Skip to main content

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

From: Co-creation of practical “how-to guides” for patient engagement in key phases of medicines development—from theory to implementation

How-To Guide Summary Contributors
Core Team (N) Stakeholder Groups Represented in the Core Team Reviewers (N)
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)
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)
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)
  1. a Contributors include core team members of the WG (defined as those who were actively involved in most aspects of each activity from conceptualization and design to co-development and delivery) and reviewers (defined as those who reviewed and provided feedback on draft guidance/outputs and/or participated in review rounds)
  2. *Review will take place in Q2 2021