New Delhi: After a bypass, an angioplasty, 10 hospitals, 13 times angiogram and a 3 year Ramdeo rendezvous, 59 year old heart patient diabetic Mandeep Singh (name changed) lost all hope.
But a chance tryst with clinical trial as subject that began a year ago proved a boon for him. He is part of a global research in which Medanta, the Medicity associates. The outcomes of the anonymous drug on other subjects, including that on Mandeep, so far have indicated that a magical medicine for cardiac patients may be in the offing, though it might take 3 years to be launched as a life saving drug.
ISCR showcased this patient in its two day annual conference starting on February 15 to stress the point that the slur on clinical professionals that they treat participating patients as Guinea Pig is ill founded. Dr Chirag Trivedi, President, Indian Society for Clinical Research (ISCR) in a press conference on the sidelines of conference said the Guinea Pig is a misnomer and sought media support for wiping out the slur. Independent studies and audits have confirmed the high quality of clinical research being done in India, he added.
Through Mandeep Singh, Dr Trivedi also stressed how well he was treated as subject of the clinical trial which proved a game changer for him in the midst of hopelessness. Mandeep told media that while he despaired, Dr Naresh Trehan, Managing Director, Medanta and a globally renowned heart surgeon, wanted to know if he was interested in joining the clinical trial that might prove efficacious. He readily joined the trial. And lo and behold! He met medicine of a life time!
Mandeep said, ‘my entire arduous odyssey started with a heart attack in 2002. I tried all mainstream cardiac options available but of no avail. I am fortunate enough that I got the opportunity of being included in the clinical trial. I would not be able to even walk a few steps. But after joining clinical trial and taking the medicine, my condition has greatly improved. Now, I daily walk about six kilometres.’
Mandeep was all praise for trial professionals who would keep close and regular watch on him and they were instrumental in bringing about a complete change in his life style. The clinical trial turned him really a new leaf.
In the two day brain storming conference, the focus of concern was abysmally low output of clinical trials in India while diseases burden far outweighs it.
‘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,” said Dr Chirag Trivedi, President, Indian Society for Clinical Research (ISCR) speaking at the commencement of the 12th Annual ISCR Conference being held in Delhi.
“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 for participating patients, but also for society at large ‘he added.
Recent data from www.clinicaltrials.gov indicates that the number of clinical trials being done in India as a percentage of global trials continues to fall. From 1.5% a couple of years ago, the percentage of clinical trials in India is now 1.2% which is inadequate for a country that has the second highest population and the highest disease burden in the world.
It is against this background that ISCR held its Conference on the theme Clinical Research Advancing the Frontiers of Health. The Conference, attended by 500+ clinical research professionals, focussed on various clinical trial reforms that will build the future research enterprise as well as on emerging research opportunities in India.
‘Clinical research in India is governed by robust local and global regulations which make 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 bio pharma companies from doing more research in India,” said Dr Sanjay Mittal, Senior Director – Clinical Cardiology & Head of Research, Medanta – The Medicity. He further said, ‘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, benefit our practice and patients.’
Through two days of panel discussions, the ISCR Annual Conference examined and discussed varied perspectives about clinical research from patients, investigators, regulators and academia. Emerging trends in clinical research, as also career opportunities in clinical research was discussed during the panels. Parallel to the main track, a separate track focused on Data Management, Medical Writing and Biostatistics’.
Dr Trivedi said that it was imperative that more is done to highlight the robust regulatory environment in India to stakeholders across the world so as to encourage more investment in clinical research in India. A conducive clinical research ecosystem will encourage more research and development and will give an impetus to the Government of India’s ‘Make in India’ initiative. “We are as committed to the DCGI’s commitment to making safe, efficacious, affordable and quality medicinal products for our people. If we can have a Make in India for other goods and services, why cannot we have a Make in India for clinical research too?” concluded Dr Trivedi.
Given the larger context of India’s unique healthcare requirements and the growing incidence of endemic diseases and emerging lifestyle diseases, more clinical research is needed to develop new and effective medicines and vaccines to tackle the country’s mammoth disease burden and unmet medical needs. India has 18% of the world’s population and 20% of the global disease burden and yet, 1.2% of global trials take place in India.
The Indian Society for Clinical Research (ISCR) is an association of clinical research professionals that aims to build awareness of clinical research as a specialty in India and to facilitate its growth in the country while helping to evolve the highest standards of quality and ethics.