Patient Protocol Engagement Toolkit

Use Cases

In these use cases you will find:

  • Examples of particular problems encountered by sponsors
  • Example insights gathered by the sponsors as a result of patient engagement
  • Example actions taken by the sponsors as a result of the patient engagement insight
Timing/Volume of Procedures Used in a Clinical Study

Problem:

  • The study team was unsure of both the number and timing of procedures.
  • Were they out of sync with the practical realities of the health care system or patient lives?

Insight:

  • Patients provided their comments on the acceptability of the proposed procedures and associated timings.

Action:

  • Through patient and site collaboration, the sponsor redesigned the schedule of procedures.
Invasive Procedure

Problem:

  • The study team was considering requiring an invasive procedure in immunocompromised patients.

Insight:

  • Patients informed sponsor that this would negatively impact willingness to participate.

Action:

  • The protocol was changed to make the procedure optional.
Drug Appearance

Problem:

  • Multiple pills involved in treatment therapy were similar in appearance.
  • Presented a new opportunity for our drug manufacturing to explore how they might consider patient input in their work beyond the size and taste of a pill.

Insight:

  • Patients helped to create solutions to better discern the different pills and any associated activities.

Action:

  • Creative solutions were implemented to help improve drug compliance and prevent possible medication error.
Improving Recruitment & Retention

Problem:

  • Previous experience demonstrated patients are challenging to recruit to studies.

Insight:

  • The proposed duration of visits and frequency of tests were burdensome.
  • Patients appreciated the proposed ePRO.

Action:

  • Reduced duration of visits and frequency of tests, as time burden was a key patient concern.
  • The decision to proceed with ePRO in response to positive patient feedback.

Outcome:

  • Reduced screen failures, reduced drop-outs, increased enrollment rate, zero (0) avoidable amendments.
Patient Reported Outcomes (PROs)

Problem:

  • The study team wanted to further understand what type of outcomes from their treatment mattered most to patients, including physical, emotional and social functioning.

Insight:

  • Interviews & surveys highlighted the importance of the ability to function and partake in daily activities.

Action:

  • Developed an instrument to capture these PROs during trials.
  • Developed a clinical practice tool to capture patient experiences.

Outcome:

  • Included objective data on the results for the MPFID endpoint in the label.
Diverse Populations

Problem:

  • The study team wanted to determine how to meet the needs of a diverse patient population.

Insight:

  • Gained information on patients’ overall perspective of clinical studies, their decision-making process, barriers, and motivating factors impacting participation and raising disease awareness.

Action:

  • Focused efforts on educational initiatives related to patients’ general knowledge and perceptions of clinical trials and educated investigators on patient educational needs while enrolling.
  • Worked to facilitate the use of more diverse imagery in clinical trial materials.
  • Added as much specific information related to prior trials and the present trial to patient materials as possible.
  • Included patient feedback during the development of patient brochures and other educational materials.
Exit Interviews

Problem:

  • The study team wanted to understand the patient perspective on the clinical trial experience.

Insight:

  • Important concepts and dominant trends in each interview were identified, and results were compared across interviews to allow for the generation of themes or patterns in participants’ responses.

Action:

  • Qualitative information provided additional data to assist in interpreting the quantitative data from the trial, giving an in-depth understanding of patient experiences and can be used for future hypothesis generation.
Reducing Patient Burden

Problem:

  • Patients perceive a high burden of participating in a clinical trial.

Insight:

  • Proposed duration of visits and frequency of tests were burdensome.
  • Patients appreciated the proposed ePRO.

Action:

  • Reduced duration of visits and frequency of tests, as time burden was a key patient concern.
  • The decision to proceed with ePRO in response to positive patient feedback.

Outcome:

  • Reducing burden and improving the patient experience led to reduced screen failures, reduced drop-outs, increased enrollment rate, zero (0) avoidable amendments.