data on drug trial settings has been reported in more detail. All cities/towns reporting more than 20 trials, over the entire period, have been listed separately. Likewise, all states reporting a significant number of trials have been listed. The remaining have been clubbed into a category called "others".

Total number of trials registered Clinical trials registry - India, N = 1078

Year missing 2006 & prior 2007 2008 2009 2010

Number of Trials

4

64

111

229

425

245

Recruitment status
Year missing 2006 & prior 2007 2008 2009 2010

Completed

1

38

30

44

73

8

Not yet recruiting

1

15

24

57

109

79

Recruiting

1

9

51

123

235

127

Terminated

1

2

5

5

6

Temporary halt or suspended

1

2

Total

4

64

111

229

425

214

Type of study
Year missing 2006 & prior 2007 2008 2009 2010

Behavioral

5

2

7

1

Device

3

4

8

11

7

Dietary supplement

1

3

5

11

6

Drug

3

31

73

142

285

132

Procedure

3

4

17

11

3

Radiation

2

2

4

Biological

1

16

21

43

79

78

Gene transfer

Other

3

6

12

19

14

Total

4

64

111

229

425

245

Disease conditions

Year missing

2006 & prior

2007

2008

2009

2010

Bacterial infections, intestinal infections, STDs

1

4

10

19

45

50

Neoplasms

10

29

37

44

24

Endocrine, nutritional, and metabolic

6

5

30

55

27

Mental and behavioral diseases

3

2

4

25

8

Diseases of the nervous system

4

10

18

29

7

Diseases of the circulatory system

2

10

29

46

25

Diseases of the respiratory system

2

2

3

12

25

7

Diseases of the digestive system

4

13

11

20

20

Diseases of the musculoskeletal system and connective tissue

3

5

6

28

15

Diseases of the eye and adnexa

4

2

7

14

6

Diseases of the genitourinay system

3

4

8

22

15

Diabetes

Pregnancy, Childbirth and the puerperium

4

5

7

3

4

Double disease condition

1

9

5

12

15

3

Other

4

7

27

48

32

Disease conditions not known

1

1

2

7

2

Total

4

63

111

229

426

245

Sponsor Ownership

Year missing

2006 & prior

2007

2008

2009

2010

Public

20

21

27

39

21

Private

4

32

63

156

343

191

Non-profit

2

6

16

9

9

Public, private

2

2

11

4

Non-profit, public

1

Non-profit, private

1

3

1

3

2

Mixed

Individual investigator

3

3

10

7

6

Individual investigator, public

1

2

1

2

1

Individual investigator, non-profit

1

1

1

Sponsor ownership not known

2

12

14

11

10

Total

4

64

111

229

425

245

Sponsor Profile

Year missing

2006 & prior

2007

2008

2009

2010

Institution/Agency

33

37

62

63

47

Pharma

4

29

62

151

350

186

Both

Sponsor profile not known

2

12

16

12

12

Total

4

64

111

229

425

245

Phases

Year missing

2006 & prior

2007

2008

2009

2010

0

I

1

7

33

20

II

2

9

23

46

66

30

III

2

25

43

99

200

111

IV

8

10

32

51

26

I/II

4

1

5

10

5

II/III

4

14

12

17

13

III/IV

2

7

2

8

5

not applicable

11

13

23

37

35

Phase not known

3

3

Total

4

64

111

229

425

245

Sampling

Year missing

2006 & prior

2007

2008

2009

2010

Cross sectional

Non-randomised

3

4

5

6

8

Prospective

Randomised

4

50

91

162

327

171

Cluster

3

1

1

Other

7

12

33

35

26

sampling not known

4

4

26

56

39

Total

4

64

111

229

425

245

Assignment

Year missing

2006 & prior

2007

2008

2009

2010

Crossover

1

2

2

5

24

9

Factorial

3

2

2

Parallel

3

51

90

162

305

168

Single group

4

3

25

54

39

Other

7

12

36

39

27

Assignment not known

1

1

1

Total

4

64

111

229

425

245

Control

Year missing

2006 & prior

2007

2008

2009

2010

Active

25

31

68

148

96

Placebo

3

20

46

74

121

46

Uncontrolled

4

3

25

54

39

Multi-arm

6

13

20

36

26

Crossover

1

2

2

5

24

9

Other

7

12

33

35

26

Control not known

4

4

7

3

Total

4

64

111

229

425

245

Clinical trials registry - India

Total number of drug trial settings N = 4292

Year missing 2006 & prior 2007 2008 2009 2010

Number of drug trial settings

Drug trial settings by states (in alph. order)

Andhra Pradesh
1

14

51

88

216

74

Bihar
1

2

8

16

9

Delhi

1

14

47

60

141

65

Gujarat 11 18 46 210 132

Haryana
1

3

6

18

8

Karnataka
3

13

64

120

321

96

Kerala
1

2

20

50

62

17

Madhya Pradesh
3

5

20

63

32

Maharashtra
4

29

98

215

531

239

Punjab
1

4

11

21

32

7

Rajasthan
1

3

13

42

83

44

Tamil Nadu
1

13

51

89

176

59

Uttar Pradesh
1

10

28

67

36

West Bengal
3

16

30

45

32

Others

11

1

11

19

30

32

24

113

420

842

2011

882

Drug trial settings by cities/towns (in alph. order)

Ahmedabad
10

14

34

139

67

Aurangabad
5

34

9

Bangalore
3

41

82

215

52

Bhopal
3

5

12

6

Chandigarh
1

5

8

13

6

Chennai
5

21

44

94

37

Cochin
1

7

22

20

5

Coimbatore

1

3

5

16

31

5

Hyderabad
1

13

46

68

160

45

Indore
3

2

14

43

24

Jaipur
1

3

11

38

79

27

Kolkata
3

16

29

43

20

Lucknow
8

12

32

18

Ludhiyana
1

2

6

15

21

4

Madurai
2

3

11

22

3

Mangalore
2

12

13

61

14

Manipal
2

3

5

11

3

Mumbai
1

17

51

89

176

112

Mysore
3

3

13

18

7

Nagpur
5

22

59

24

Nasik
10

52

26

New Delhi
1

15

47

68

146

60

Patna
1

1

7

13

4

Pune
3

11

41

79

189

38

Surat
1

1

16

16

Trivandrum
2

11

18

31

6

Vadodara
1

2

7

28

16

Vellore
2

23

13

18

4

Vijayawada
7

13

6

Visakhapatnam
2

2

10

21

10

Others
83

6

37

77

186

148

92

114

426

842

1996

822