Patient Protocol Engagement Toolkit

Select Patients & Appropriate Engagement Method
Things to Consider When Selecting Patients
What Type of Patient Engagement Method Will Help Achieve the Objective(s)?
Example Methods of Engagement
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Things to Consider When Selecting Patients
Things to Consider When Selecting Patients
What Type of Patient Engagement Method Will Help Achieve the Objective(s)?
Example Methods of Engagement

Things to Consider When Selecting Patients

Having patients be part of your clinical study planning can provide important insights. Carefully selecting patient partners is a critical step to obtaining meaningful patient insights. Consider the following patient criteria when evaluating the types of patients to best support your needs:

  • Your access to patients (via patient groups, patient advocates) or need to engage with a third-party vendor
  • Need to engage with caregivers in addition to/instead of patients
  • Where patients are in their patient journey (influencers, family dynamics, community)
  • Variety of treatment experience
  • Disease state/co-morbidities
  • Diversity (demographics, education, literacy levels, socioeconomic backgrounds, geography, language)
  • Perception of clinical studies specific to the patient population
  • A mix of naïve and experienced patients/advocates to create a comprehensive voice
  • Patients with varying degrees of exposure to/involvement in clinical studies

What Type of Patient Engagement Method Will Help Achieve the Objective(s)?

Consider the internal budget and timelines. Consider the outcome you hope to gain to help determine meeting type

  • Direct vs. indirect patient engagement:
    • Will third-party moderator be utilized or will sponsor company to facilitate and lead?
    • Sponsor name may be preferred to be kept anonymous to patients as to not create bias.
    • Ensure all present are well prepared to have effective interactions with patients (e.g., with appropriate language and reactions).
  • Regardless of the type of meeting, be sure to prepare engaging interactive activities to get patients comfortable discussing themselves and their condition

Consider having an experienced moderator/facilitator, as this is highly recommended for all meetings with patients Moderator/facilitator should be able to create a comfortable environment and should not use corporate jargon/acronyms Consider scheduling engagements so relevant sponsor team members can engage firsthand or observe the interactions with patients (e.g., regulatory, clinical development leads, operational lead, etc.)

Example Methods of Engagement

Example Engagement Types
Description
Resource Burden
Cost
Time
Proposed Use
Patient Advisory Board (PAB)
Live meeting. Multiple patients and sponsor representatives.
High
High
High
Use with new indication (no prior sponsor knowledge) and/or high number of consideration needs identified. Patient Advisory Boards typically remain available for a contracted period of time as protocol consultants.
Focus Group/ Interviews
Live meeting. Multiple patients and sponsor representatives.
High
Med
High
Use with new indication (no prior sponsor knowledge) and/or high number of consideration needs identified.
1:1 Face-to-Face Meeting
Live meeting. Single patient and sponsor representative(s).
Med
Med
Med
Use when it is more practical for interviewer to travel to patients (e.g., some diseases may limit ability of patients to travel). Use when questions to be answered include being able to observe a patient in their environment.
Virtual Meeting (e.g., WebEx)
Engaging with patients via the internet using integrated audio and video.
Med
Med/Low
Med
Use when travel may be difficult for patients or there are budget and/or time limitations. Allows for more flexibility to hold the WebEx outside of working hours to be respectful of the patient’s time.
Social Listening/ Social Media
Utilizing social media to gain patient insights.
Med
Med
Low
Use when a quick read on patient perspective is needed. What are patients talking about, what are some key/current concerns, etc.?
Questionnaires/ Surveys
Engaging with patients in a live meeting or virtually via a series of questions/ratings to gain patient feedback.
Low
Med
Low
Use when feedback is desired from large number of patients. Questions can be answered with multiple choice, rank order, minimal open text fields (the latter difficult to analyze).