Executive summary
This sample builds an assumption-driven cost model for PRISE-hATG, a Phase 3 trial of SAB-142 in Stage 3 type 1 diabetes. It separates four kinds of cost: per-site, prospective participant, fixed study-level, and recurring time-dependent. The 36 external SAFEGUARD participants are handled separately from prospective recruitment and treatment.
| Core budget category | Low | Base | High |
|---|---|---|---|
| Per-site costs | $143,080 | $143,080 | $143,080 |
| Prospective participant costs (72) | $1,116,180 | $1,116,180 | $1,116,180 |
| Fixed study-level costs | $186,000 | $409,000 | $891,000 |
| Recurring costs (48 months) | $2,472,000 | $6,242,400 | $12,909,600 |
| Core budget total | $3,917,260 | $7,910,660 | $15,059,860 |
The core budget runs from about $3.92 million to $15.06 million, with a base case near $7.91 million. Recurring operations are the largest driver, particularly in the base and high cases. External-cohort integration is excluded from these totals and estimated separately at $3,200–$17,600, depending on data readiness.
Status of these numbers. They are illustrative planning scenarios built on unverified unit costs, not vendor quotations or forecasts of actual spend. Blended at $100 per hour, the external-data estimate is also illustrative.
Study and planning assumptions
| Parameter | Planning assumption |
|---|---|
| Study | Phase 3, interventional, randomized, double-blind, placebo-controlled; SAB-142 |
| Population | Stage 3 T1D, ages 5–40 |
| Prospective enrollment | About 72 participants, randomized 2:1 |
| External cohort | About 36 participants from SAFEGUARD (data integration only) |
| Sites modeled | 4 U.S. sites (an assumption to verify) |
| Treatment and follow-up | Induction at baseline, maintenance at Month 6, follow-up through Month 12 |
| Budget horizon | 48 months, distinct from each participant’s 12-month primary assessment |
The protocol and full schedule of assessments were not available, so visit counts, procedures, staffing, monthly allocations, and unit costs are planning assumptions. The 48-month horizon is meant to cover the registry’s estimated start, primary completion, and study completion dates.
Method
| Category | Calculation | Driver |
|---|---|---|
| Per-site | $35,770 × 4 sites = $143,080 | Number of sites |
| Prospective participants | $15,502.50 × 72 = $1,116,180 | Prospective enrollment |
| Fixed | Sum of setup work packages, by scenario | Setup scope and complexity |
| Recurring | Monthly estimate × 48 months | Duration and operating intensity |
Low, base, and high are deterministic planning cases reflecting different assumed resource levels. They are not confidence intervals or probability-weighted forecasts. Each activity should have one primary cost category to avoid double counting, and monthly allowances should not hide costs that depend on actual events or volumes.
Because the base monthly recurring estimate ($130,050) is the sum of its listed categories, it replaces an earlier $128,600 figure that did not reconcile.
Consolidated budget and cost drivers
Share of the core budget by category:
- Recurring operations grow from about 63% of the low case to about 86% of the high case, so duration and intensity of management, monitoring, data, safety, technology, and laboratory work move the total most.
- The low-to-high gap is about $11.14 million: $10.44 million from recurring costs and $705,000 from fixed costs. Site and participant totals do not change across scenarios.
- Per-site costs stay under 4% of the total in every case, but they still need review for duplication with central budgets.
Why there is no cost-per-participant headline. Dividing the total by the 108-person combined dataset would blend prospective and external participants. The modeled prospective unit cost is $15,502.50, applied to 72 participants only.
