Table 1 Summary of how-to guides for PE in early phases of medicines development and contributors

PE in the early discovery and preclinical phases (WG1)

Includes practical guidance on how to:

● Identify key patient partners to gain important insights that help improve early research by identifying and focusing on unmet needs

● Gather patient input to satisfy these needs

● Incorporate PE in developing research methodology

● Foster valuable and long-term partnerships

13

● Patient/advocate/organization/association (n = 4)

● Pharmaceutical industry (n = 4)

● Academia/researchers (n = 3)

● Clinical research organization (CRO)/other service provider (n = 2)

31

PE in the development of a COA strategy (WG2A)

Includes practical guidance on how to:

● Engage patients and caregivers to establish a patient-focused COA strategy

This guide is relevant for phase I–III clinical trials

8

● Patient/advocate/organization/association (n = 2)

● Pharmaceutical industry (n = 5)

● CRO/other service provider (n = 1)

11

PE in clinical trial protocol design (WG2B)

Includes practical guidance on how to:

● Integrate the patient perspective in protocol design and development

This guide is relevant for phase I–III clinical trials

12

● Patient/advocate/organization/association (n = 3)

● Pharmaceutical industry (n = 5)

● Academia/researchers (n = 3)

● CRO/other service provider (n = 1)

N/A*