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Abstract:
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With the growing need to enhance the efficiency of the current drug development process, regulators and pharmaceutical companies have increasingly turned their attentions to non-traditional and novel approaches and data sources. Thanks in part to the unfolding advances in predictive analytics and computing platforms, there is a renewed interest in the use of real-world evidence to complement data from randomized controlled trials. However, effective use of such data requires addressing important operational, conceptual and regulatory challenges. We elucidate pertinent aspects of the use of real world evidence in regulatory settings, with emphasis on study design, analytical strategies, data quality and regulatory requirements.
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