Objective 1
Gain a better understanding of the disease burden and unmet needs of Parkinson’s Disease patients and caregivers
Use CaseDisease Burden and Endpoint Selection
Listening to the Patient Voice to Understand Disease Burden and Inform Patient-Centric Study Design
Our client was in the process of developing a Phase II Parkinson’s Disease study. In order to support a truly patient-centric study design, the client wished to listen to patients impacted by PD movement disorders in order to: a) understand disease burden, and; b) inform both study endpoint selection and overall design.
Industry:Pharmaceutical
Type:Phase II Clinical Trial Design
TrialPulseDisease BurdenEndpoint SelectionParkinson's DiseaseClinical Trial DesignPatient-Centric ResearchVoice Research
Objective 2
Obtain patient feedback and recommendations on the initial design and key study parameters of the proposed Phase 2 clinical study
The inVibe Solution
The inVibe Solution
inVibe’s TrialPulse solution allowed our pharmaceutical client to quickly and efficiently deploy a voice-powered research study to better understand disease burden and unmet needs to inform study design.
- Voice-powered research methodology
- Automated phone interview system
- Speech-emotion recognition capabilities
- Interactive reporting dashboard
- Direct patient voice capture and analysis
- Machine learning and acoustic technology
How We Did It
1
Collect
Collect
Within a few days, inVibe recruited 20 Parkinson’s disease patients and loved ones aligned with the trial’s inclusion criteria. Participants joined automated phone interviews to describe symptom burden and react to the proposed study design.
Participants
Total: 20 Parkinson’s disease patients and care partners meeting proposed trial criteria
Method: Automated phone interviews via computer or smartphone
Key Questions
Q1
Disease Burden: Please take a moment to describe how you experience {a specific symptom of Parkinson's Disease}. What words do you usually use to describe your symptoms? How frequently do they occur? Does anything make your symptoms better or worse?
Q2
Disease Burden: What does a ‘good day’ living with Parkinson’s Disease look like for you? And what does a ‘bad day’ look like? Please share as much as you like—our goal is to understand what it’s like to walk in your shoes.
Q3
Study Design: During the {#} weeks of the clinical trial, you would be asked to make {#} visits to the clinic, each lasting {#} hours, as well as have {#} of check-ins with a doctor over the telephone. What are your overall reactions to these requirements, and how willing would you be to complete these responsibilities?
Q4
Study Design: What do you see as potential downsides or challenges to participating in this trial (if any)? Do you imagine any difficulties with swallowing {#} capsules once every day for {#} weeks?
2
Analyze
inVibe’s analysts leveraged their language expertise and advanced NLP tools to process, evaluate and analyze multiple aspects of each response, including content, language, and emotion derived from speech-emotion recognition, allowing for deeper insights, faster.
Techniques
- Content analysis
- Language pattern evaluation
- Speech-emotion recognition
Focus Areas
- What is Said: Symptom burden and study feedback themes
- How it’s Said: Language that signals priorities and pain points
- How it Sounds: Emotional cues that indicate urgency or hesitation
3
Deliver
Deliver
The team gained an interactive online dashboard with voice data, transcripts, and a high-level analysis. inVibe’s analysts walked stakeholders through findings, pointing to specific patient moments that informed endpoint and logistics decisions.
- Interactive online dashboard housing voice data, transcripts, and analysis
- In-house analyst walkthrough connecting insights to patient voice clips
- Audiogram tools to create kinetic text videos
- Listening Labs interactive stories assembled from transcripts, audio, and charts
- Expert Perspective sessions led by inVibe analysts
Grounded the Phase II study design in patient feedback on disease burden and endpoint priorities.
Our client used the research to better understand disease burden, help inform study endpoint selection, and update their conceptual model of symptom impact — ultimately designing a truly patient-centric study. They will also continue to engage with patients throughtout the clinical development continuum to further validate and finalize the study design, identify participation barriers, design the recruitment plan, validate patient-facing materials, and more.
Insights & Next Steps
Key Insights & Recommendations
Based on the insights, inVibe recommended that the team take strategic actions.
Prioritize the symptom dimensions patients value most
Patients reported that it was more important to them (their unmet need) that a future treatment addressed {X} aspect of {a specific} Parkinson’s Disease symptom. Thus informing the client’s conceptual model of symptom impact.
Expand PROs beyond physical measures
Patient Reported Outcomes (PRO) assessments that include not only physical, but also emotional measurements, should be included. Thus informing study design.
Clarify trial logistics early
Assist patients in definitively assessing whether their participation is feasible by providing robust logistical information about trial location, transportation, and compensation.
