For drug trials spanning many international locations and jurisdictions, there are complex challenges involved in designing a Patient Support Programme (PSP) which meets regulatory standards. What types of controls should minimally be embedded into business and governance processes to help manage the multiple risks that may impact PSPs?
Key considerations are:
Everybody recognises that there are many unmet needs for most patients with life-threatening diseases. Patients know their needs best, but rarely have the broad know-how on how the highly regulated and complex R&D process works.”
Executive Director of the European Patients' Forum and Coordinator of Eupati