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