title: Causality assessment: A casualty of compensation?
abstract: Recent Indian rule on compensation for any injury or death of the subject in a clinical trial, has generated a lot of discussion on its impact on clinical trials in India. The legal process in the compensation rule is based on the causality assessment. However, it ignores the scientific basis of causality assessment. This could have far reaching consequences on (1) science of causality assessment and (2) safety assessment of a new drug under clinical development. There is a need to bring clarity on causality assessment process within the compensation rules to balance the ethical need of human subject protection and the scientific requirements of safety assessment.
authors: Clininvent Research Pvt. Ltd, Marol Naka, Andheri (East), Mumbai, Maharashtra, India.
authors: Anuradha
authors: A
authors: Kulkarni
authors: Arun
authors: A
authors: Bhatt
keywords: Causality; clinical trial; compensation; investigational product