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