A causality assessment portal developed by Indian Society for Clinical Research (ISCR) in collaboration with MRCT Harvard was launched at ISCR’s 10th annual clinical research conference that was inaugurated in Mumbai recently.
The portal aims to develop a comprehensive framework for clinical trials case causality assessment that will be relevant globally and within the Indian regulatory context for compensation.
This becomes particularly significant in light of the recent Indian regulations that directly link trial participant compensation for injury or death to causality assessment. The portal will serve as a tool that provides guidance documents and training materials to enable clinicians and ethics committee members to follow best practice procedures in determining causality for adverse events in a clinical trial.
“Clinical research professionals need to take a more proactive role in conducting research in India. A more conducive regulatory framework for the conduct of clinical research will enable this and encourage local innovation, ensuring that Make in India is a reality for drug development and clinical research in India. This will help make our theme Patients First and Research for India a reality,” said Suneela Thatte, President, Indian Society for Clinical Research (ISCR), at its 10th annual clinical research conference that was inaugurated in Mumbai today.
An engaging panel discussion on ‘Regulations for Clinical Research – has it led to better protection of patient safety?’, saw lively views from various stakeholders. Dr. V G Somani, Joint Drugs Controller reiterated Government of India’s commitment to making India a favoured destination for clinical research. “We are going through a transition phase where we are focused on bringing about several improvements in the clinical research regulatory environment for the benefit of patients and the society at large,” he said.
Delivering the Prof. Ranjit Roy Chaudhury oration on TB: challenges and solutions for the 21st century, Dr. Soumya Swaminathan, director general, ICMR said, “It gives me great pleasure to note the many positive changes in the clinical research environment these past few years in India. ISCR has been working relentlessly in this direction. We must continue to invest in capacity building of subject experts, sensitize leadership at the political level, work with ethics committees who are increasingly responsible for patient safety, and encourage patient representation at various fora.” She spoke of the growing incidence of tuberculosis in India and the need to address social, environmental, behavioural and economic risk factors for tuberculosis. She also spoke of the TB Research Consortium set up by ICMR and said there is an opportunity to develop medicines in India for the world.
ISCR presented the Academia Award for notable contribution to the clinical research fraternity to Tata Memorial Hospital and the industry award for notable contribution to the Clinical Research Fraternity to Dr. Arun Bhatt who has over thirty years of clinical research experience.
A panel discussion witnessed leading industry experts and academia who spoke of the need for improving stakeholder trust in clinical research, creating a more conducive environment for clinical research and further improvement in regulations. They highlighted the need for more investigator and patient testimonials on the benefits of clinical research, and its role in ensuring better health and patient outcomes. “Clinical research drives innovation and it is incumbent on us to do more clinical research to contribute to more drug development in India,” said Naz Haji, SVP & MD, R&D solutions, QuintilesIMS India.
A parallel track was held on data management, medical writing and biostatistics which focused on e-technology advances in clinical operations, oncology trials and NCEs in India. Attending the conference were clinical research professionals from across the stakeholder spectrum. With India operating in a new regulatory environment, Thatte stressed on the key responsibility of each clinical research professional to renew their pledge to quality, patient safety and data integrity and set an example to the rest of the world as to how quality and ethics are not mere tokenism but truly reflect the spirit of the clinical research community in India.
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.