Causality assessment: A casualty of compensation?

Causality assessment: A casualty of compensation?

Blog Article

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 K-PAK RECONSTRUCT CONDITONER 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 Tin Sign 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.