After running the Clinical Trial Registry of India (CTRI) for over two years on a pilot basis in the country, the National Institute of Medical Statistics (NIMS) is upgrading the Registry for the smooth functioning and also to include more features to it. NIMS is an arm of Indian Council of Medical Research (ICMR) mandated with the responsibility of setting up and maintaining the National Clinical Trials Registry of India.
Several new features as per the requirements of the World Health Organisation (WHO) like audit trail (constant tracking of data) will be included in the new format. The software of the Registry will soon be upgraded to make it automatic, instead of manual checking of the quality parameters, said Dr Aahba Agarwal, coordinator at the NIMS.
As the registration of a clinical trial in the country was made mandatory by the DCGI, there has been a added momentum in the number of registration of clinical trials in the country. Dr Agarwal said that based on the experience in the pilot project, it was decided to implement a fresh well designed Web Hosted Clinical Trial Registry to meet the expectations of the various stakeholders including the pharmaceutical industry, researchers, publications, administrators and the public at large. Being a front runner, among the first ten across the world, in the implementation of the mandate of registration of clinical trials, the Clinical Trial Registry of India will be keenly monitored across the world.
Dr Agarwal said that a lot of new features have to be included in the existing Registry which was launched on July 20, 2007. Since the Indian Registry is getting applications from all over the world, it has to be on line with the international standards. In the present Registry, a lot of requirements of the WHO are missing. For example, there is no clause for audit trail in the present Registry without which the authorities will not be able to track the changes constantly in the data of the trial. As the companies very often make changes in the data, it is very necessary to include such a clause in the Registry, Dr Agarwal said.
She said that since the DCGI has made it mandatory to get all new clinical trials registered with the CTRI as a pre-requisite for obtaining permission for clinical trials in the country, there has been a substantial increase in the number of applications. So, the entire system is being upgraded to make it automatic, instead of manual checking of the quality parameters and other criteria.