Healthcare research has faced severe disruption during the COVID-19 public health emergency and underscored the need for novel technological solutions that harness and utilize data beyond traditional clinical research models. From real-world evidence (RWE) and real-world data (RWD) to registries, predictive analytics and virtual clinical trials, solutions that combine data, powerful computing and novel data collection methods can present healthcare innovators, researchers and drug and device developers with robust, actionable insights to transform care and develop cutting-edge products and therapeutics.
Join McDermott Will & Emery and leaders from Aetion and CancerLinQ, a non-profit subsidiary of the American Society of Clinical Oncology (ASCO), for a discussion of the legal and operational considerations of RWE, RWD and other data-powered solutions, including:
- How can care providers and researchers optimally collect new data and evidence through virtual means and in ways that maximize utility for generating regulatory-grade RWE and other applications downstream?
- How can researchers and providers collaborate with technology companies to leverage RWE and RWD for regulatory decision-making?
- What are the Food and Drug Administration regulatory considerations, privacy considerations and use cases under different privacy pathways presented by large-scale data collection and digital data use?
- How can old and new stakeholders contribute to the digital data paradigm and tap into unrepresented groups and other sources of data?
- What is the pandemic’s short- and long-term impact on the demand for alternative sources of data and what challenges exist to procuring these data sources?
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