Recruitment Configuration
Define patient enrollment targets, timelines, and recruitment patterns for your clinical trial.
Overview
Recruitment configuration defines how many patients you expect to enroll, when enrollment starts and ends, and how patients are distributed across your trial countries. This step is the primary demand signal for the entire supply chain forecast — more patients means more kit demand.
This step captures your forecasted recruitment plan. If you have real-world enrollment data, enter it in Step 8 (Actuals) to update the forecast with ground truth.
See Study Setup for an overview of all wizard steps.
Recruitment Modes
Prognosis offers three recruitment modes. Select one using the toggle at the top of the step. You can switch modes at any time, though switching away from Screened or Regional mode clears mode-specific data (with a confirmation prompt).
| Mode | Best For | Key Inputs | Output |
|---|---|---|---|
| Enrollment | Most trials — direct patient counts | Per-country enrollment numbers, dates | Direct demand forecast |
| Screened | Trials with known screen failure rates | Screened counts, failure percentages | Adjusted demand accounting for dropouts |
| Regional | Large multi-country trials | Regional groups, patient totals per region | Coordinated regional enrollment plan |
Mode 1: Enrollment (Recommended)
The simplest and most common option. You enter patient counts directly for each country.
Each country from Step 1 appears as an expandable card with:
- Target Patient Count — Total patients expected to enroll in this country
- First Patient In (FPI) — Date enrollment begins
- Last Patient In (LPI) — Date enrollment ends
- Recruitment Pattern — How patients are distributed over the enrollment window
Collapsed cards show a summary with country name, date range, patient count, and site count. Cards with missing data display an amber left border.
Mode 2: Screened
Adds a screen failure rate so Prognosis calculates how many patients will actually enroll after screening.
Everything from Enrollment mode, plus:
- Screen Failure Percentage — Proportion of screened patients who will not pass screening (0-100%)
The effective enrolled count is calculated as:
Enrolled = Screened x (1 - Screen Failure % / 100)
This calculated value appears as a read-only "Enrolled" count in the card header.
Industry screen failure benchmarks are typically 20-40%. Check your protocol assumptions or historical data for the best estimate.
Mode 3: Regional
Group countries into regions and manage enrollment at the regional level. Prognosis distributes the regional patient total across member countries.
Setting Up Regions
- Type a region name (e.g., "North America", "EMEA", "APAC") and click Create.
- Assign countries to regions using the dropdown on each unassigned country card. Unassigned countries appear in an amber-bordered section.
- Configure each region with total patient count, FPI/LPI dates, and recruitment pattern.
Prognosis distributes the region's total patients evenly across its member countries. For example, 100 patients across 3 countries yields 34, 33, 33 (remainder goes to the first countries).
Patient Count Input Toggle
Each country or region card offers a toggle for how you enter the patient target:
| Input Mode | What You Enter | How It Works |
|---|---|---|
| Total Count (default) | An absolute number (e.g., 120) | Stored directly as the patient target |
| Rate / Site / Month | A decimal rate (e.g., 1.5) | Calculated as: rate x number of sites x number of months |
When switching between modes, Prognosis preserves or back-calculates values automatically. The toggle is hidden when the recruitment pattern is set to Monthly Breakdown.
Recruitment Patterns
Choose how patients are distributed over the enrollment window for each country or region:
| Pattern | Description | Best For |
|---|---|---|
| Standard Bell Curve | Ramps up, peaks in the middle, tapers off | Most trials — realistic enrollment shape |
| Slow Bell Curve | Peak shifted later — slower ramp-up | Trials with slow site activation |
| Fast Bell Curve | Peak shifted earlier — faster ramp-up | Trials with aggressive early enrollment |
| Linear | Even distribution across all months | Simple forecasts, early planning |
| Monthly Breakdown | Exact patient counts per month | Maximum control with detailed plans |
Bell Curve Options
After selecting a bell-curve preset, a Recruitment Intensity Slider (range 0.5-1.5) lets you fine-tune the curve shape. A live visualization updates as you adjust.
For more control, switch to the Spline Curve Editor — an interactive chart where you click to add control points and drag them to shape the distribution. You can add, drag, and delete control points, and hover to see estimated patients per month.
Monthly Breakdown
When selected, a grid of month cells appears organized by year. Features include:
- Generate Grid from Dates — Creates month rows from your FPI/LPI dates
- Fill All / Fill Year — Batch-fill months with a single value
- Delete All / Delete Year — Clear monthly data
- Past months are disabled — use Step 8 (Actuals) for historical data
- Total patient count is auto-calculated as the sum of monthly values
Copy Configuration
To save time when multiple countries share similar settings, you can copy a country's configuration (dates, patient counts, recruitment pattern, and curve settings) to one or more target countries.
Validation
Fields with errors show red outlines and inline error messages.
| Field | Rule |
|---|---|
| Target patient count | Must be between 1 and 99,999 |
| First Patient In date | Required, must be a valid date |
| Last Patient In date | Required, must be after First Patient In |
| Screen failure percentage | Must be between 0% and 100% (Screened mode only) |
| Monthly breakdown | At least one month must have data |
| Recruitment intensity | Must be between 0.5 and 1.5 |
| Spline control points | Each point's x and y must be between 0 and 1 |
Regional Mode Additional Validation
- All countries must be assigned to a region
- All regions must have at least one country
The Continue button is disabled until all required fields are filled and no validation errors exist.
Auto-Save
Changes are saved automatically 1.5 seconds after you stop editing. A save status banner shows whether changes are saving, saved, or if an error occurred.
Mode Switching Behavior
| Switching From | What Gets Cleared | Confirmation Required? |
|---|---|---|
| Enrollment -> Screened | Nothing (fields are added) | No |
| Enrollment -> Regional | Nothing (panels are added) | No |
| Screened -> Enrollment | Screen failure percentages | Yes |
| Screened -> Regional | Screen failure percentages | Yes |
| Regional -> Enrollment | Region assignments and records | Yes |
| Regional -> Screened | Region assignments and records | Yes |
Tips
- Start with Enrollment mode. Switch to Screened only with reliable screen failure data, and Regional only for large multi-region trials.
- Bell curves are the most realistic enrollment shape for most trials — they account for natural ramp-up and taper.
- Do not confuse forecasted enrollment with actuals. This step captures your plan. Enter real data in Step 8.
- Drop-out rates are separate. Recruitment covers how many patients enter your trial. Drop-out rates are configured in Steps 5 and 6.