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Monday, June 24 • 2:15pm - 3:15pm
#140: Use of Real World Data in Clinical Trials: Abstracting Endpoints from Encounters

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Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-19-540-L04-P; CME 1.00; IACET 1.00; RN 1.00

Standardizing real world data, consisting of EHR and claims encounters, into a clinical trial endpoint relies on a complex process of selecting the appropriate data-set and filtering, mapping and merging healthcare encounters from EHR to trial endpoints.This session will describe and appraise approaches and challenges in formulating the endpoints, in both prospective and retrospective research projects, with a focus on cardiovascular endpoints as well as demographic data.

Learning Objectives

Describe process to extract clinical trial endpoints from EHR and claims datasets; Identify how to apply a process to supplement objective EHR and claims dataset endpoints with correlated patient-reported outcomes.


Debra Fasteson Harris


Phenotypic Diagnosis of Rare or Difficult to Diagnose Diseases
Richard Gliklich, MD

PRO Perspective not Typically Available in EHR or Other Large Existing Real World Datasets
Amanda Harrington

avatar for Richard Gliklich

Richard Gliklich

Chief Executive Officer, OM1
Dr. Richard Gliklich is the CEO of OM1, Inc., an outcomes and technology company focused on real world evidence and measuring and predicting outcomes. Previously, he was founder and CEO of Outcome, which he led from inception through its acquisition by Quintiles. A graduate of Yale... Read More →
avatar for Debra Harris

Debra Harris

Associate Director (Operations), Pragmatic Health Systems Research (PHSR), Duke Clinical Research Institute
Debra Harris is the Associate Director of the Center for Pragmatic Health Systems Research at the Duke Clinical Research Institute where she focuses on the use of real-world data for clinical research. She is clinical trial-ist with more than 20 years of data management, cardiovascular... Read More →

Amanda Harrington

Lead Clinical Trial Coordinator, Duke Clinical Reserach Institute

Monday June 24, 2019 2:15pm - 3:15pm PDT
Room 1AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  03: Data-Data Standards, Session
  • Level Beginner
  • Featured Topics What's Next
  • Featured Topics Real World Evidence,Innovative Trial Design,What's Next
  • Credit Type ACPE, CME, IACET, RN
  • Tags Session