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The ENCORE project emulates 12 oncology trials using real-world data from electronic health records. This research evaluates how real-world evidence (RWE) can reliably inform cancer treatment effectiveness and safety, complementing traditional trial findings.

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Area of Science:

  • Oncology
  • Real-world evidence research
  • Clinical trial emulation

Background:

  • Real-world evidence (RWE) complements randomized controlled trials (RCTs) by assessing medical interventions in routine practice.
  • Electronic health record (EHR) data enables RWE studies in oncology, where claims data is insufficient.
  • Previous DUPLICATE initiative work established methods for emulating trials with RWE for non-oncology indications.

Purpose of the Study:

  • To extend trial emulation methods to oncology using real-world data (RWD).
  • To design and select trials for the Emulation of Comparative Oncology Trials with Real-world Evidence (ENCORE) project.
  • To assess the fitness of EHR data for emulating oncology RCTs and drawing causal conclusions.

Main Methods:

  • Emulation of 12 comparative oncology RCTs across four cancer types (non-small-cell lung cancer, breast cancer, colorectal cancer, multiple myeloma).
  • Utilizing four oncology-specialized EHR databases.
  • Systematic evaluation of data fitness, study design, and statistical analysis.
  • Preregistration of study protocols.
  • Assessment of agreement between RCT and emulated trial treatment effect estimates.
  • Extensive sensitivity analyses benchmarked against RCT results.

Main Results:

  • The ENCORE project is designed to emulate 12 RCTs in four oncology indications using specialized EHR databases.
  • Emphasis on systematic data fitness evaluation and protocol preregistration.
  • Prespecified criteria will assess agreement between RCTs and their emulated counterparts.
  • Sensitivity analyses will benchmark RWD findings against RCT results.

Conclusions:

  • The ENCORE project aims to enhance understanding of RWE in oncology trial emulation.
  • It will inform decisions regarding measurement, design, and analysis for RWD studies.
  • The findings will guide the interpretation of results from emulated oncology trials using EHR data.