User Research & Validation Plan
Validating the core assumptions behind Clinical Trial Navigator before building
1. Key Assumptions to Validate
Validation Philosophy
For a healthcare product touching vulnerable populations, we prioritize safety, trust, and accuracy over speed. Every assumption must be tested with real patients before coding begins.
Problem Assumptions
| Assumption | Risk | Validation Method | Target Evidence |
|---|---|---|---|
| Patients with serious conditions actively search for clinical trials beyond standard care | HIGH | 20 patient interviews + survey (n=200) | ≥70% confirm active search behavior |
| ClinicalTrials.gov is overwhelming and causes patients to miss relevant trials | HIGH | Usability testing of current site + interview questions | ≥80% report confusion/frustration |
| Geographic/logistical barriers are a primary reason for trial non-participation | MEDIUM | Caregiver interviews + data analysis of trial locations | ≥50% cite distance/travel as barrier |
| Patients want to track multiple trials and get notifications | LOW | Feature prioritization survey | ≥60% rank tracking as top 3 feature |
Solution Assumptions
| Assumption | Risk | Validation Method | Target Evidence |
|---|---|---|---|
| AI can accurately translate eligibility criteria to plain language | CRITICAL | Expert review (doctors, trial coordinators) of AI output | ≥95% accuracy, zero harmful errors |
| Percentage-based match scores are helpful, not misleading | HIGH | Prototype testing with patients + clinical advisors | ≥80% find scores useful with clear explanations |
| Patients will trust AI-generated "Patient Briefs" | MEDIUM | A/B test: AI vs human-written summaries | No significant trust gap (p<0.05) |
| Mobile-first PWA is the right delivery format | LOW | Device usage survey + prototype testing | ≥70% prefer mobile for healthcare research |
Business Assumptions
| Assumption | Risk | Validation Method | Target Evidence |
|---|---|---|---|
| Patients/caregivers will pay $9.99/month for premium features | CRITICAL | Van Westendorp pricing survey + fake door test | ≥5% conversion at target price in test |
| Pharma/CROs will pay for qualified patient leads | HIGH | 10 conversations with pharma recruitment teams | 3+ LOIs for pilot partnerships |
| CAC can be kept under $30 for patient acquisition | MEDIUM | Small ad tests in patient communities | CAC < $50 in initial tests |
| Hospital systems will license white-label version | LOW | Interviews with 5+ hospital innovation directors | 2+ express strong interest in pilot |
2. Customer Discovery Interview Guide
Interview Framework (60-90 minutes)
Target: 30 interviews (20 patients, 10 caregivers)
Recruitment: Patient advocacy groups, Reddit health communities, hospital referrals
Incentive: $100 gift card + 1 year premium if launched
Logistics
- Format: Video call (Zoom)
- Recording: With consent + Otter.ai
- Note-taking: Standardized template
- Follow-up: 1-week check-in
Part 1: Background & Context (10 min)
- Tell me about your health journey. When were you/your loved one diagnosed?
- What does a typical week look like in terms of managing this condition?
- Who is involved in your healthcare decisions? (Family, doctors, others)
- What's your comfort level with researching medical information online?
Part 2: Problem Exploration (25 min)
- Have you ever looked for clinical trials? What prompted that search?
- Show them ClinicalTrials.gov: Walk me through how you would find trials for your condition. (Observe)
- What's the most frustrating part of this process?
- Have you ever found a trial you thought you qualified for, then discovered you didn't? What happened?
- How do you currently track trials you're interested in? (Spreadsheet, notes, memory?)
- What concerns do you have about participating in clinical trials?
- On a scale of 1-10, how stressful is the trial search process?
Part 3: Solution Exploration (20 min)
Show Figma prototype or screenshots
- If a tool could automatically match you with trials based on your health profile, what would be most valuable about that?
- What concerns would you have about sharing health information with such a tool?
- How would you want eligibility criteria explained to you? (Percentage score? Simple yes/no? Detailed breakdown?)
- Which of these features would be most helpful: notifications for new trials, plain language summaries, travel cost estimates, or something else?
- Would you prefer this as a mobile app or website? Why?
Part 4: Pricing & Adoption (10 min)
- If this tool helped you find a relevant trial, what would that be worth to you?
- Would you prefer a free version with ads, a monthly subscription ($5-15), or a one-time fee?
