Table 4

Summary of the patient engagement (PE) examples selected for the Book of Good Practices and results of their assessment using the PE quality criteria

Case studyStages of medicine lifecycleEstablished by
(geography)
Assessment results: number agreed that the case addresses a quality criterion
Shared purposeRespect and accessibilityRepresentativenessRoles and responsibilitiesCapacity and capabilityTransparency and communicationContinuity and sustainability
1 Discovery, clinical development phases I–III, registrationAdvisory group
(Spain)
2 Postregistration/launchBiopharma company
(USA)
3 DiscoveryPatient organisation
(USA)
4 Clinical development (phase II–III), postregistration/launch including phase IVBiopharma company
(UK)
5 DiscoveryPatient organisation
(UK)
6 Clinical development (phases II–III)Patient organisation
(UK)
7 Clinical development (phases I–III), postregistration/launch including phase IVBiopharma company
(Switzerland)
8 AllBiopharma company
(Switzerland)
  • Examples were assessed for inclusion in the Book of Good Practices by the Core Team which comprised 10 participants. It was required that the majority (ie, ≥6) had to agree that the example demonstrated each of the PE Quality Criteria and should be included in the Book of Good Practices. All examples included in the Book of Good Practices demonstrated each of the seven PE Quality Criteria (indicated by ·). In addition, greater than or equal to six Core Team members had to agree that a specific example particularly exemplified specific PE Quality criteria (indicated by ❖). All PE examples were initiatives involving patient organisations rather than unaffiliated patients.