ISCR Launches Causality Assessment Portal At Its 10th Annual Conference

Indian Society for Clinical Research (ISCR) concluded its 10th Annual Clinical Research Conference in Mumbai on Saturday.

Speaking on the sidelines of the conference said, Suneela Thatte, President, ISCR, “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 a reality for drug development and clinical research in India.” “Regulatory capacity building and creation of public awareness balanced with ethics are must for making this a reality,” she added.

Shoibal Mukherjee, founder president and an active member of ISCR, felt that science is not clearly defined in the country and urged the government to create an “atmosphere to do research at ease.” Mukherjee also felt that over activism is another road block for conducting clinical research in the country.

Launched during the conference was a Causality Assessment Portal developed by ISCR in collaboration with MRCT Harvard. 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.

The action packed two-day conference witnessed various sessions on: Industry – Academia Conclave, Impact of recent changes to regulations for clinical research, Technology innovations and applications to healthcare, Research in rare diseases, Investigator initiated research, ‘Does India feature in discussions on global clinical study,’ among others. Professionals from its 3 Chapters – North, West and South attended the two-day 10th Annual Conference in large numbers.

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.