- What would make you trust this tool enough to enter your health information?
- Would you recommend this to others in your patient community?
3. Validation Experiments
Landing Page Test
Goal: Validate demand and messaging
Setup: 3 variants testing different value props
Metrics: Waitlist signup rate, time on page
Budget: $750 Facebook/Google ads
Success: >7% signup rate (70+ emails)
Wizard of Oz MVP
Goal: Test matching accuracy and UX
Setup: Manual AI matching via Google Form + email
Users: 15 patients from interviews
Success: NPS >40, 80% accuracy verified by MD
Cost: $0 + 20 hours/week
Pricing Fake Door
Goal: Measure willingness to pay
Setup: "Get Premium" button → survey
Test: 3 price points ($4.99, $9.99, $14.99)
Success: >10% click-through, optimal price point
Sample: 500+ landing page visitors
Screening Survey (Patient/Caregiver)
1. What condition are you/your loved one managing?
[Free text, categorized later]
2. How long since diagnosis?
□ Less than 6 months □ 6-12 months □ 1-3 years □ 3+ years
3. Have you researched clinical trials for this condition?
□ Yes, extensively □ Yes, a little □ No, but interested □ No, not interested
4. What's been the biggest barrier to finding trials?
□ Don't know where to look □ Too complex to understand □ Location/distance
□ Don't know if I qualify □ Other: _____
5. Would you use a free tool that matches you with trials and explains them in plain language?
□ Definitely □ Probably □ Maybe □ Probably not □ Definitely not
6. For premium features (unlimited tracking, notifications), what would you pay monthly?
□ $0 (free only) □ $1-$5 □ $6-$10 □ $11-$20 □ $20+
Target: 300+ responses via patient forums and advocacy groups
4. 8-Week Validation Timeline
Problem Discovery Phase
- Recruit 15 patients for interviews
- Conduct 10 patient interviews
- Launch screening survey (target 150 responses)
- Analyze ClinicalTrials.gov usability issues
Solution Validation Phase
- Build landing page with 3 headline variants
- Launch $500 ad campaign
- Create Figma clickable prototype
- Test prototype with 5 patients
- Interview 5 caregivers
Pricing & Accuracy Validation
- Run Van Westendorp pricing survey (n=100)
- Implement fake door pricing test
- Test AI accuracy with clinical advisor (50 trial criteria)
- Start Wizard of Oz MVP with 5 users
- Initial pharma partnership conversations
Synthesis & Go/No-Go
- Complete Wizard of Oz MVP (15 users)
- Measure NPS and satisfaction
- Synthesize all research findings
- Create investor validation deck
- Make build decision based on criteria
Go/No-Go Decision Criteria
| Metric | Target | Rationale | Weight |
|---|---|---|---|
| Problem validation rate | ≥70% | Majority of patients confirm pain point | 25% |
| AI accuracy rate | ≥95% | Medical safety cannot be compromised | 25% |
| Waitlist signup rate | ≥7% | Demonstrates clear demand | 20% |
| Price acceptance at $9.99 | ≥40% | Sustainable unit economics | 20% |
| Wizard of Oz NPS | >40 | Users love the core experience | 10% |
Decision Rule: GO if weighted score ≥75% AND AI accuracy ≥95% (non-negotiable).
Budget for 8 weeks: $3,000 (ads, incentives, tools) + 320 founder hours.
5. Research Synthesis Template
Validated Insights
- Top 3 patient pain points confirmed
- Preferred feature prioritization
- Optimal price point and model
- Trust-building requirements
- Key adoption barriers
Invalidated Assumptions
- Assumptions proven wrong
- Unexpected findings
- Features users don't want
- Pricing misconceptions
- Channel assumptions incorrect
Direct Patient Quotes (Evidence)
"I spent 40 hours researching trials for my daughter's rare condition and still missed one 30 miles away."
— Parent of child with rare disease
"The exclusion criteria are written in language I don't understand. I need someone to translate 'creatinine clearance' to plain English."
— Cancer patient, 58
Next Steps Based on Validation
Proceed to MVP build with validated specs
Iterate on solution based on findings
Document learnings, explore adjacent problems
Clinical Trial Navigator • User Research & Validation Plan
Complete 8-week validation program to de-risk $500K seed investment