This is the second fact-sheet of Clinical Trials Watch. CTW, which was first published in the October-December 2009 issue of IJME, aims to employ the Clinical Trials Registry-India (CTR-I) for regular monitoring of clinical research activity in India.

The fact-sheet initially presented information from two registries, the Indian Council of Medical Research’s Clinical Trials Registry-India (CTR-I), www.ctri.in , and the US National Institutes of Health’s registry, www.clinicaltrials.gov .

On July 1, 2009, the Drugs Controller General of India (DCGI) made registration of all drug trials being conducted in India mandatory. As a result, there was a twofold increase in the number of trials registered on www.ctri.in between June 2009 and December 2009. Thus, this database is now more representative of the clinical research scenario in India. For this reason, from this point on, we will be presenting data only from CTR-I. The data presented in this fact-sheet are updated up to December 31, 2009. All the registered trials on www.ctri.in were revisited and information was revised to ensure that changes made in the record of each trial in the registry were incorporated in the database.

Methods

The Indian registry yielded 689 registered trials on December 31, 2009. Trial information pertaining to each registered clinical 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”.

Compiled by Deapica Ravindran [email protected] and Sachin Nikarge [email protected] with assistance from Maulik Mavani, 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.