CLINICAL TRIALS WATCH

DOI: https://doi.org/10.20529/IJME.2010.103


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
Number of Trials Year missing 2006 & prior 2007 2008 2009 2010
  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 6 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
About the Authors

Editorial Team ()

Keywords

N/A

Refbacks

There are currently no refbacks.