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Guidance
Suggested parameters and sets of instructions outlining best practices and standards for accomplishing specific duties.

This Copy Was Generated On: June 16, 2026

Clinical Trials with No/Low Enrollment: Guide for Departments

CTSO

| Approval Date:

March 25, 2025 12:00 pm

Background

Successful enrollment of clinical trials can be challenging for various reasons.
When studies do not meet target enrollment, departments may experience financial loss and negative impact on site and PI reputation.
To prevent financial loss, departments may consider standard measures to avoid and manage no/low enrollment trials.
This document may serve as a guide to individual departments/divisions who wishes to create standard operating procedures (SOPs) around clinical trials with no/low enrollment.

Prevention: Perform a Feasibility Review to Avoid No/Low Enrollment Trials

Careful study selection:

The department, along with the PI and other applicable staff, should review study benefits vs. demand prior to committing to a study as a site/investigator. Below are considerations specifically related to patient enrollment. Examples of Pros and Cons may help review the balance of activity.

Considerations	Examples (Pros & Cons)
Potential benefits Direct health benefit to patients Improved reputation of PI/division/department to bring in future trials	There is great potential for the drug/device to be effective.
Careful review of study protocol requirements Would patients want to participate based on the study duration, visit frequency and procedures, chance of receiving study intervention/drug, potential benefits vs. risks, etc.? Based on the eligibility criteria, is the current patient population fit for the study? Could we recruit additional patients from the community? Are there competing trials within the department?	There is a high chance of receiving placebo and no chance of crossing over to receive active drug. Patients will be compliant and motivated because the study visits are at a manageable frequency, and all patients will eventually receive treatment. Patients must put aside an entire day for each study visit because multiple pharmacokinetic blood draws are needed throughout the day. Patients seen in the clinic with the disease of interest may not meet eligibility criteria because they are too strict, excluding patients with comorbidities and lab abnormalities. Patients can be recruited from a local community group for the disease of interest. We already have an actively enrolling study for this rare disease of interest, and we don’t want to take away from the existing study.
For multi-site studies How competitive is site selection and patient enrollment? What is the timeline of expected start-up and enrollment?	There are many other sites, including private practices, that will be performing the trial, leading to short start-up or recruitment times, so we may have a difficult time recruiting the target enrollment number. The sponsors are expecting sites to start recruiting 3 months from now, but it will likely take us longer to be ready for enrollment.
Prior experience What has prior experience been with this sponsor?	Last time we worked with this sponsor, budget negotiations and CTA execution went smoothly. Last time we worked with this sponsor, they did not accept our informed consent document boilerplate language regarding subject injury.

During study planning:

The department, along with the PI and other applicable staff, should actively participate in the conversation with the CTSU to confirm appropriateness of pursuing the trial during the start-up processes. Below are considerations specifically related to patient enrollment that could impact the feasibility of moving forward to contract execution:

Pre-award finance meeting – development of a draft budget
- Provide realistic target enrollment number, as study payments are based on enrollment number
- Provide accurate effort for all study staff
- If significant effort is anticipated to pre-screen patients to meet enrollment goal, consider budgeting for pre-screening activities such as database or chart reviews.
- If enrollment is expected to be difficult, pre-award and contracting should explore if the sponsor will allow the trial to terminate early with no accrual (even with screen fails) to avoid ongoing study maintenance charges.
Participate in regular (weekly/bi-weekly) check-ins with portfolio manager to ensure timely completion of budget negotiations, CTA execution, etc.
- If there are delays that may prohibit the study from starting on time, consider abandonment earlier than later.
- If there are delays that may shorten the enrollment period than initially anticipated, consider abandonment earlier than later or amend the target enrollment number and subsequently the budget (although this may again delay study start-up).

Management: Track Active No/Low Enrollment Trials

When the study is open to accrual: Recommend regular evaluation of study progress to ensure appropriate accrual.

The below table outlines measures taken by CTSU to monitor the progress of all trials and what departments may pursue with the information provided regarding no/low enrollment trials.

CTSU Measures In Place

Department and Study Team Actions

Pre-Award Internal Budgets are created showing projected balance at 25%, 50%, and 100% enrollment

Monthly department/division portfolio reports reflect projected and actual enrollment to be reviewed by PI and Department.

At CTSU post-award quarterly meetings

Financial status of all studies will be reviewed, and no/low enrollment trials will be highlighted.
Potential financial impact (projected deficit) of a no/low enrollment trial can be provided if team is considering closing a trial

Review the monthly department/division portfolio reports carefully.

Identify no enrollment studies that are past the 25% projected enrollment timeline
Identify low enrollment studies that are past the 50% projected enrollment timeline.

