The new clinical trial rules are expected to be published in March, which is set to change the scenario of clinical research trials in India, informed experts
The 12th Indian Society for Clinical Research (ISCR) 2019 annual conference was recently held in New Delhi on the theme ‘clinical research advancing the frontiers of health.’ The event saw participation from more than 500 clinical research professionals who focussed on various clinical trial reforms that will build the future research enterprise as well as on emerging research opportunities in India.
The summit began by paying tribute to the CRPF martyrs who recently lost their lives in a terror attack in Pulwama, Kashmir. Thereafter, following a lamp-lightning ceremony, Dr Chirag Trivedi, President, ISCR, addressed the august audience. He informed that since its inception in 2005, ISCR has become a ‘go to body’ for many clinical researchers. He added, “The changing profile of diseases affecting the Indian population, the continuing high prevalence of endemic diseases and the emergence of lifestyle diseases all point to an urgent need for greater investment in research and innovation to address India’s increasing disease burden and the incremental costs associated with it.”
He also emphasised that stakeholders need to work together to build and strengthen the clinical research ecosystem in the country and create an environment that encourages more research. At the same time, there is a need for more education and awareness about clinical research and its benefits not just to participating patients, but also to society at large.
Express Pharma and Express Healthcare were the official media partners for this annual conference.
During the inaugural session, S Eswara Reddy, Drug Controller General of India, DCG(I), Central Drugs Standard Control Organization (CDSCO), said, “India has huge potential for ethical and scientific clinical research given our large patient population, state-of-the-art hospitals, skilled investigators and strong patient groups.”
He, however, expressed his disappointment over the clinical trails not being promoted properly. “There hasn’t been any consistency in the procedures and practices for getting approval to publish a clinical trial,” he said, while also raising concern on fake medical trial reports.The government has realised the problems associated with the system and to make the regulator more accessible, we have now opened our PR office at CDSCO. One can visit even without any prior appointment,” he informed.
“Earlier, there were legal issues due to which clinical trials could not be published. However, now, there is no restriction on the work to be published on clinical trials. Thanks to Parliament Standing Committee and the Supreme Court for intervening and giving various directions on strengthening of clinical trials in India,” he said.
Reddy informed that in the first week of March, we will publish a new set of clinical trial rules. “This, I assure you, is going to change the entire scenario of clinical trail research in India. The maximum time to review the process, the application and opinion is just 30 days now. These are also being translated into Hindi and are expected to be published in the first week of March, he added.
Besides, he touched upon the theme of artificial intelligence saying, “As a drug regulator, we should try to understand how we can use the best software for clinical research in India.”
Recent data from www.clinicaltrials.gov indicate that the number of clinical trials being done in India as a percentage of global trials continues to fall. From 1.5 per cent a couple of years ago, the percentage of clinical trials in India is now 1.2 per cent, which is inadequate for a country that has the second highest population and the highest disease burden in the world.
“Clinical research in India is governed by robust local and global regulations which makes India amongst the most stringent clinical research regulatory environments in the world. In such an environment, we need to encourage, not deter, not-for-profit organisations, institutions and biopharma companies from doing more research in India,” said Dr Sanjay Mittal, Senior Director – Clinical Cardiology & Head of Research, Medanta – The Medicity. “The most impacted by the current environment are patients who will not have access to the latest and most effective treatment for various medical conditions. For us investigators too, participating in clinical research exposes us to the latest trends and treatment protocols, which, in turn, benefits our practice and patients,” he added.
A clinical trial patient at the media briefing shared his experience of participating in a clinical trial and the rigour of the process, while highlighting how the trial benefited his condition.
At the conference, Suneela Thatte from IQVIA, who has also been President, ISCR (2013-2017), received the ISCR Lifetime Achievement award for her commitment to clinical research advocacy, policy shaping, education and leadership in India.
Apart from it, a Clinical Research Certification Programme comprising three modules was also launched at the event for clinical research coordinators.