1. Collaboration Across the Lifecycle of Treatment Development and Safe Use – Contributions from Stakeholders
Early Development
Later Development
Regulatory approval
Healthcare delivery
Safety monitoring
Health communication
Patients
Describe living with disease
Describe being treated
Describe needs, goals, and wants
Co-create / review research plans
Co-create / review information for patients
Give input to include in dossiers
Review dossiers
Give input to regulators
Learn about treatments
Talk about treatments and goals with HCP
Tell HCP / sponsor / regulator about side effects
Co-create / review non-promotional information
Co-create / contribute (to) good information guidance
HCPs
Talk with / listen to patients about their needs, goals, and wants
Talk with patients about interest / eligibility for clinical trials
Talk about standard treatment
Give input on current treatment regimens
Learn about safe and appropriate use of product
Report side effects promptly
Co-create / review / distribute non-promotional materials
Sponsors
Co-create / request patient review of research plans; incorporate needed changes
Co-create / request patient review of information for patients; incorporate needed changes
Include patient input in dossiers
Propose patient-oriented labeling
Monitor safety and effectiveness of treatments in patient-friendly ways
Co-create non-promotional information per guidance
Regulators
Invite / attend public discussions of patients’ diseases, treatments, needs, goals, and wants
Talk with sponsors and patients about development plans
Co-create / provide guidance on including patients’ input in treatment development
Include patient input in review of dossiers
Co-create / provide guidance on including patients’ input in non-promotional information