A series of developments in the recent past relating to clinical research in the country has to a great extent helped bring balance in the regulatory environment. The compensation guidelines are rational and more predictable approval timelines are likely to take shape with the expansion of the Subject Expert Committees (SECs). These were some of the relevant points expressed at the 9th Annual Conference of the Indian Society for Clinical Research (ISCR) in Mumbai from 7 to 9 January, 2016.
Over 400 clinical research professionals from across the stakeholder spectrum were drawn together to discuss and deliberate on the theme ‘Clinical Research in India: Patients First and Research for India’ and what more needs to be done to create a more enabling environment for the conduct of clinical research in the country.
Said Suneela Thatte, president, ISCR on the sidelines of the occasion, “We now have a regulatory system that is balanced, aligned with global trends and innovation. This is a significant development, something that we at ISCR hope to build upon in 2016. It now extremely important not to lose sight of quality and compliance as the clinical research industry enters into the growth phase. The last three years were a difficult time for clinical research in India. The expected roll-out of the accreditation process is also projected to have a significant impact on the quality of research. What has been extremely encouraging is the inclusive approach adopted by the regulators whereby stakeholder feedback has been actively sought and acted upon in many cases.”
The conference began on a reflective note with a citation in memory of the late Prof. Ranjit Roy Chaudhury whose commitment to the progress of clinical research in India led the fraternity through its most challenging times and provided new hope of a regulatory environment built on scientific and rational principles. The citation was delivered by Prof. Y K Gupta, professor and head, department of pharmacology, AIIMS and executive committee member, ISCR.
Dr. K L Sharma, joint secretary, ministry of health and family welfare stated “The government of India understands the importance of clinical research in India and the industry concerns have been addressed substantially. In areas where we need improvement, the government is willing to engage with industry stakeholders and academic and research institutions to work out solutions. We are committed to leverage the resources in the public and private sector to ensure cutting edge research in drug related areas.”
“Evidence-based medicine has made the single biggest contribution to the practice of medicine in the last fifty years and this has only been possible because of well conducted trials,” said Prof. Anil K D’Cruz, chief, department of head and neck surgery, Tata Memorial Hospital, while delivering an address on 'Clinical Research to Improve Patient Care – Trials, Tribulations and Success'. He drew from several clinical trial case studies to demonstrate the value of clinical research to patients and also highlighted how hospitals that invest in clinical trials provide better hospital care. He also stressed on the need for more investigator initiated research to be encouraged for diseases and illnesses that impact Indian populations to ensure better outcomes.
The conference sessions touched upon topics such as clinical research operations, investigator initiated research, accreditation and understanding the functioning of US FDA advisory committee meetings as also on how technology is redefining the conduct of clinical trials and the use of electronics for the recording and management of health data.
The Industry-Academia Leader’s Conclave, which had representation from the heads of industry and hospitals in the country discussed the impact of the last few years on clinical research in India and what needs to be done to bring clinical research in India back on track to meet the increasing burden of disease in the country. Said Dr. Rajendra Badwe, director, Tata Memorial Hospital, “We need to ensure a permissive regulatory environment that is patient-centric. Improving patient outcomes is our first and foremost objective and we all collectively work towards ensuring that patients have access to latest therapeutic options for their unmet medical needs. In India, the perception that patients are being used as guinea pigs needs to change.”
“Our patients cannot be disadvantaged and need to get drugs at the earliest. In addition, we need a scientific temperament to be built in our country and an environment and enabling policy that will foster research,” said K G Ananthakrishnan, managing director, MSD India. Agreeing on the need to highlight the contribution of science to society, Sharad Tyagi, managing director, Boehringer Ingelheim said that some fundamental issues like science and its perceived exploitation still need to be addressed and perceptions about science need to change in our country.
“The challenges of the last few years have provided the industry an opportunity to change and innovate in a new regulatory environment. It also brought all stakeholders together on a common platform for the first time which augured well for the industry,” said Naz Haji, senior vice president, Quintiles Research India.
Panelists agreed that building trust and confidence in global stakeholders was an important requirement in bringing trials back to India while also highlighting that investigator and patient testimonials about the benefits of clinical research was also important in creating widespread awareness about the contribution of clinical research to better healthcare and patient outcomes. “We reiterate our commitment to continue our engagement with all of you and work towards creation of a clinical research ecosystem that balances the interests of all stakeholders – particularly the patients,” Thatte concluded.