The Study Rescue War-Room Pack

Rescue Mode Creates Noise.

When a study enters rescue mode, every function usually sees a different problem.

Recruitment says:

“We need more candidates.”

Sites say:

“The protocol is too difficult.”

Coordinators say:

“The candidates are poor quality.”

Data teams say:

“We are missing source information.”

Patients say: “Participation is too difficult.”

Finance says:

“The payment workflow is manual.”

Sponsors say:

“Enrollment is behind.”

All of those observations may be valid.

But they do not all have equal impact on the actual enrollment constraint.

The first rescue meeting should therefore not begin with:

“What else can we do?”

It should begin with:

“Where exactly are viable participants getting stuck?”

5. The Core Rescue Principle

Do not optimize everything at once.

A useful rescue process identifies:

1. where the participant journey is slowing, 2. whether the constraint is upstream or downstream, 3. whether the constraint is volume, conversion, timing, or burden, 4. what evidence supports the diagnosis, 5. which intervention can change the bottleneck fastest.

The War-Room Pack is built around that sequence.

6. War-Room Question 1 Where Are Candidates Actually Dropping?

Map the journey:

Candidate identified

→ Candidate reviewed

→ Contacted

→ Pre-screened

→ Likely eligible

→ Consented

→ Screened

→ Randomized

→ Milestone completed

→ Paid

For every transition ask:

how many enter?
how many progress?
how many drop?
how long do they wait?
who owns the transition?
why do they fail?

Rescue red flag

The team knows enrollment totals but cannot reconstruct the participant funnel.

Rescue output

Participant Journey Drop-Off Map

7. War-Room Question 2

Do We Have a Patient-Supply Problem or a Conversion Problem? This is the most important distinction in the rescue meeting.

Supply problem

Not enough plausible candidates are entering the funnel.

Possible fixes:

additional recruitment channels,
more referrals,
provider partnerships,
geographic expansion,
additional sites.

Conversion problem

Enough candidates exist, but too few become randomized.

Possible fixes:

better matching,
better pre-screening,
faster site follow-up,
better source-data access,
consent improvements,
participant-burden reduction.

Rescue red flag

The study responds to weak randomization by increasing candidate volume without measuring candidate quality.

Rescue output

Supply vs Conversion Classification

8. War-Room Question 3

Why Are Screens Failing?

Do not report:

“Screen failure = 42%.”

Break it down. Categories

True clinical ineligibility

Missing medical evidence

Protocol interpretation

Timing/window failure

Medication conflict

Biomarker mismatch

Participant refusal

Travel/logistical burden

Consent friction

Operational delay

Ask

Which failures could have been identified earlier?

Which failures cluster at particular sites?

Which failures are repeating week after week?

Rescue red flag

A high percentage of screening effort is spent discovering information that could have been known before the formal screen.

Rescue output

Screen-Failure Root-Cause Map

9. War-Room Question 4

Are Good Candidates Waiting Too Long for the Next Action?

Measure median time: candidate identified → reviewed

reviewed → contacted

contacted → pre-screened

likely eligible → consented

consented → screened

screened → randomized

Ask

Where is the longest queue?

Who owns it?

What happens when the responsible person is unavailable?

Does the system generate an action automatically?

Are coordinators checking multiple systems?

Rescue red flag

The participant is viable, but momentum is lost because the next action is manual or unclear.

Rescue output

Handoff Latency Map

10. War-Room Question 5

Are We Advancing the Wrong Candidates?

A large funnel can hide poor recruitment economics.

Ask:

Which source generates the best randomized-patient yield?
Which source generates the most screen failures?
Which source consumes the most coordinator time?
Are sites prioritizing candidate volume or candidate probability?
Can likely eligibility be inferred before coordinator review? Rescue red flag

A recruitment source is celebrated for generating large lead volume even though very few become randomized participants.

Rescue output

Candidate Source Yield Matrix

11. War-Room Question 6

Is Missing Clinical Evidence Slowing Eligibility Decisions?

For oncology, rare disease, CNS, and other complex studies, the right patient may exist but the evidence may not be available.

Common missing items:

prior labs,
imaging,
pathology,
genomics,
medication history,
treatment history,
specialist notes,
disease-stage information,
longitudinal records.

Ask

Can the site retrieve this evidence efficiently?

Is the patient asked to obtain records?

Are coordinators chasing other providers?

Are PDFs manually transferred?

Are tests repeated because evidence cannot be found?

Rescue red flag A potentially eligible candidate stalls because the team cannot verify something already known somewhere else.