Actively engage PIs and review reasons for no/low enrollment

Review barriers to sufficient enrollment and how to overcome them.

Review risks vs benefits of continuing the trial vs abandoning the trials

Keep in mind: Sponsors may require low enrolling trials to remain open. Cost savings may only be possible if closing no enrollment studies.

Discuss who will be responsible for financial deficit: department/division vs PI?

Guidance for Reviewing the Low or No Enrollment Clinical Trials Report

Purpose
To help departments identify and address clinical trials with low or no enrollment to prevent financial losses and ensure efficient use of resources.

Data Dictionary
Each report field provides insight into trial performance. Please see appendix.

Key Areas to Review

Scenario	Recommended Actions
>50% through accrual time period, 0 enrolled	Review immediately with PI, see below. Project could be a candidate for closure with the sponsor if there have not been any screen failures or subjects enrolled.
25–50% through accrual time period, 0 enrolled	While this could be a candidate for closure, the study may instead benefit from a PI/Project team action plan to address enrollment. After arriving at a plan with the team, monitor closely. If there is an enrollment or screen fail, the site is unlikely to be able to be closed.
<50% of expected accrual time period with Some enrolled	Monitor monthly; implement recruitment adjustments. If the overall recruitment number is no longer realistic, given the remaining duration period, ask CTSU if they have re-evaluated the budget to set realistic financial plans for the rest of the trial. A high number of screen failures could indicate a feasibility or protocol design issue.

Key Areas of Discussion with the PI/Project Team

Risk and Feasibility Assessment

Evaluate the trial’s scientific importance versus operational and financial risks.
Review recruitment barriers.
Discuss if it is still feasible to meet the enrollment goal.
Identify whether continued effort is justified.

Action Planning

Modify or enhance recruitment efforts (advertising, expanded sites, revised eligibility).
Please see the available MiChart Research Recruitment Services (level 2 login required)
Review impact of continued no or low enrollment with CTSU Post-Award. Discuss opportunities to renegotiate budget with the sponsor (i.e., timeline extension, recruitment support).
Close trial early if infeasible or financially unsustainable.
Reallocate resources to higher-performing studies if warranted.

Appendix: Data Dictionary

Field	Interpretation	Use for Decision-Making
Open to Accrual/Anticipated Close to Accrual Dates	Defines the trial’s anticipated enrollment window at the time of budgeting	Accrual duration is used in budgeting. It is used to determine the effort and expenses expected to occur during the enrollment period. Accrual duration is an estimate and can change from what is anticipated; however, the duration listed reflects what was used in budgeting. Accrual durations longer than budgeted (especially without accruals) will negatively impact the budget.
% Accrual Duration Completed	Indicates elapsed time vs. total accrual period	Used to assess progress against target enrollment
Earned Balance	Project balance, including revenue not yet received	Evaluates fiscal health and sustainability. Compared to the general ledger project balance, the earned balance includes revenue earned for protocol activities completed but not yet received.
3-Month Projection	Projected financials	Evaluates fiscal health and sustainability. Projects project balance based on last 3 months of expenses and anticipated revenue based on OnCore upcoming activity. If accrual is 0, there is no anticipated revenue from subject activity.
Target Accrual	Number of subjects that were budgeted to enroll	Establishes baseline for progress based on current activity (accrual & screen failures).
Actual Accrual	Number of subjects enrolled to date	Measures enrollment success.
Active Subjects	Participants still active in the study	Indicates ongoing engagement and assumes additional revenue is expected.
Screen Failures	Individuals who failed eligibility after consent	Screen failures indicate the study team has been actively trying to recruit.
Date of Most Recent Consented Subject	Last enrollment activity	Highlights potential resource issues or competing trials.

Evaluation and Next Steps for Abandoning No/Low Enrollment Trials

The following general guidelines can be used by departments and study teams to decide when to close a trial:

No patients screened and overall study has met enrollment goal -> CLOSE and REDUCE FINANCIAL LIABILITY
No screening after X months (e.g., after 50% of anticipated enrollment period) -> CLOSE and REDUCE FINANCIAL LIABILITY
Screening has occurred, but all failed to meet criteria for enrollment -> CLOSE; sponsor agreement may be required

If the decision is made to abandon a no/low enrollment trial, PI/study team should notify:

CTSU post-award personnel who will review sponsor and university requirements to initiate the close-out process
The sponsor, once obligations are known and considered

UNIT: Clinical Trials Support Office

TOPICS: Clinical Research / Clinical Trial

Questions?

Email [email protected]

Clinical Trials Support Office
2800 Plymouth Rd, Building 520, Ann Arbor, MI 48109

Edited by: [email protected]
Last updated: November 25, 2025 10:30 AM