Patient Protocol Engagement Toolkit

What is the Patient Protocol Engagement Toolkit (P-PET)?

The Patient Protocol Engagement Toolkit (P-PET) is a comprehensive set of materials that sponsors and other stakeholders can use to engage patients during protocol development. The goal of this engagement is to improve patient experience and reduce patient burden as a study participant.

The P-PET can be utilized by sponsors to partner with patients in creating patient-centric clinical studies.

The P-PET is a comprehensive set of materials that can help biopharmaceutical companies and other stakeholders engage with patients during the study design phase (e.g., as early as the protocol concept).

Components of the P-PET include:
  • User Guide: The User Guide supports sponsors in (1) understanding the value of implementing the P-PET in their respective clinical studies, (2) understanding how to leverage the P-PET and implement it in a clinical study and share ideas and best practices on how to have meaningful discussions with patients, (3) socializing with stakeholders to seek greater support as needed and (4) providing example case studies.
  • Resource Guide: A set of sample questions for consideration during an engagement with patients. Examples of visual aids are provided to facilitate clear communication of study design and protocol-related concepts to the patients.
  • Templates: Templates to help support engagement discussions with patients and provide feedback to both the study teams and patients.

How the P-PET Might Work:

This is Jan. She is a researcher helping to design a clinical study for a biopharmaceutical company.

This is Amy. She is a patient who has experienced the condition being researched.

Jan in collaboration with a patient engagement moderator/facilitator will use the P-PET to get feedback about the protocol from Amy.

Jan will use the feedback to help improve the design and conduct of the study.

Download the P-PET Documents

Planning for Patient Engagement
Start-Up Considerations
Process Flow for Patient Engagement Activity
Include Patient Insights Early in Program Development and/or Study Planning
Note for Sponsors
Click to navigate between each subsection.
Start-Up Considerations
Start-Up Considerations
Process Flow for Patient Engagement Activity
Include Patient Insights Early in Program Development and/or Study Planning
Note for Sponsors

Start-Up Considerations

Sponsor teams responsible for the design, planning, and conduct of a clinical study/clinical program should consider implementing patient engagement as early as possible in the protocol development lifecycle. The sponsor team could also conduct an assessment of internal support and available resources, including the necessary budget, to support this engagement process. This includes identifying the key roles and responsibilities that drive the engagement process with patients.

Consider leadership
buy-in

Consider your internal SOPs and legal guidance as well as other stakeholder approvals as required

Consider budgetary needs, timelines and resource allocation including the need for 3rd party vendor support

Consider IRB/Ethics Committee review

Consider disease knowledge and patient population insights that may already exist within your sponsor company and how this toolkit may help complement existing insights

Consider how the data resulting from patient engagement activities will be collected, shared, stored, assessed and utilized to design a patient-centric study

Consider who will be the owner of patient experience and engagement activities

Consider establishing roles and responsibilities that will support the process

Process Flow for Patient Engagement Activity

Include Patient Insights Early in Program Development and/or Study Planning

Note for Sponsors

While reviewing the P-PET User Guide please remember that:

  • The use of “patient” throughout can refer to anyone speaking for or representing a patient, for example, patients, caregivers, parents, patient advocates, patient advisors or expert patients.
  • Patient Advisory Board (PAB) may include “patients” who are living with the condition and/or participating in the specific study and/or patients who are eligible for the study.
  • You are asking the “patient” to imagine that they are planning to take part in the study