The Clinical Trial Registry of India (CTRI) has witnessed a marked increase in the number of registration of clinical trials in the country ever since the registration was made mandatory by the then drugs controller general of India (DCGI) three years ago. More than 2700 trials were registered so far with CTRI since the registration of trials was made mandatory in June, 2009.
The spurt in the number of registration of trials can be gauged from the fact that more than 2700 trials were registered during the last three years against the 298 clinical trials registered during the two years before the registration was made mandatory in the country on June 15, 2009.
CTRI coordinator Dr Abha Agarwal said that ever since the registration was made mandatory from June 15, 2009 by the then DCGI Dr Surinder Singh, there has been a marked increase in the number of registration of clinical trials in the country. The DCGI made registration of clinical trials mandatory as part of streamlining the clinical trials sector in the country.
Registration of clinical trial was only voluntary till early 2009 in the country. That the clinical trial organisations were not much interested in registration of trials for obvious reasons was clear from the fact that the total number of trials registered from July 2007, when the Registry was launched in the country, to December 2007 was just 11. In the year 2008, the number of registration went up to 137, still far from the desired level, given the size of the clinical trials going on in the country. From January 1 to June 15, 2009, the total number of trials registered was just around 150.
The CTRI was set up by the National Institute of Medical Statistics (NIMS) which is an arm of Indian Council of Medical Research (ICMR) and is funded by the Department of Science and Technology (DST) through ICMR. It also receives financial and technical support through the WHO, WHO-SEARO, and the WHO India Country office.
The main objective of the CTRI is to ensure that every clinical trial conducted in the region is prospectively registered with full disclosure of the 20-item WHO ICTRP dataset, as well all items of the CTRI dataset, in order to improve transparency and accountability; improve the internal validity (details of the methods of the trial that produce reliable results, primarily the method of random sequence generation, concealment of allocation, blinding of participants and investigators, and inclusion of all participants results) of trials right from the design, through conduct and reporting; conform to accepted ethical standards; and lead to reporting of all relevant results of all clinical trials in India and the region.