<p>Post-approval observational studies that rely on traditional data collection approaches may be burdensome for community oncology settings with limited research infrastructure. We conducted a prospective observational study using an EHR-integrated platform to evaluate its feasibility for streamlining data collection in community oncology. We were able to capture high-quality data on infusion-related reactions in patients with multiple myeloma receiving daratumumab. The EHR-integrated platform included centralized patient identification, automated EHR-to-electronic data capture system data transfer, and centralized abstraction services. Over 11 months, 82 patients enrolled at four US community oncology sites, with 30.5% identifying as Black or Hispanic. Across 4568 essential data points: missingness accounted for 0.59%, 91% of data points were eligible for automated transfer, median transfer time for structured data was 1.7 days, and query frequency was &lt;2% with a median resolution time of 5.1 days. This pilot study demonstrated that EHR-integrated platforms can be operationalized in community oncology settings with high data completeness and rapid, diverse enrollment, expanding access to clinical trials outside traditional research centers and producing more generalizable results.</p>

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Feasibility assessment of an EHR-integrated research platform for prospective data collection in community oncology practice

  • Majd T. Ghanim,
  • Daniel Sanchez,
  • Claire Dykas,
  • Fredrik Borgsten,
  • Abhishek Dabral,
  • Mariana Fernandez,
  • Laura Hester,
  • Maneet Kaur,
  • Lakshmikanth Katragadda,
  • Yichen Lu,
  • Amanda Rodriguez-Sullivan,
  • Melanie Rothschild,
  • Paul M. Salcuni,
  • Natalie Salituro,
  • Richard M. Zuniga,
  • Neal J. Meropol,
  • Ashita S. Batavia

摘要

Post-approval observational studies that rely on traditional data collection approaches may be burdensome for community oncology settings with limited research infrastructure. We conducted a prospective observational study using an EHR-integrated platform to evaluate its feasibility for streamlining data collection in community oncology. We were able to capture high-quality data on infusion-related reactions in patients with multiple myeloma receiving daratumumab. The EHR-integrated platform included centralized patient identification, automated EHR-to-electronic data capture system data transfer, and centralized abstraction services. Over 11 months, 82 patients enrolled at four US community oncology sites, with 30.5% identifying as Black or Hispanic. Across 4568 essential data points: missingness accounted for 0.59%, 91% of data points were eligible for automated transfer, median transfer time for structured data was 1.7 days, and query frequency was <2% with a median resolution time of 5.1 days. This pilot study demonstrated that EHR-integrated platforms can be operationalized in community oncology settings with high data completeness and rapid, diverse enrollment, expanding access to clinical trials outside traditional research centers and producing more generalizable results.