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:
Program structure: How do you ensure your programme is compliant with the policies limiting direct-to-consumer communication?
Privacy safeguards: What safeguards do you have in place to protect patient privacy?
Distance maintenance: Do you engage a third party to ensure that you are not a) perceived as practicing medicine, or b) paying state employees for nurse educator services?
Safety data collection: Have you structured your programme with appropriate requirements to gather adverse event and safety data?
Procedures and business processes: Do you have written procedures and processes in place to develop and implement a monitoring programme to provide visibility into these activities’ management and compliance?
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