WP10 – Biomarker surrogate endpoints in small population groups

The major objective of WP10 is to develop an efficient and feasible framework for biomarker and surrogate endpoints in small population groups clinical trials:

  • A viable framework for biomarker and surrogate endpoint evaluation in small population groups.
  • Proper incorporation of missing-data aspects.
  • Using to a maximal extent design aspects: randomisation methodology, optimal design, adaptive designs, decision theory, mixed models, cross-over trials.
  • Incorporating genetic markers.
  • Incorporating dose-response information.
  • The use of simulation-based and other efficient estimation and evaluation methods.

Lead participant