Unmet clinical needs

Themen dieses Kurses

• Tutorial
  

  Tutorial

  The unmet clinical need checklist produced by the EFLM Test Evaluation Working Group (TE-WG) is a practical tool to assist the work of professionals involved in the discovery or implementation of new biomarkers. The tool is aligned with the IOM recommendations and the FDA and CE regulating body’s requirements. An interactive version of the checklist is available in this course. We encourage pilot testing and regular use of the checklist and the TE-WG would appreciate feedback which would inform future refinements of the checklist based on users’ experience.

  A short overview about this course

   

   

  • Using the checklist (Example) Aufgabe
  • Tutorial Lektion

    This tutorial leads you step by step through the checklist and offers practical examples to understand each step.

  • Pathway mapping template Datei
  • Pathway mapping templates Model answers Datei
  • Unmet clinical needs - checklist template Datei

    This checklist template offers a series of questions that carry you through the key steps of assessing unmet clinical needs for biomarkers. If you wish to receive feedback from TE-WG experts after answering these questions, please upload the filled in checklist to "Using the checklist
    

• Discussion forum, feedback
  

  Discussion forum, feedback

  • Discussion forum
  • Feedback Link/URL

    As the interactive checklist is in its pilot phase and further improvements will be based on users´ reactions, your feedback is essential for us.
    

• Backoffice
  

  Backoffice

  • Glossary

    Glossary of terms (terminology and key principles).