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Table 5 Summary of How-To Guide for PE in clinical trial protocol design

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

Section Description and purpose/rationale
STEP 1: Preparation for partnership and patient engagement in clinical development Focuses on considerations proposed for sponsors and patient partners before the collaboration starts
Provides practical guidance on how to:
Establish a collaborative approach by understanding patients’ willingness and abilities to contribute to the clinical trial protocol design and implementation of a clinical trial for the treatment of the disease/condition with which they live
Assess the level of interest and expectations from patients and sponsors for the collaboration
Prepare all partners for an impactful collaboration. For example, by providing capacity building activities, such as training and education, on clinical trial protocols and their development; agreeing on common objectives, expectations and time investment required from patients
Establish the foundation for a long-term, collaborative patient-clinical researcher relationship
STEP 2: Building a partnership Focuses on identifying and connecting with potential partners and preparing for the initial meeting to plan the project
Provides practical guidance on
When to set up a partnership
Identifying and reaching out to partners
Planning the first meeting with partners with the PE quality guidance [16]
STEP 3: Patient engagement in clinical trial protocol design Focuses on providing guidance and examples of when and how patients can contribute to protocol design
Guidance and considerations for collecting patient insights, analysis, and feedback
Identification of areas for PE in specific sections of typical clinical trial protocol with examples of key questions and aspects that could be considered in each section (e.g., reflecting patient unmet needs and considering patients’ burden around protocol assessments)
STEP 4: Feedback and follow-up Focus on maintaining relationships with patient partners and contributors for future collaborations
Opportunity to reflect and learn from the project and to assess project impact, including “soft” outcomes
Guidance on what the ongoing contact could encompass (e.g., a reunion)