Device trial sites go cold and enrollment stalls without explanation | Healthcare & Life Sciences

What it costs you today

The site was enthusiastic in the kickoff. The clinical coordinator was engaged. Then enrollment slows, then stops, and the PI's replies become one-liners. You do not know if it is a patient population issue, a competing protocol, a staffing change, or something your team did. By the time you find out, you have lost two months of enrollment.

How RadRoot is used here

RadRoot sends the clinical coordinator a five-question adaptive check-in when enrollment drops below threshold for two consecutive months, framed as support outreach rather than a performance audit.

The file you would upload

A Medidata Rave CTMS - Site Enrollment Report export. One row is one clinical trial site enrollment record. RadRoot reads the whole row, so every question can name something the person already knows is true.

Site_ID	Site_Name	Principal_Investigator	Coordinator_Name	Coordinator_Email	Coordinator_Title	Protocol_Number
VT-1047	Northgate Regional Medical Center	Dr. Susan Patel	Jennifer Wu	jennifer.wu@northgate-medical.example.com	Senior Clinical Research Coordinator	VT-2024-CR-09
VT-1052	Riverside University Hospital	Dr. Marcus Chen	David Kowalski	david.kowalski@riverside-univ.example.com	Clinical Research Coordinator	VT-2024-CR-09
VT-1058	St. Catherine's Heart Institute	Dr. Rachel Hoffman	Maria Gonzalez	maria.gonzalez@stcatherines.example.org	Lead Research Coordinator	VT-2024-CR-09
VT-1061	Summit Valley Hospital	Dr. James Thornton	Angela Brooks	angela.brooks@summitvly.example.com	Clinical Research Coordinator	VT-2024-CR-09
VT-1065	Lakeside Health System	Dr. Peter Nam	Christopher Wells	christopher.wells@lakeside-health.example.com	Senior CRC	VT-2024-CR-09

First 5 of 20 rows, first 7 of 14 columns. RadRoot interviewed the clinical research coordinator on each row, and 9 of 20 answered.

One interview, exactly as it ran

Six options every time, including the ones that reflect badly on whoever sent it. Each question was written after the answer above it landed.

Q1Your site at Northgate Regional Medical Center enrolled only 4 of 25 targeted patients and the last enrollment was back on November 18th. What is the main reason enrollment has slowed?

·Competing trials have diverted most of our eligible patients
·The patient population we expected has not materialized in our clinic
✓A key team member who handled this protocol left the site
·Dr. Patel has reduced their time dedicated to this trial
·The sponsor paused enrollment to address a protocol amendment
·Institutional delays with consent forms have blocked screening

Q2When did that team member leave, and who has taken over their responsibilities for this protocol?

·Three months ago, and we still have not found a replacement
·Six weeks ago, and I have absorbed their responsibilities myself
·Two weeks ago, and we are sharing the work until someone is hired
✓About a month ago, and the new person is still learning the protocol details
·Last week, and the transition is just beginning now
·In early December, and the replacement is fully trained and ready

Q3Is Dr. Patel still committed to continuing the trial, or has their level of engagement changed?

·Dr. Patel has completely disengaged and is no longer referring patients
·Dr. Patel remains highly engaged and is actively screening patients
·Dr. Patel has delegated oversight to another physician who is less familiar with the trial
·Dr. Patel has expressed interest in withdrawing the site from the study
✓Dr. Patel is still supportive but is stretched across multiple priorities
·Dr. Patel recently increased engagement after a discussion with the sponsor

Q4Do you believe enrollment can restart in the next 30 days, or are there other obstacles in the way?

·No, the principal investigator has not committed to continuing enrollment
✓Yes, if we receive focused retraining on the protocol requirements
·Yes, we are ready to restart immediately with no additional support needed
·No, we need at least two months to stabilize staffing before we can restart
·Maybe, but only if the protocol requirements are simplified
·No, there are institutional compliance issues that must be resolved first

Q5Which aspect of the protocol does the new coordinator find most challenging to manage right now?

·The adverse event reporting timelines and documentation requirements
·The informed consent process and managing patient expectations
✓The patient eligibility screening and the imaging schedule requirements
·The device accountability logs and storage requirements
·The follow-up visit procedures and data entry into the EDC system
·The coordination with the cardiology lab for procedural visits

The verdict it produced

Written for whoever ran the campaign. The respondent never sees it.

The stall at Northgate Regional is entirely staffing-driven. The original coordinator left four weeks ago and the replacement is still learning the protocol, particularly eligibility screening and imaging schedules. Dr. Patel remains supportive but is stretched thin. The site is not at risk of withdrawal. A focused retraining session on screening criteria and scheduling would restart enrollment within 30 days. This is an operational gap, not a commitment issue.

coordinator turnover negative high confidence

The original coordinator who managed protocol training left the site approximately four weeks ago.

training gap negative high confidence

The replacement coordinator is not yet proficient in the protocol details and eligibility criteria.

site commitment mixed medium confidence

The PI remains supportive of the trial but is managing competing priorities.

enrollment risk positive medium confidence

Enrollment can resume within 30 days if focused retraining is provided.

protocol complexity negative medium confidence

Patient eligibility screening and imaging schedule requirements are the primary operational challenges.

See this on your own data

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