Indian Journal of Medical Ethics

CLINICAL TRIALS WATCH

DOI: https://doi.org/10.20529/IJME.2009.082


Total number of trials registered Clinical trials.gov, N = 1040 Clinical trials registry – India N = 324
  Year missing 2003 & prior 2004 2005 2006 2007 2008 Jun-09 Year missing 2006 & prior 2007 2008 jun-09
Number of Trials 21 103 79 118 183 226 225 85 3 27 67 129 98
Recruitment status                          
Active,not recruting 3 18 8 16 41 44 33     8 8 10 4
Completed 8 68 57 63 81 67 23     17 14 7 2
Enrolling by invitation         1 3 8 2          
Not yet recruiting 2       2 5 4 27     2 20 26
Recruiting 3 14 7 26 50 90 154 54   2 43 91 66
Suspended           4              
Temporarily not available               1          
Terminated   3 7 13 8 12 2         1  
Withdrawn           1 1 1          
Recruitment status not known 5               3        
Total 21 103 79 118 183 226 225 85 3 27 67 129 98
Type of study                          
Behavioural 1 6 3 2 3 4 3 1   2   2 1
Device   2 1 6 10 12 8 2   2   2 1
Dietary supplement   1   2 2 7 2       2    
Drug 10 70 65 87 146 176 173 59   18 59 104 85
3 7 3 7 8 4 5 6   2 4 14 6  
Radiation   1   3   1 1     1      
Biological   3 1 5 1 20 17 9          
Gene transfer     1                    
Other   4 1 2 2 4 5 3   2 4 5 5
Not given 7 9 4 4 4 3 6 3 3        
Total 21 103 79 118 183 226 225 85 3 27 67 129 98
Disease conditions                          
Bacterial infections, intestinal infections, STDs 7 25 6 20 24 31 28 11   3 7 12 10
Neoplasms 5 23 14 24 43 44 44 12   2 21 20 14
Endocrine, nutritional, and metabolic                   1 1 19 11
Mental and behavioural diseases   2 5 9 4 12 7 2          
Diseases of the nervous system     9 4 11 20 11 2     3 11 5
Diseases of the circulatory system   7 8 14 19 29 28 13   2 5 12 14
Diseases of the respiratory system   9 6 4 7 6 6 8     3 10 10
Diseases of the digestive system   4 4 6 8 10 3 6   3 5 6 6
Diabetes   6 4 9 28 17 46 16          
Double disease condition 1 10 6 7 4 16 5 3   5 5 5 5
Other 3 17 17 21 35 41 47 12   10 6 8 21
Disease conditions not known 5               8        
Total 21 103 79 118 183 226 225 85 8 27 65 129 95
Sponsor nationality                          
Indian 2 23 19 26 34 32 34 20   20 44 75 45
Non-Indian 13 67 54 81 139 183 180 61   5 13 41 49
Indian and Non-Indian 1 13 6 11 10 11 11 4   1   3  
Sponsor nationality not known 5               28        
Total 21 103 79 118 183 226 225 85 28 26 57 119 94
Sponsor ownership                          
Public 8 28 12 16 21 17 21 12   7 15 19 9
Private 5 54 55 72 148 185 188 67   12 31 79 78
Non-profit   4 5 10 3 6 4     2 5 12 3
Public, private 1 3 1 5 2 9 3 2         1
Non-profit, public   2 1 4 1 1 1         1  
Non-profit, private   1   1 1 1 2       2   1
Mixed 2 11 5 10 7 7 6 4          
Individual investigator                   3 2 8 2
Individual investigator, public                     1    
Individual investigator, non-profit                     1    
Sponsor ownership not known 5               30        
Total 21 103 79 118 183 226 225 85 30 24 57 119 94
Sponsor profile                          
Institution/Agency 11 59 28 45 47 46 43 19   17 26 42 14
Pharma 5 43 49 68 136 177 178 64   8 31 77 80
Both   1 2 5 3 4 2            
Sponsor profile not known 5               29        
Total 21 103 79 118 183 226 225 85 29 25 57 119 94
Phases                          
0             1            
I 1 6 3 3 5 4 7 3       4 9
II 3 11 11 26 28 43 41 12   2 16 26 14
III 5 46 34 54 105 123 120 28   13 25 53 40
IV 1 11 10 13 11 18 14 19   5 5 17 19
I/II 1 3 1 1 7 7 5   2   3 6  
II/III 1 5 3 4 7 9 8 3   1 9 6 5
III/IV                     4 2  
not applicable                   4 8 18 5
Not given 10 23 15 17 26 22 27 15 3        
Total 21 103 79 118 183 226 225 85 3 27 67 129 98
Sampling                          
Cross sectional           1              
Non-randomised 3 6 11 15 21 29 18 7   1   3 2
Prospective   2 2 6 9 3 10 11          
Randomised 11 80 61 92 148 185 170 57   21 56 96 80
Retrospective     1                    
Convenience   1 1                    
Defined population   1 2 1 1                
Cluster                       1  
Other                   3      
Not given 7 13 1 4 4 8 27 10 35   7 17 2
Total 21 103 79 118 183 226 225 85 35 25 63 117 84
Assignment                          
Crossover 6 3 4 12 5 4 4   2 2 4 6  
Factorial   7 1 5 3 1 3       1    
Parallel 9 61 51 81 134 183 171 55   19 53 92 74
Single group 5 10 17 18 24 32 33 14   2 3 12 14
Other                   3 7 17 2
Not given 7 19 7 10 10 5 14 12 11        
Total 21 103 79 118 183 226 225 85 11 26 66 125 96
Control                          
Active 5 44 22 40 71 79 55 16   10 17 38 38
Case control       1   3 4 2          
Cohort   1 2 3 7   3 7          
Cross sectional   1 2 1 1 1              
Dose comparison   4 3 1 4 7 5 1          
Historical       1 3 4 1            
Longitudinal   1 1                    
Placebo 3 18 23 33 45 50 59 12   8 28 44 29
Uncontrolled 3 4 10 11 13 15 14 4   2 3 12 14
Multi-arm                   2 8 13 9
Crossover                   2 2 4 6
Other                   3 7 17 2
Not given 10 30 16 27 39 68 83 43 6        
Total 21 103 79 118 183 226 225 85 6 27 65 128 98
 
