Observational research is increasingly being required to address the issues of product safety and clinical, economic, and humanistic value in actual practice (i.e., real world) settings. However, design methods and operational approaches used for more traditional (pre-approval) forms of research are inappropriate for observational studies. This presentation addresses the strategic underpinnings of observational research, provides a contrast with more traditional (e.g., RCTs) research approaches, and presents findings from an on-going industry survey on the topic, revealing both important challenges and opportunities for improved consensus.
Identify the factors (safety and value) underlying the need for observational research programs.
Identify key design and operational differences between observational studies and other forms of research (e.g., RCTs).
Identify critical internal (organizational) and external (environmental) challenges that can compromise the development and deployment of observational (""real world"") studies.