Brief · Use case · Clinical Operations
Trial Enrollment Recovery Plan.
LivePlanPlan the recovery of a Phase 3 trial behind on enrollment: milestones, owners, outside dependencies and the first move.
Trial Enrollment Recovery Plan is a ready-made use case for Clinical Operations. It ships under the Plan template.
For clinical operations leads re-baselining a trial. You get the objective and critical path first, the sequence with exit criteria, the dependencies you do not control, the pre-mortem and the first move. Durations are cited, marked as estimates or marked as gaps.
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The decision
What is the plan to recover a Phase 3 trial in moderate-to-severe atopic dermatitis whose enrollment is behind target, from diagnosis of the cause to a re-baselined timeline?
The steps of the plan
Recovery starts from a diagnosis of the cause, because the remedy depends on it. The plan sequences the steps and marks the ones that need a regulator or an ethics committee.
| Step | What it involves | The clock or source |
|---|---|---|
| Confirm the cause | Break enrollment down by site and month and identify where candidates are lost: screening, consent or randomization. | Your screening logs; no external clock. |
| Choose the remedy | Broaden eligibility, add or replace sites, or reduce the burden of participation. FDA’s guidance on diversity covers broadening eligibility criteria, enrollment practices and trial designs, and its guidance on decentralized elements covers carrying out activities away from traditional sites.1,2 | FDA guidance, final November 2020 and September 2024. |
| Amend and approve | Change the protocol where needed, and obtain the approvals each change requires from regulators and ethics committees. The plan names which changes need which approvals and does not invent their durations. | Authority and committee procedures; durations are gaps unless published. |
| Re-baseline | Reset the enrollment curve and the timeline on the new assumptions, with a trigger for the next review.3 | Quality and good clinical practice expectations for managing a trial. |
What the plan does
Diagnosis first. The plan begins where the Diagnosis template ends, with a stated cause. It says which remedy fits which cause, so a site problem is not treated with a protocol amendment.
Remedies with a regulator’s view. FDA’s November 2020 guidance sets out how eligibility criteria, enrollment practices and trial designs can be broadened to include more patients, and its September 2024 final guidance describes decentralized elements as trial activities carried out at locations other than traditional sites. The plan uses both as options and says which would need a protocol amendment.1,2
The current good clinical practice standard. ICH E6(R3) is the international good clinical practice guideline. The principles and Annex 1 were adopted on 6 January 2025, and Annex 2, on decentralised elements, pragmatic elements and real-world data, was adopted on 3 June 2026. The plan notes which parts apply to the change it proposes.3
How it could fail. The pre-mortem probes the failures this plan invites: a remedy that treats the wrong cause, an approval that takes longer than the plan assumed, competing trials that take the same patients, or a new site that activates late.
Recommended length
Comprehensive
Several parties are involved and decisions have to be taken along the way. Comprehensive adds the gates, the responsibility table and the risk map.
You can pick another length on the form. The other two stay available.
Assumptions the plan checks
The plan states the assumptions its dates rest on and says which one would move the finish if it failed. Examples for this plan:
- The diagnosed cause is the main one and the others are small.
- The approvals each change needs can run in parallel.
- The sites that remain can absorb the new target.
Standards, guidance and sources
Regulators and standards
The decision practice behind the memo itself is on the template page.
What gets flagged
Any approval duration the plan could not source, any remedy that depends on an unconfirmed cause, and any change whose approval route is unclear.
What arrives
- The objective
- The sequence
- Gates and decisions
- Who is needed
- Dependencies and external clocks
- What could derail it
- The first move
What it will not do
It does not promise dates. Each duration is sourced or marked as an estimate, and an unpublished deadline is a gap.
It does not decide whether to continue the trial, and it does not amend the protocol.
It does not guarantee the dates. The durations are sourced or marked as estimates, and the plan says which.
It does not invent an agency’s deadlines. A deadline that is not published is a gap.
It does not run the plan. It gives an owner the first move and the criteria for the next gate.
References
- [1] U.S. Food and Drug Administration. Enhancing the Diversity of Clinical Trial Populations — Eligibility Criteria, Enrollment Practices, and Trial Designs. Final guidance, November 2020. Title and date as given in FDA presentations and announcements; the guidance text was not read.
- [2] U.S. Food and Drug Administration. Conducting Clinical Trials With Decentralized Elements. Final guidance, September 2024. Docket FDA-2022-D-2870. Status and definition as given in FDA’s announcement and search excerpts; the guidance text was not read in full.
- [3] International Council for Harmonisation. ICH E6(R3): Guideline for good clinical practice. Principles and Annex 1 adopted 6 January 2025; Annex 2 adopted 3 June 2026. Dates as given in ICH and EMA listings found by search; EU effective dates are stated differently on EMA pages, so check the current page.
Links checked 9 October 2026
These are the sources the template drew on. None of their authors or issuers has reviewed it.
About the Brief service
A Brief is a written answer from one specialist, at the depth you asked for. It arrives with its sources, and it closes by saying plainly what would change the conclusion. Nothing is hidden behind a summary, and anything the expert could not source is marked as a gap rather than filled in.
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