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Designing, Integrating, and Analyzing RCT/RWE in Safety Decision Making

Learn more about safety signaling and causal assessment, design considerations for pragmatic and observational trials for safety as well as evaluation and safety analytical approaches with this on-demand course.


In recent years, there has been increasing interest in real world evidence for regulatory decision making (eg FDA RWE framework, ICH E8 R1) while promoting clearly defined scientific questions and causal assessment (eg ICH E9 R1). These interests are particularly tangible in aggregated safety evaluation from randomized clinical trials (RCTs) and real-world evidence (RWE). In this on-demand course, learners will review the evolving landscape and describe key components of safety signaling and causal assessment. Design considerations for pragmatic and observational trials for safety evaluation will be summarized and safety analytical approaches with illustrative examples will be highlighted.

This on-demand training course takes an average of 3 hours to complete. Learners have access to the course for one year from the date of purchase.

What you will learn

  • Evolving Landascape of Safety Evaluation
  • Signal management and Causal Assessment
  • Pragmatic Trials
  • Elements of Observational Studies
  • Safety Signal Detection
  • The Sentinel System
  • Multicourse Data
  • Analysis Methodologies

Who should attend?

This program is designed for rofessionals from industry, academia, and government involved in all phases of the medical product lifecycle who are interested in the application of statistics to advance biopharmaceutical development and accessibility including:

  • Biotechnology
  • Clinical Data Management/eClinical
  • Comparative Effectiveness/Health Technology Assessment
  • Clinical Safety/Pharmacovigilance
  • Clinical Research
  • eClinical
  • Pharmacology
  • Quality Assurance, Control
  • Regulatory Affairs
  • Research & Development
  • Study Endpoints/Clinical Outcomes Assessments

Learning objectives

At the conclusion of this course, participants should be able to:

  • Recognize the evolving landscape in safety evaluation with randomized and observational evidence
  • Identify the key signal management components and key safety considerations for RCT/RWE
  • Utilize analytical methods for observational and randomized data sources

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