All Times EDT
Keywords: RWD, RWE, EHR
Single arm trials in oncology encounter the some of the same challenges and biases encountered in observational data in terms of selection and confounding biases in the absence of a randomized control arm. The 21st Century Cures Act (Cures Act) encouraged the use of Real-World Data (RWD) and Real-World Evidence (RWE) in facilitating regulatory decision-making. Since then, there has been an interest in using RWD for the purposes of an external comparator so that decisions on comparative effectiveness and safety could be made. This presentation will outline the benefits and challenges associated with the use of RWD to construct ECAs both in the context of a single arm and RCT design. Different aspects that need to be considered when selecting a fit for purpose database in terms of relevance, reliability, completeness, and applicability to the target patient population will be presented in the context of electronic health records (EHR). Some considerations for statistical analysis to account for confounding biases will be presented. We will also look at some used case examples of EHR data submitted to the regulatory agencies and disseminate the feedback received.