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”.