1. Workstream 1: CIOMS WGXI
Notes from Discussion 10/23

2. Introduction – Notes(in addition to topics discussed in Theresa’s slide deck)
Set the scene: Historical context how patient empowerment has developed, access to information; sociocultural context
Why this book now?
Include definitions
Patient engagement/involvement
Meaningful patient engagement (concepts of inclusivity, representativeness)
Value to various stakeholders of engagement
Patients, carers/caregivers, patient organizations
`Consider special section here or elsewhere on characteristics of reputable patient organizations
Discuss special populations: children, cognitively impaired, rare diseases
Value of engagement (in Theresa’s slides)
Statement somewhere about how access to medicines is out of scope for this document (but note that important to consider needs for patient input to support this early in development
When: Throughout the life cycle

3. Landscape - Notes
Need to ensure literature search of patient engagement initiatives is complete, then categorize in tabular form
Table of regulatory initiatives with global efforts included
Other non-regulatory reports, initiatives tabulated (PFMD, DIA, NHC, EFP etc) to enable writing a summary
Collect life cycle graphics (BIO, EUPATI, CTTI) and decide which to use; (? Create new one)—utilize for regulatory / sponsor interactions— depiction of what this looks like from Discovery on through LOE

4. Guiding Principles - Notes
Change title of section from “Rules of Engagement” to “Guiding Principles”
In addition to topics outlined in Beverly’s slide deck, the following topics were suggested:
Communications between/amongst stakeholders
Setting expectations
Communicating uncertainty
Ensuring information fed back to participants in patient engagement activites (should be in patient involvement in drug dev section also)
Patient Rights – Elizabeth, Kaisa will look into Patient Bills of Rights and see if applicable here
Contracting (WECAN initiative—patient friendly language)
Health Literacy—refer to body of work
Compensation – Fair Market Value
Data privacy/Data ownership/data sharing, including genetic data, placebo data sharing for future discovery—collaborate with Group 2 (Future directions?

5. Additional Considerations: Parking Lot
Consider executive summary each section in patient friendly language
Consider section for patients on how to find information on clinical trials/disease state information—make sure global
Characteristics of reputable patient organizations in here as well
Where should capacity building for all stakeholders in ecosystem for sustainability be mentioned?
Issue of Prevention/non medicinal treatments vs. medicines— how/where to address