ENROLLMENT
35%
52 / 150 patients
BUDGET
50%
$1.5M /$ $3.0M
SCREEN FAILURES
46.4%
vs 20.0% benchmark
ACTIVE SITES
1
2.5 total FTE
MILESTONES
2/6
33% complete
ENROLLMENT TRENDS
No projection data available
BUDGET BREAKDOWN
TOTAL BUDGET
$3.00M
CONSUMED
$1.50M
50%
REMAINING
$1.50M
+3% INF$1.54M
Passthrough
$1.20M (40%)
40%
Investigator Fees
$0.75M (25%)
25%
Consumed
$1.50M (50%)
50%
Remaining
$1.50M (50%)
50%
AVG COST PER PATIENT
$20,000
CURRENT BURN RATE
$28,846.154/pt
SITE PERFORMANCE
| SITE | STATUS | ENROLLMENT | TARGET | PROGRESS | SCREEN FAIL | FTE |
|---|---|---|---|---|---|---|
Knoxville | 52 | 150 | 35% | 46.4% | 2.5 |
RISK REGISTER
HIGH PRIORITY (3)
25
Extremely high screen failure rate due to restrictive spirometry criteria
P:5 × I:5 • ENROLLMENT
Mitigation: Emergency protocol amendment requested to relax FEV1 criteria
20
Study may not complete on time or budget
P:5 × I:4 • BUDGET
Mitigation: Sponsor reviewing feasibility; may close site or amend protocol
16
Single site creates enrollment bottleneck
P:4 × I:4 • OPERATIONAL
Mitigation: Proposal to add Memphis site as backup location
MILESTONES
First Patient Enrolled
Target: 4/15/2024 • Completed: 5/2/2024
25% Enrollment
Target: 10/1/2024 • Completed: 1/15/2025
50% Enrollment
Target: 4/1/2025
75% Enrollment
Target: 10/1/2025
Last Patient Enrolled
Target: 3/31/2026
Database Lock
Target: 10/31/2026
TRIAL INFORMATION
Protocol Version:4.0
Sponsor:PulmoTech Pharmaceuticals
CRO:PPD
Therapeutic Area:Pulmonology
Start Date:4/1/2024
Est. Completion:10/31/2026
Passthrough:$1.20M
Per Patient:$8,000
Investigator Fees:$5,000/pt