Analytic Strategies of Using Propensity Scores in Clinical Data Augmentation

• Activity Number: 273 - How Advanced Analytic Tools Deliver Insights for Clinical Investigations Through Real World Data
• Type: Invited
• Date/Time: Tuesday, July 30, 2019 : 8:30 AM to 10:20 AM
• Sponsor: Biopharmaceutical Section
• Author(s): Junjing Lin* and Margaret Gamalo-Siebers and Ram Tiwari
• Companies: AbbVie and Eli Lilly and CDRH, FDA
• Keywords: propensity scores; data augmentation; causal inference; historical control; real world data; electronic health records

Abstract

To obtain marketing approval of a therapeutic product, the statutes require manufactures to demonstrate substantial evidence of effectiveness through the conduct of adequate and well-controlled studies, i.e., the conduct of randomized controlled trials (RCTs). However, these trials are sometimes unfeasible due to their size, duration, cost, or ethical constraints. In this case, data derived from external registry can be useful to complement information provided by RCTs. With the increasing availability of electronic healthcare databases, identifying valid registry records to match with RCT data presents opportunities and challenges. In this talk, different data augmentation schemes based on propensity scores are explored.