In order to discuss the role and relevance of clinical research in meeting the needs of patients in India, Indian Society for Clinical Research (ISCR) is going to organise its 9th annual conference on the theme 'Clinical Research in India: Patients First and Research for India' in Mumbai between January 8 and 9. Around 400 clinical research professionals from India and overseas are expected to attend the event.
Over the last few years, clinical research in India went through a very turbulent period. Hard-hitting revisions in compensation guidelines in January, 2013 negatively impacted the growth of clinical research in India before more rational guidelines in 2015 restored some balance in the regulatory environment.
The forthcoming 9th annual conference will cover a vast range of topics of relevance and contemporariness from the perspective of clinical operations, investigator initiated research, accreditation, ethics, training, regulation, pharmacovigilance, medical writing, data management, statistics and career development in clinical research. It will be preceded by a series of pre-conference workshops for clinical researchers and students on accreditation, medical writing, risk-based monitoring and causality assessment.
Says Suneela Thatte, president, ISCR, "Clinical research is essential not just for developing medicines for emerging health concerns such as antibiotic resistant pathogens, H1N1 and dengue but also for finding safer and better medicines for endemic diseases such as malaria and tuberculosis and lifestyle diseases. A patient-centric approach guided by doing research in therapeutic areas with a focus on safety, ethics and quality is the underlying message expressed in the theme Patients First. The 9th annual conference presents a wonderful opportunity for all stakeholders involved in the conduct of clinical research in India to discuss and deliberate on how we move forward in a new regulatory environment."
Although home to a sixth of the world’s population, less than 1.4 per cent of global clinical trials is done in India, a country which also has a fifth of the global disease burden. More needs to be done. There is no greater evidence of India’s research strength than in the most recent development of the rotavirus vaccine which was a major research breakthrough given that India loses close to 2 lakh children to diarrhoea every year, of which 1 lakh deaths are caused by the rotavirus1.
Dr. Suresh Menon, member, Executive Committee and Regulatory Council, ISCR says, “Clinical research should not be looked at in isolation of the larger healthcare needs and priorities of our country. We have a great task ahead of us in working together to strengthen clinical research sites, investigators and ethics committees and of course, empowering the patient who is at the centre of clinical research. At the same time, we have a responsibility in working with each other to help restore trust and confidence of global stakeholders in doing clinical research in India. This is an important and immediate requirement.”
Across the country, large medical institutions are also investing in research to meet the specific needs of our population and these efforts need to be encouraged. Patients First and Research in India will result in better, faster and more affordable and accessible treatment for patients in the country.
Dr. Girish Chinnaswamy, Associate Professor, Dept. of Paediatric Oncology, Tata Memorial Hospital opines, “As medical practitioners and investigators, we have an important responsibility to ensure that patients have access to the latest and best treatment options. Vulnerable populations, whether children or mentally ill, have equal rights to participate in and benefit from clinical trials. There are stringent safeguards in place to protect such groups and we cannot deny them the opportunity to participate in a trial. In the long run, we need to empower patients so they have more control in decisions governing their health even if it means their participation in a clinical trial.”
Core to this is the need to create greater education and awareness of clinical research and its relevance to India, as also on the rights and responsibilities of patients participating in clinical research. Through NavChetana, an advocacy initiative launched in early 2015, ISCR has been holding awareness sessions on clinical research at various medical and public fora and this will continue in 2016.
Dr. C. S. Pramesh, Professor and Chief, Thoracic Surgery, Dept. of Surgical Oncology, Tata Memorial Hospital says, “In the last one year, we have seen steps taken by the regulators to address many of the contentious guidelines and hope that the process of reform will continue in 2016 so that ultimately patients will benefit.”
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.