Head of Clinical Strategy, AG Mednet
These three case studies form a progression with consistent results across all three.
Enrollment triggers require rapid action, eligibility windows are narrow, and inclusion/exclusion criteria can be both complex and subjective — all of which creates variability in patient eligibility decisions. Enrolling a patient who does not qualify is an important protocol deviation that puts data integrity, trial timelines, and patient safety at risk.
To prevent enrollment errors, sponsors need a reliable method that ensures compliance and standardized decision-making. Centralized eligibility review is a highly effective solution that is increasingly implemented across the industry.
The tangible impact of centralized eligibility review is quantified across numerous trials — and the trial performance indicators and quality metrics speak for themselves, demonstrating strong ROI. As illustrated by the three case studies discussed below, centralized eligibility review works across therapeutic areas and indications — regardless of trial size, eligibility window, geographic location or requirement complexity.
The operational complexity goes up at every step. The pattern in the results does not.
Case Study One: 800-patient US-based sickle cell trial, seven-day window
Challenge: This trial enrolling 800 patients required each eligibility decision to be finalized within seven days of a clinical trigger. Due to concerns around the complexity and subjectivity of the protocol's inclusion/exclusion criteria, the sponsor was using centralized eligibility review from the start — but initially, the process was manual. The sponsor was gathering data from several systems by hand, forwarding it separately to eligibility reviewers and reconciling progress in spreadsheets. Reviewers had to work through EDC entries, lab results, and physician notes. Eligibility reviews were taking anywhere from 15 to 22 days — and enrollment milestones were falling behind as a result.
Solution: Moving the workflow into a single online review platform, with all relevant data in one place, expedited the entire process and let reviewers complete eligibility decisions within the seven-day window.
Process performance indicators: 100% of eligibility decisions were made inside the seven-day window after implementing the online workflow solution. Enrollment targets stayed on track throughout the trial, and there were 0 enrollment-based protocol deviations.
Quality metric: Centralized eligibility review identified 28 patients (3.5% of the overall enrollment target) who did not qualify for enrollment.
This study -- the simpliest of the three -- clearly demonstrates that the decision to move from a manual to an online workflow significantly optimized the centralized eligibility review process and overall study performance. It also demonstrates the value of centralized eligibility review: complete elimination of enrollment-based protocol deviations, by catching patients who are ineligible prior to enrollment.
Case Study Two: 125-patient US-based lupus trial, three-day window
Challenge: This trial enrolling 125 patients required eligibility decisions within three days — about half the window of the first case study. The sponsor recognized the need to standardize enrollment decisions across complex and subjective inclusion/exclusion criteria but had a concern that adding a centralized review step could slow enrollment. To address this, they elected to use an online centralized eligibility review workflow from the start. Like the first case study, eligibility review included EDC entries, lab results, and physician notes — with one additional complexity: calculation of specific indices based on multiple underlying values.
Solution: The online workflow brought everything together for the study team and the reviewers. Along with the patient records, pre-calculated indices were included in each eligibility package. Standardizing this particular content ensured that the indices were accurate, and the automatic calculations saved the reviewers considerable time and effort to generate them by hand.
Process performance indicators: 87% of eligibility decisions were made inside the three-day window, with only four patients falling outside it. Enrollment targets stayed on track throughout the trial, and there were 0 enrollment-based protocol deviations.
Quality metric: Centralized eligibility review identified 27 patients (21.6% of the overall enrollment target) who did not qualify for enrollment.
In this second case study, the window was half as wide, the data more complex — and centralized review still kept enrollment on track and caught more than one in five ineligible patients put forward for enrollment.
Case Study Three: 1,600-patient global cardiopulmonary outcomes trial, three-day window
Challenge: This trial enrolling 1,600 patients across 23 countries required the same three-day window as the second case study — but at ten times the scale and with a new layer of operational complexity. The sponsor recognized the importance of standardizing enrollment decisions globally while still achieving rapid eligibility decisions, and elected to use a centralized eligibility committee and online workflow from the start. Like the first two case studies, eligibility review included EDC entries, lab results, and physician notes. Unlike them, the sponsor of this global study had concerns about whether non-US sites would agree to provide patient records online. In addition to the high volume of non-English clinical documentation requiring expedited translation, eligibility reviews also required the collection of index CT scans for every case.
Solution: The online review platform provided a single unified workspace for every participant to collaborate in the global, multi-organization workflow. The platform is 21 CFR Part 11, HIPAA, and GDPR compliant — giving non-US sites the confidence to provide patient records online. It also supports DICOM upload, accommodating CT scan collection alongside source documents. Sites used the platform's redaction tools, to ensure PHI/PII was properly anonymized across all source documents and images before submission, and the study team used the platform’s translation vendor integration to obtain timely translations across languages.
Process performance indicators: Despite the larger scale and increased complexity of this study, the average cycle time across all eligibility decisions was only 2.1 calendar days — well within the three-day requirement. 94% of decisions were made inside this tight window, with 102 patients falling outside it. Enrollment targets stayed on track, and there were 0 enrollment-based protocol deviations.
Quality metric: Centralized eligibility review identified 307 patients (19.2% of the overall enrollment target) who did not qualify for enrollment.
With 23 countries, collection of patient records and CT scans, as well as expedited translations the complexity for this study was notably high — and yet the centralized eligibility review performance metrics the study team achieved were strong across the board. Once again, the review process caught nearly one in five patients who did not qualify for enrollment. The platform absorbed the complexity. The pattern held.
The story these case studies tell
Across all three trials, enrollment milestones stayed on track — with centralized eligibility review in place throughout. In every case, the system-driven workflow enabled high cycle time compliance — with 87% or more of eligibility decisions completed inside narrow three-to-seven day windows, across trials of increasing complexity. And in every case, centralized review caught a significant number of ineligible patients, preventing 100% of the important protocol deviations that would have resulted from their enrollment.
It is noteworthy that, had there been no centralized eligibility committee in place, all of these patients could have been incorrectly enrolled into these trials. If this had happened, the collateral damage would have been high. With an unacceptably large number of important protocol deviations, the study teams would need to institute reactive measures – that is, if they were able to discover the enrollment errors in time. Teams facing this exact situation have incurred a compounding negative impact to their trials – increased patient safety risks that can not be mitigated, data integrity and regulatory acceptance that have both been jeopardized, the high cost of replacing each incorrectly enrolled patient, and the significant study delays associated with re-starting enrollment later in a trial.
The harder the trial, the more there is to get wrong at the eligibility step. An online workflow for the centralized eligibility review process absorbs that complexity, delivering consistent high performance every time – protecting patient safety and data integrity, while making sure that enrollment stays on track and that 100% of enrolled patients will count in your final study analyses.
Key takeaways
- Centralized eligibility review works across therapeutic areas, trial sizes, and levels of operational complexity — without slowing enrollment.
- A system-driven workflow delivers the cycle time compliance needed to meet tight eligibility windows, even at global scale.
- The FDA guidance on Protocol Deviations emphasizes quality-by-design solutions to prevent important deviations, including incorrect enrollment. Centralized eligibility review is one proven answer.
For more on how teams design eligibility workflows in practice, watch our recent webinar, "How to reduce eligibility risk and prevent protocol deviations."
Catherine Tyner, Head of Clinical Strategy, AG Mednet. Driving value jointly created with new and existing CROs, sponsors, core labs, and AROs, Cathy brings decades of clinical research experience with a focus on Oversight Group Management for Clinical Endpoint Committees, DMCs, and other operations.
