biostudies-literatureStrom JBNational, Heart, Lung, and Blood InstituteNCATS NIH HHSAmerican Heart Association-American Stroke AssociationNHLBI NIH HHS64-71https://www.ebi.ac.uk/biostudies/studies/S-EPMC6535119biostudies-literatureUnknown212<h4>Background</h4>Randomized controlled trials are the "gold standard" for comparing the safety and efficacy of therapies but may be limited due to high costs, lack of feasibility, and difficulty enrolling "real-world" patient populations. The Extending Trial-Based Evaluations of Medical Therapies Using Novel Sources of Data (EXTEND) Study seeks to evaluate whether data collected within procedural registries and claims databases can reproduce trial results by substituting surrogate non-trial-based variables for exposures and outcomes.<h4>Methods and results</h4>Patient-level data from 2 clinical trial programs-the Dual Antiplatelet Therapy Study and the United States CoreValve Studies-will be linked to a combination of national registry, administrative claims, and health system data. The American heart journalValidating the use of registries and claims data to support randomized trials: Rationale and design of the Extending Trial-Based Evaluations of Medical Therapies Using Novel Sources of Data (EXTEND) Study.PMC6535119K23 HL144907K24 HL150321R01 HL1367081R01HL136708-01UL1 TR00186318CDA34110267Strom JBPopma JJYeh RWMauri LBrennan JMShen CValsdottir LRTamez HCurtis JZhao YfalseValidating the use of registries and claims data to support randomized trials: Rationale and design of the Extending Trial-Based Evaluations of Medical Therapies Using Novel Sources of Data (EXTEND) Study.<h4>Background</h4>Randomized controlled trials are the "gold standard" for comparing the safety and efficacy of therapies but may be limited due to high costs, lack of feasibility, and difficulty enrolling "real-world" patient populations. The Extending Trial-Based Evaluations of Medical Therapies Using Novel Sources of Data (EXTEND) Study seeks to evaluate whether data collected within procedural registries and claims databases can reproduce trial results by substituting surrogate non-trial-based variables for exposures and outcomes.<h4>Methods and results</h4>Patient-level data from 2 clinical trial programs-the Dual Antiplatelet Therapy Study and the United States CoreValve Studies-will be linked to a combination of national registry, administrative claims, and health system data. The 2019-01-01T00:00:00Z2019 Jun2025-04-18T22:08:19.886Z2020-06-04T07:05:44ZS-EPMC65351193095393610.1016/j.ahj.2019.02.007