Focus Area: Capacity Building
Assignment of causality of adverse drug reactions during a clinical trial is performed routinely to determine the relationship of a safety event to use of an investigational product. Safety assessments of an investigational product depend upon understanding of causality and the differentiation from correlation or association. Fair compensation for injury occurring during a clinical trial is predicated on an accurate causality assessment and determination of whether the injury or death is related to participation in the trial and a consequence of the investigational product.
Recent Indian rules directly link trial participant compensation for injury or death to causality assessment. 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. The Indian Society for Clinical Research (ISCR) has collaborated with the MRCT Center to expand upon the WHO-UMC system and to develop a comprehensive framework for clinical trials case causality assessment. The causality training will not only be relevant within the Indian regulatory context for compensation but can also be used globally.
Current status: Dissemination
Impact: Improved accuracy and uniformity in causality determination for clinical trials
- Review current best practices for causality determination
- Develop Causality Tool
- 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 (Nizam’s Institute of Medical Sciences) and Shoibal Mukherjee (Quintiles). Other integral members of workgroup include Anirban Roy Chowdhury (Merck), Ritika Bajaj (Biogen), and Veena Jaguste (Amgen).
- October 2014: Developed training modules and practical scenarios to ensure investigators and other experts tasked with adjudicating causality understand methodology used in causality determination and have experience with practical examples of case studies.
- 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
Project Lead: Barbara Bierer