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Suggested parameters and sets of instructions outlining best practices and standards for accomplishing specific duties.
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
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Careful review of study protocol requirements
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For multi-site studies
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Prior experience
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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
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Review the monthly department/division portfolio reports carefully.
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
Discuss who will be responsible for financial deficit: department/division vs PI? |
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
Questions?
Email [email protected]
Clinical Trials Support Office
2800 Plymouth Rd, Building 520, Ann Arbor, MI 48109
Edited by: [email protected]
Last updated: March 25, 2025 12:24 PM