The Clinical Trials Registry-India (CTRI) set up by the Indian Council of Medical Research may register all ongoing clinical trials along with prospective trials in it, it learnt. The Registry has been set up just two months ago and is well received in the industry.
After the CTRI was launched on July 20 by the National Institute of Medical Statistics NIMS, an initiative of ICMR, 12 prospective trials have been registered so far and the NIMS has been receiving a lot more enquiries.
``The response is good. We have already 100 registered users, mainly pharmaceutical companies. So far only the prospective trials, cleared by the Ethics Committee, are allowed to register. Now we will extend the spectrum to cover the ongoing trials too,'' its coordinator Dr Abha Rani Agarwal said.
The mission of the CTRI is to encourage all clinical trials conducted in India to be prospectively registered before the enrolment of the first participant and to disclose details of the 20 mandatory items of the WHO International Clinical Trials Registry Platform (ICTRP) dataset. In this manner the CTRI hopes to become a WHO ICTRP ICMJE (International Council of Medical Journal Editors) compliant Primary Register for India.
It is aimed at giving all required information about a trial at a single point to the public and researchers and make trials more transparent. It also would help stop the practice of suppressing negative results of trials by companies.
A similar registry was also launched around the same time by China, the main competitor of India in the fast growing clinical trials sector. The online registry showed that it also could rope in only a dozen registrations so far.
With the ongoing trials also being included, the authorities are hoping to see a big rush of registrations and greater service for the users. The NIMS has been getting positive responses across the country after the registry was launched. They said that many features of the registry were still under development and it would be soon transformed into fully operational platform with an array of services.
According to available reports, nearly 300 clinical trials are going on in the country whereas just 120 trials were held last year. Clinical trials in India cost 50 per cent less than the average cost in the US and recruitment of patients were said to be far easier, prompting the multinationals to shift focus to India.
CTRI puts the data of on-going clinical trials in public domain, an attempt to make the clinical research more transparent and accountable in a time when India is increasingly emerging as a preferred destination for outsourcing of clinical trials. At the same time, the clinical trials arena has been one of the least regulated sector notwithstanding some guidelines in existence. The Centre is also in process of putting a policy in place for the sector.
The WHO has been encouraging the countries to create platforms for registration of all trials involving humans at the early stage of development. The International Committee of Medical Journal Editors in July 2005 made mandatory the registration of trials for publication of findings and reports in 12 leading medical journals worldwide. This triggered a sudden spurt in registration. The US Government registry receives 200 entries every week now.