Keywords: real world data, real world evidence
Various sources of real world data could be leveraged in the clinical studies in the regulatory settings. Such data may reflect real world clinical practice and could potentially be used to reduce the cost of the traditional clinical trials. However, challenges arise regarding how to transform the real world data into valid scientific evidence that can be used in the regulatory decision making for premarketing approval of medical device products. This talk will present some examples and discuss some considerations and challenges from the statistical and regulatory perspectives.