Total number of drug trial settings N = 3884 N=1432
2003 & prior 2004 2005 2006 2007 2008 Jun-09   2006 & prior 2007 2008 Jun-09    
Number of drug trial settings 29 231 229 443 854 904 994 200   42 280 520 590
Total number of drug trials N = 786 N = 266
2003 & prior 2004 2005 2006 2007 2008 Jun-09   2006 & prior 2007 2008 Jun-09    
Number of drug trials 10 70 65 87 146 176 173 59   18 59 104 85
Top drug trial settings by cities                          
Mumbai 2 33 31 54 101 99 103 12   1 31 54 44
Bangalore 2 25 34 57 83 99 118 15   1 12 50 56
Delhi 6 29 27 52 58 83 85 15   16 35 43 39
Hyderabad 1 21 27 47 79 81 73 16   6 18 46 45
Pune 3 13 15 28 71 71 73 13   2 20 34 25
Others 15 110 95 205 462 471 542 129   16 164 293 381
Top drug trial settings by states                          
Maharashtra 5 50 46 87 206 197 226 37   2 65 110 151
Karnataka 2 29 42 76 122 141 175 23   6 36 87 90
Tamil Nadu 5 33 25 56 100 90 105 27   7 40 66 74
Andhra Pradesh 1 23 28 60 103 110 100 21   5 21 60 53
Delhi 6 29 27 52 58 83 85 15   14 35 40 51
Others 10 67 61 112 265 283 303 77   8 83 157 171

The launch of the Clinical Trials Registry-India (CTR-I) provides an opportunity for one-point registration and tracking of clinical research activity in India. However, this resource has remained unexplored ever since the launch of CTR-I on July 20, 2007.

