Aetion CARE Initiative

The Coalition for the Advancement of RWE through RCT Emulation

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Understanding the strengths and limitations of regulatory-grade RWE

A first-of-its-kind cross-industry initiative, CARE brings together leaders in healthcare to facilitate multiple trial emulations using various data sources to understand where real-world evidence is appropriate and where it is not, beginning with a focus on oncology.

Advances in data quality, accessibility, and analyses are occurring at a rapid pace. It is critical that users of data work in concert to optimize the use of RWE to improve patient access and positively impact the healthcare industry.

This initiative will provide a detailed understanding of when and why RWE may give different information than an RCT, building a contextualized understanding of strengths and weaknesses in emulating trials in an oncology setting.

In what context can well-designed emulated RCTs, built from the highest-quality RWE, replicate the findings from pivotal RCTs in which a product was approved for a new indication in oncology?

And where is it not appropriate, either due to data quality, missingness, bias or confounding, or other reasons?

Together with our partners, we are seeking to answer these questions and set a new precedent for the use of RWE to complement RCTs to better inform regulatory decision-making. The findings from CARE will be published in a series of peer-reviewed publications to ensure transparency and the greatest impact on the field.

Interested in joining the CARE Initiative?

Connect with the CARE team to learn more about how your organization can contribute to this cross-industry initiative.