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Project
  • Publication
September 29, 2022
Hydroxychloroquine/chloroquine for the treatment of hospitalized patients with COVID-19
Real World Evidence , Research, Development, & Regulatory Roundtable (R3) , Bioethics Collaborative
  • Publication
August 13, 2022
Can Observational Analyses of Routinely Collected Data Emulate Randomized Trials?
Real World Evidence
  • Presentation
March 18, 2021
Role of Real World Evidence and ICH-E17: A provocative perspective
Real World Evidence
  • Presentation
February 16, 2021
Evaluating RWE from Observational Studies in Regulatory Decision-Making: Lessons Learned from Trial Replication Analyses
Real World Evidence
  • Publication
December 18, 2020
Real-World Evidence: Understanding Sources of Variability Through Empirical Analysis
Bioethics Collaborative , Real World Evidence
  • Presentation
June 18, 2020
Observational Patient Evidence for Regulatory Approval and understanding Disease (OPERAND)
Real World Evidence
  • Publication
December 19, 2019
Adding Real-World Evidence to a Totality of Evidence Approach for Evaluating Marketed Product Effectiveness
Real World Evidence
  • Annual Report
December 4, 2019
2019 MRCT Center Impact Report
Global Regulatory Engagement , Real World Evidence , Impact of Privacy Laws on Clinical Research , Promoting Global Clinical Research in Children , Health Literacy in Clinical Research , Diversity, Inclusion, and Equity in Clinical Research , Bioethics Collaborative , Research, Development, & Regulatory Roundtable (R3) , Proactive Safety Surveillance: A Global Approach , Data Sharing , Advancing the Quality of Clinical Trial Enterprise , Training & Education , Joint Task Force for Clinical Trial Competency
  • Publication
November 25, 2019
Understanding the Need for Non-Interventional Studies Using Secondary Data to Generate Real-World Evidence for Regulatory Decision Making, and Demonstrating Their Credibility
Real World Evidence
  • Publication
September 26, 2019
Determining Real-World Data’s Fitness for Use and The Role of Reliability
Real World Evidence