Comparative Effectiveness Research

Comparative Effectiveness Research

China: Key Considerations in Using Real-World Evidence to Support Drug Development – A research method, by considering both individuals and the population in an environment as close as possible to the real world, that evaluates the clinical effectiveness and safety, social effects, and economic benefits of a particular intervention. Such evaluation helps key stakeholders such as patients, doctors, policy makers, and service consumers to improve healthcare services so that the most appropriate interventions or strategies can achieve the optimal outcomes in the most appropriate target population and timing (as per Key Considerations in Using Real-World Evidence to Support Drug Development (Draft for Public Review) – Center for Drug Evaluation, NMPA – May, 2019).

The comparative effectiveness research is based on the real world, with a wide range of applications focusing on the decision-making for the natural population. Therefore, it is necessary to consider the impact of many factors on the outcome as comprehensively as possible. The designs are often more complex with usually a large sample size. In the meanwhile, there are clear requirements for valid statistical analysis in terms of causal inference (as per Key Considerations in Using Real-World Evidence to Support Drug Development (Draft for Public Review) – Center for Drug Evaluation, NMPA – May, 2019).