“Creating a more conducive environment will go a long way in encouraging more clinical research”
Dr Chirag Trivedi
President, Indian Society for Clinical Research (ISCR)
Indian Society for Clinical Research (ISCR), an association of clinical research professionals, aims to build awareness of clinical research as a specialty in India and to facilitate its growth while helping to evolve the highest standards of quality and ethics. In an interaction with Aishwarya Venkatesh of BioSpectrum, Dr Chirag Trivedi, President, ISCR shared his thoughts about the issues before the industry and means of overcoming these challenges.
What are major issues before the industry?
The last few years have been a transformative one for clinical research in India. Important regulatory changes have led to a more supportive environment for conducting research. The number of global clinical trials is slowly picking up and it will take a year or two before we see a significant increase. Overall, there has been a positive shift in people's attitudes and perceptions about clinical trials but, given the huge disease burden India carries, a lot remains to be done.
Part of this is because there is a still lack of awareness globally about all the regulatory changes that have taken place in the last few years and part of it is because sponsors are waiting for the environment to settle down further.
There are still a few areas that need to be addressed:
There is a need for better clarity on the accreditation process of Ethics Committees that is intended to take effect from January 1, 2018.
While the approval process was streamlined further recently, approval timelines are still around five months and we need them to come down further.
Due to the regulatory challenges of 2013, many investigators have stopped conducting clinical trials. Hence, there is some amount of work that needs to be done for the Physician community and Ethics Committees so that we can have a good number of them conducting quality clinical trials in future given the fact that the regulations have become more balanced and predictable and at the same time, are protective of the rights, safety and wellbeing of trial participants. Regulators too can play a significant role in building confidence amongst various stakeholders.
Finally we need to raise more awareness about the high quality of clinical research that is being done in India and the good that it has done for our Indian patients.
In the larger context of India’s unique healthcare requirements and the growing incidence of endemic diseases and emerging lifestyle diseases, we need clinical research to develop new and effective medicines and vaccines to tackle our mammoth disease burden and unmet medical needs. India has 17 per cent of the world’s population and 20 perc ent of the global disease burden and yet, less than 1.4 per cent of global trials take place in India.
What needs to be done to overcome these issues?
I do believe that more awareness around the regulatory changes, the high quality of clinical research being done in India, our growing burden of disease and patient population and reiteration by the regulators to creating a more conducive clinical research environment will go a long way in encouraging more clinical research in India.
Can India bounce back as clinical research hub in the coming years?
I think the word ‘hub’ is a misnomer. India was never a hub for clinical research and it really does not matter whether it is or not. What matters is that the quantum of clinical research being done in our country should be proportionate to our disease burden. Clearly it is not at the moment and the ones most impacted by this are patients. We have a huge task on hand of fighting the unmet medical needs of Indian patients.