The objective of this new column, Clinical Trials Watch, is to employ CTR-I for regular monitoring of clinical research activity in India. It will therefore publish information on select indicators extracted from CTR-I on a regular basis.

Clinical Trials Watch will also publish parallel information on Indian clinical trials extracted from www.clinicaltrials.gov, a registry managed by the National Library of Medicine at the United States National Institutes of Health. This information is being included to broaden the database for monitoring clinical research in India.

We also hope that publishing parallel indicators from a relatively more established registry enables a comparative evaluation of the functioning and operational aspects of CTR-I. With the current Drugs Controller General of India (DCGI) mandating registration of all clinical trials, it may be only a matter of time before the registration of trials catches up on CTR-I. That however will be an issue to examine for the next factsheet of Clinical Trials Watch, which will appear in the April 2010 issue of IJME.

Methods

For clinicaltrials.gov, a search was conducted for all trials with the keyword “India”. This yielded 1,040 search results on June 15, 2009. The results were downloaded from www.clinicaltrials.gov in excel and xml format. The excel spreadsheet of 1,040 clinical trials, automatically generated from the website, contained the following fields in the columns: National Clinical Trials Identifier (NCT ID); brief study title; recruitment status; disease conditions; intervention type; sponsor type; phases; study start date and study design. The xml files contained the same fields but also contained many text-heavy fields that included study objectives, rationale, inclusion and exclusion criteria, disease characteristics and study locations. From the xml files, a second excel spreadsheet was generated by extracting only the NCT ID, study location, city and state information. The data from the two excel spreadsheets were merged.

The Indian registry yielded 324 registered trials on June 30, 2009. Trial information pertaining to each registered clinical trial was manually exported into an excel spreadsheet using a template. The fields of information exported were CTR-I ID, brief study title, study status, trial location, ethics committee details, sponsor, disease condition, trial start date, DCGI approval and study type.

All data were then exported to SPSS for analysis. Categories presented in the tables are as given in the original datasets. In some cases, the variables were recoded to ensure comparability across two data sets. Details of recoded variables are given in the notes.

This factsheet has been prepared at the Centre for Studies in Ethics and Rights, Mumbai. CSER thanks Prof Roger Jeffery, department of sociology, University of Edinburgh, UK for making available financial support for the project.

The authors acknowledge Amar Jesani and Neha Madhiwalla for their guidance in the preparation of this column.

Prepared by Sachin Nikarge sachinikarge@yahoo.com and Divya Pamnani pamnani.divya@gmail.com

Notes: recoded variables

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. Clinicaltrials.gov provides a record of the study start date, the date on which information was first received on the registry, as well as the date of trial completion, “last updated”, and “last verified” dates. The study start date was coded as the ‘year’ for each trial.

As the numbers were very small, trials starting in the year 2003 or earlier were combined into one category for the trials listed in Clinicaltrials.gov. Similarly, trials starting in 2006 or earlier were combined into one category for the trials listed in CTR-I.

Disease conditions: 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 in the ICD 10, including diseases of the nervous system, circulatory system and digestive system. To these categories, a new category, “double disease conditions”, was added to include combinations of the disease conditions involved in the trial. After running the frequencies for all disease conditions, only the prominent categories were chosen for representation. The less significant categories were clubbed as a separate category named “other.”

Type of study: In Clinicaltrials.gov, all trials were pre-coded according to the type of study as “drug”, “behavioural”, “device”, “procedure”, “radiation”, and “other”. The same classification was used to recode the trials listed on CTR-I after a careful reading of each study title.

Sponsors were categorised as: Indian and non-Indian; private, public and non-profit; and, lastly, institution/agency and pharmaceutical company.

Drug trial setting: This refers to the city or state where the site of a drug trial (as defined in “type of study”) was located. An analysis of the locations of trials was conducted only for drug trials.