Focus Area: Training
Recent Indian rules directly link trial participant compensation for injury or death to causality assessment.
The Indian Society for Clinical Research (ISCR) has worked in collaboration with the MRCT Center of Brigham and Women’s Hospital and Harvard to expand upon the WHO – UMC system and develop a comprehensive framework for clinical trials case causality assessment that will be relevant globally and within the Indian regulatory context for compensation. A need was identified for guidance documents and training materials to enable clinicians and ethics committee members to follow best practice procedures in determining causality for participant injuries or illnesses occurring in the course of a clinical trial.
Current status: dissemination and training in progress
Improved accuracy and uniformity in causality determination for clinical trials
- Review current best practices for causality determination
- Complete guidance document, case studies and training modules
- Disseminate materials
- Conduct trainings
- April 2014 – The MRCT Center partnered with the Indian Society for Clinical Research to establish a Causality Workgroup. The co-chairs of the workgroup are Usharani Pingali of the Nizam’s Institute of Medical Sciences and Shoibal Mukherjee of Quintiles. Other integral members of workgroup include Anirban Roy Chowdhury of Merck, Ritika Bajaj of Biogen, and Veena Jaguste of Amgen.
- October 2014 – Training modules and practical scenarios produced to ensure investigators and other experts tasked with adjudicating causality are up-to-date on the latest methods in causality determination and have practical scenarios to refer to in their work.
- November 2014 – First investigator training workshop hosted by Biogen and conducted by MRCT Center and ISCR in Gurgeon, India. Training covered:
– Background of causality determination
– Important definitions
– Distinction between cause & correlation
– Steps Involved in ADR diagnosis
– Causality Assessment by different stakeholders
– Common methodologies to assess causality
– WHO-UMC system
– Case studies
- February 2015 – Second investigator training workshop, co-hosted by the Indian Society of Clinical Research in Delhi.
- November 2015 – Training workshop in South Africa