印度药物临床试验损害赔偿机制及其对中国相关制度制定的启示OA

With the improvement of China's scientific research capabilities,the number of innovative drug enterprises and clinical trials has increased,and disputes over damage compensation have also risen accordingly.It has become a consensus to resolve such disputes through institutionalization.Given the similarities between China and India in terms of population and development level,this study analyzed India's compensation mechanism for clinical trial damage,including the definition of damage,compensation procedures,and calculation methods.Through a comparison of the mechanisms between China and India,this paper put forward suggestions for improving China's compensation mechanism for clinical trial damage,that is,clarifying the compensation process for clinical trial damage,the scope and calculation methods of damage compensation,and the compensation ratio corresponding to the correlation between damage and clinical trials.It also proposed to use disability weights to measure the participants'health status before their enrollment in clinical trials,and to calculate the amount of compensation for disability and death based on their health status.