3-STEPS STRAGETY FOR PATIENTS EARLY ACCESS TO AN UNAUTHORIZED MEDICATION / DEVICE PROJECT DESIGN (BASED ON 23 PROJECTS ANALYSES INCLUDING EAP, CUP, NPP, IND, ATU)

Author(s)

Kolochavina M¹, Niven D²
¹INC Research, Berlin, UK, ²INC Research, London, UK

OBJECTIVES:

Every expanded access project is unique, thus the goal of this research was to develop a systemic approach that could be implemented for any project on early access independent of the design.

METHODS: RESULTS: CONCLUSIONS:

Despite the complexity and variety of early access project designs in worldwide arena, 3-steps strategy can be implemented in each scenario. It results in fewer burdens for all parties involved, and is effective in meeting the unmet requirements of patient population to be treated within the speed of EAP.

Conference/Value in Health Info

2017-11, ISPOR Europe 2017, Glasgow, Scotland

Value in Health, Vol. 20, No. 9 (October 2017)

Code

PRM243

Topic

Study Approaches

Disease

Multiple Diseases

Presentation