Detailed cost breakdown
Fixed study-level costs
| Work package | Low | Base | High |
|---|---|---|---|
| Study design and regulatory coordination | $41,500 | $75,500 | $150,000 |
| Study startup and management systems | $28,000 | $61,500 | $130,000 |
| Data management setup | $9,000 | $19,000 | $38,000 |
| Safety setup | $15,000 | $32,000 | $70,000 |
| Laboratory and biomarker setup | $20,000 | $47,000 | $120,000 |
| Investigational product preparation | $14,000 | $37,000 | $87,000 |
| Quality management | $12,000 | $26,500 | $53,000 |
| Project governance | $8,000 | $17,500 | $35,000 |
| Statistical and reporting setup | $14,000 | $33,000 | $67,000 |
| Technology and security | $15,000 | $39,500 | $100,000 |
| Study closeout preparation | $9,500 | $20,500 | $41,500 |
| Total fixed | $186,000 | $409,000 | $891,000 |
Per-site costs: $35,770 per site
| Category | Per site |
|---|---|
| Site feasibility and qualification | $2,950 |
| Site initiation and activation | $5,050 |
| Regulatory submissions and coordination | $4,550 |
| Training | $2,950 |
| Site management allowances | $1,400 |
| Participant-facing activities | $5,270 |
| Site changes and contingencies | $8,950 |
| Closeout | $4,650 |
| Total per site | $35,770 |
Four sites give $143,080. The site-management line assumes 20 specimen shipments at $40 each plus a turnover and onboarding allowance, and excludes courier and laboratory charges.
Per-participant costs: $15,502.50 per prospective participant
| Category | Per participant |
|---|---|
| Screening | $1,550.00 |
| Enrollment | $1,275.00 |
| Study visits | $9,390.00 |
| Follow-up | $1,432.50 |
| Participant reimbursement | $1,855.00 |
| Total per participant | $15,502.50 |
Across 72 participants this is $1,116,180. Study visits include $600 for study-drug administration and $500 for infusion monitoring, which are not added separately. External participants are excluded because their historical participation does not by itself imply new costs.
Validation flag. The visit estimate includes $900 per participant for visit payments, and the reimbursement category includes a separate $900 stipend. Confirm these are distinct payments, and remove any duplication before finalizing.
Recurring costs: monthly estimates over 48 months
| Category | Low / month | Base / month | High / month |
|---|---|---|---|
| Central project management | $13,750 | $26,500 | $46,500 |
| Monitoring and quality oversight | $6,250 | $16,000 | $32,500 |
| Site management | $4,800 | $9,200 | $16,950 |
| Data management | $6,500 | $14,500 | $28,750 |
| Statistical support and analysis | $3,000 | $10,500 | $23,500 |
| Pharmacovigilance and medical monitoring | $6,500 | $15,750 | $31,000 |
| Technology and infrastructure | $4,200 | $13,400 | $26,500 |
| Laboratory and specimen operations | $3,500 | $9,250 | $22,250 |
| Recruitment and timeline contingencies | $3,000 | $14,950 | $41,000 |
| Total per month | $51,500 | $130,050 | $268,950 |
| Total over 48 months | $2,472,000 | $6,242,400 | $12,909,600 |
These assume the service profile continues for all 48 months. In practice, work such as interim analyses, amendments, and closeout is milestone-driven. Monitoring visits and travel must not be counted under both central monitoring and site management.
External-cohort data integration (excluded from core totals)
| Scenario | Assumed data readiness | Effort | Cost at $100/hr |
|---|---|---|---|
| A. Analysis-ready | Authorized de-identified dataset, data dictionary, and harmonized endpoint variables supplied | 32–64 hours | $3,200–$6,400 |
| B. Additional preparation | Sponsor must prepare and transfer data, with field mapping, endpoint and time-point reconciliation, and quality review | 88–176 hours | $8,800–$17,600 |
Both include coordination, harmonization, eligibility and source-data review, quality review, integration programming, and documentation. They exclude new recruitment, treatment, visits, reimbursement, sponsor access fees, and substantial remediation of missing or inconsistent data. Choose a scenario after reviewing the sponsor’s data readiness.