Rescue output

Eligibility Evidence Gap Map

12. War-Room Question 7

Is Consent a Legal Artifact or an Operational Workflow?

Ask:

Can the team immediately see whether consent exists?
Can the team see what the patient actually consented to?
Can permissions be interpreted consistently?
Is re-consent required?
Does consent status align with source-data access?
Does withdrawal propagate operationally?

Rescue red flag

Consent exists in one system, but operational teams still need manual clarification before progressing the patient.

Rescue output

Consent & Permission Friction Map

13. War-Room Question 8

Is the Study Asking Too Much of the Participant?

A clinically eligible participant can still be operationally unsuitable.

Measure:

visit count,
travel distance,
time away from work,
childcare burden,
parking,
accommodation,
remote tasks,
device requirements,
questionnaires,
reimbursement requirements,
out-of-pocket costs.

Ask

Which burden creates the most refusals?

Does that vary by geography?

Can any burden be shifted away from the participant?

Rescue red flag

Patient refusal is recorded without systematically capturing the real reason.

Rescue output

Participant Burden Map

14. War-Room Question 9

Is Payment or Reimbursement Creating Friction?

Map:

Milestone completed

→ Completion verified

→ Payment approved

→ Exception resolved

→ Payment issued

→ Participant notified

Ask How long does this take?

Does the patient finance travel first?

Who handles exceptions?

How much site time is spent on payment questions?

Can the participant see payment status?

Rescue red flag

The payment provider is fast, but internal milestone approval is slow.

Rescue output

Milestone-to-Payment Map

15. War-Room Question 10

What Is the Single Constraint We Will Fix First?

At the end of the rescue meeting, choose one primary constraint.

Not seven.

Not twelve.

One.

Possible classifications:

A. Patient Supply

B. Candidate Match Quality

C. Site Response / Throughput

D. Screen Failure

E. Missing Eligibility Evidence

F. Consent / Permission G. Participant Burden

H. Payment / Reimbursement

I. Cross-System Handoff

Then define:

baseline metric,
intervention,
accountable owner,
review date,
success threshold.

Rescue red flag

The rescue plan contains dozens of activities but no clearly stated bottleneck.

Rescue output

One-Constraint Recovery Plan

16. The Rescue Constraint Tree

Start here:

Are enough plausible candidates entering?

No → Patient supply problem

Yes → Continue

Are enough candidates likely eligible?

No → Match-quality / protocol interpretation problem

Yes → Continue

Are likely eligible candidates progressing quickly? No → Site/handoff problem

Yes → Continue

Are formal screens passing?

No → Screen-failure / evidence problem

Yes → Continue

Are eligible participants consenting and continuing?

No → Consent / burden problem

Yes → Continue

Are participant milestones completed and supported smoothly?

No → Participation / payment problem

17. Rescue War-Room Agenda

60-Minute Meeting Structure

Minute 0–5

State one objective:

“Identify the primary constraint limiting randomized enrollment.”

Do not begin with proposed solutions.

Minute 5–15

Review enrollment funnel. Where is the largest drop?

Where is the longest delay?

Minute 15–25

Review candidate-source quality and screen-failure reasons.

Minute 25–35

Review site response and handoff latency.

Minute 35–45

Review data, consent, participant burden, and payment friction.

Minute 45–55

Select primary constraint.

Minute 55–60

Define:

one action,
one owner,
one metric,
one review date.

18. Rescue Dashboard

Track only the metrics needed to understand the constraint.

Core metrics Candidates identified/week

Pre-screen pass rate

Screen-failure rate

Randomized/week

Median identification → outreach time

Median likely eligible → screening time

Participant refusal rate

Milestone → payment time

Optional

Coordinator hours per randomized patient

Site-level conversion

Candidate yield by source

Missing-evidence rate

19. Stop / Continue / Start Framework

STOP

Activities that increase workload without evidence they address the bottleneck.

Examples:

indiscriminate candidate volume,
unnecessary reporting,
opening sites before diagnosing conversion,
duplicative manual reconciliation.

CONTINUE

Activities with evidence of strong randomized-patient yield. Examples:

high-converting referral sources,
productive sites,
efficient outreach methods.

START

The specific intervention that attacks the identified constraint.

A Rescue Plan Should Reduce the Constraint — Not Just Increase Activity.

Use the War-Room Pack to structure your next enrollment-recovery discussion around evidence instead of assumptions.

Download includes

10-question rescue diagnostic
Constraint tree
60-minute war-room agenda
Screen-failure map
Site latency worksheet
Participant burden worksheet
One-Constraint Recovery Plan

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