Clinical Development

Faculty of Psychology and Neuroscience

Clinical Development

Full course description

Students will become acquainted with the concept of a clinical development plan and the critical path of studies in early and late development. 

The final assessment for this course is a numerical grade between 0,0 and 10,0.

Course objectives

Students will be able to understand:

  • target product profile, single ascending dose studies, multiple ascending dose studies, experimental medicine studies, dose finding, proof of concept, efficacy, safety;
  • phases of clinical development (I-III) and special cases, i.e. development of anti-cancer drugs and biologicals as models for drug development in neuroscience;
  • role of biomarkers in patient stratification, target engagement and outcome/efficacy prediction;
  • novel trial formats, e.g. adaptive trials, single-case observations, non-Bayesian statistics;
  • relevant outcome parameters versus surrogate parameters;
  • recent cases of development failures and reasons;
  • drug repurposing and repositioning;
  • development pipelines.
PSY4820
Period 4
3 Feb 2025
4 Apr 2025
Print course description
ECTS credits: 
4.0
Instruction language: 
English
Coordinators:
  • R. Schreiber
  • P.R.A. Heckman
Teaching methods: 
Lecture(s), Assignment(s), PBL, Presentation(s)
Assessment methods: 
Attendance, Presentation, Final paper
Keywords: 
drug development, phase I, phase II, phase III, phase IV, proof of concept, dose finding, biomarkers, outcomes, trial design, repurposing/repositioning