Sensitivity and contingency
The three cases reflect combined changes in fixed and recurring assumptions. They do not isolate the cost of any single risk, so the gap between high and low is not the price of a particular delay.
| Risk factor | Potential financial effect | Inputs to validate |
|---|---|---|
| Enrollment delay | Longer recruitment, site support, and downstream timelines | Enrollment rate, screen failures, duration |
| Study extension | More central, site, and vendor services and licenses | Extension length; workstreams that stay active |
| Additional monitoring | More visits, travel, quality reviews, issue resolution | Risk-based monitoring plan; site performance |
| Repeat testing | More assay, processing, shipment, and visit costs | Repeat rates and protocol rules |
| Higher safety workload | More case processing, medical review, reporting | Expected event volume and reporting scope |
| Data or analysis rework | More reconciliation, programming, analysis | Data quality, external feeds, amendment frequency |
Financial controls
- Reconcile every itemized line to its category and the consolidated totals before external use.
- Add an incremental contingency only after checking whether fixed, site, participant, or recurring allowances already cover the activity.
- Forecast by phase (startup, enrollment and treatment, follow-up, analysis, closeout) once a timeline exists.
- Set reforecast triggers: enrollment below target, completion-date slippage, extra monitoring, repeat testing above plan.
Stress tests such as three- or six-month extensions or higher monitoring and safety volumes are scenario inputs, not predictions. Quantifying them requires validated unit costs and a map of which services continue during each event.
Feasibility and operational implications
The model supports preliminary planning. It does not show the study is operationally feasible at the modeled cost. Questions for sponsor and vendor review:
- Can four sites recruit 72 prospective participants on schedule given the eligibility criteria and age range?
- What site capabilities and safety and laboratory workflows do the treatment and MMTT assessments need?
- Which services are sponsor-, CRO-, site-managed, or provided by specialist vendors?
- What SAFEGUARD data are available, under what permissions, and in what format?
- Which recurring services run all 48 months, and which concentrate in particular phases?
- Do site payments, participant stipends, shipments, monitoring, data queries, or closeout appear in more than one category?
Benchmark context
Published cost studies show how widely trial budgets vary, but none validates these line items.
| Reference | Use here | Limitation |
|---|---|---|
| Sertkaya et al. (2016) | Context for Phase 3 cost variation and drivers. Reported average costs of roughly $11.5M–$52.9M across selected therapeutic areas. | Data from 2004–2012, not inflation-adjusted; areas and definitions differ |
| Analysis of 225 pivotal trials (2020) | Context for trial-level and per-patient cost. Estimated a median of $19M per trial and $41,413 per patient. | Relied partly on default assumptions; excluded some sponsor costs such as design, contract monitoring, and medication |
Any comparison should keep each source’s year, cost definition, population, and scope. Actual site budgets and vendor quotations are needed to replace planning estimates.
Recommended next steps
| # | Action | Output |
|---|---|---|
| 1 | Obtain protocol and schedule of assessments | Verified visit and procedure quantities and timing |
| 2 | Confirm site list and enrollment plan | Validated site count, enrollment assumptions, site scope |
| 3 | Reconcile participant payments and treatment responsibilities | No duplicated stipends or unpriced treatment obligations |
| 4 | Confirm sponsor and vendor ownership by workstream | Responsibility matrix; overlaps removed |
| 5 | Review site budgets and vendor quotations | Study-specific commercial rates |
| 6 | Review SAFEGUARD data readiness | Choice of Scenario A or B |
| 7 | Build a phase-based forecast and sensitivity model | Timing-aware baseline and incremental risk exposure |
Recommended use. Treat this as a structured planning baseline for sponsor discussion and scope definition, not a contracted budget.
Limitations and exclusions
- The full protocol and schedule of assessments were unavailable, so visit counts and procedures are illustrative.
- The four-site configuration and 48-month horizon are assumptions.
- Some investigational-product and treatment lines have no unit rate entered. A $0 means no cost has been entered, not that the product or activity is free.
- Unit costs and monthly allocations are not quotations or validated market rates.
- Duplication may exist across participant payments, site and central monitoring, regulatory work, specimen handling, data queries, and closeout.
- Taxes, institutional overhead, currency effects, inflation, and contract minimums are not confirmed as represented.
- Clinovia makes no representation that actual costs will fall within the modeled range.