The NESTcc Methods Framework promotes overall study design, outlining key principles and evidentiary requirements for disease and device information, target population and patient selection, study outcomes and procedures, monitoring and statistical analysis.

Download the Framework

  • Ensure projects can be interpreted based on efficient, appropriate, and rigorous methods of analysis
  • Consult a “living playbook” for designing, executing, and evaluating research studies with RWD
  • Learn device-specific considerations in benefit/risk studies based on both observational and experimental designs