Case Study
Reviewed by: Dr. Katharina Mohr, Project Manager / Team Lead GCP-Service West, GCP-Service International. & Dr. Andreas Beust, CEO, GCP-Service International
Date: 05.10.2026
Introduction:
Conducting oncology clinical trials in high-risk myelodysplastic syndromes (MDS) and acute myeloid leukemia (AML) is operationally demanding. Patients may have complex medical needs and limited treatment options, while study teams must manage stringent eligibility requirements, recruitment challenges, and high standards for patient safety and data quality.
The IMpress study, a Phase II clinical trial evaluating the efficacy and safety of IMetelstat in patients with high-risk MDS or AML failing HMA-based therapy, illustrates these challenges in practice. Conducted across 11 sites in Germany, France, and Australia, the study provides practical lessons in recruitment, study execution, and clinical oversight for complex hemato-oncology research.
Background: Conducting Research in a Highly Complex Patient Population
The IMpress study focused on patients with high-risk MDS or AML who had failed HMA-based therapy. These patients often had multiple comorbidities and limited remaining treatment options, making trial participation particularly important but operationally complex.
Eligibility was not determined by diagnosis alone. Patients had to meet specific disease assessment criteria and detailed laboratory requirements before enrollment. This required strong site expertise, clear communication, and close coordination among clinical and operational stakeholders.
The Challenge
Complex Eligibility, Laboratory, and Disease Assessment Requirements
One of the main recruitment challenges was identifying patients who met the study’s extensive eligibility criteria. Screening required detailed clinical and laboratory assessment, increasing the complexity of enrollment at site level.
Successful recruitment therefore depended on more than access to the right patient population. Investigators and study coordinators needed a clear understanding of the protocol and consistent processes for assessing potential participants. This made experienced MDS centers and sustained site engagement particularly important.
Treatment Continuation Beyond Database Lock
A separate operational challenge involved patients who continued to benefit from study treatment after database lock. Supporting these patients required planning for the transition to commercial supply, continued safety follow-up, dedicated reporting, and appropriate oversight of investigational medicinal product management.
This experience highlighted that, in some oncology clinical trials, operational responsibilities can extend beyond conventional study milestones. Treatment continuity needs to be considered as part of study planning when patients may still benefit from therapy.
Our Approach
A Targeted Recruitment Strategy
To address recruitment challenges, the study team focused on experienced MDS centers with access to the target population and established hematology networks. The local EMSCO representatives from Germany and France as well as ALLG in Australia supported collaboration among participating centers to exchange experiences in patient enrollment and study logistics.
Recruitment performance was monitored continuously, allowing the team to identify opportunities for improvement, maintain site engagement, and respond when enrollment momentum changed. The approach combined therapeutic expertise, established site relationships, and ongoing performance visibility rather than relying on a single recruitment intervention.
Strong International Project Coordination
Because the study involved multiple countries and regulatory environments, consistent coordination across the global study team was essential. Cross-functional collaboration supported protocol amendments, regulatory requirements, study execution, and close-out activities while maintaining alignment between sites and the sponsor.
Clear communication and shared operational visibility helped maintain consistency across the multinational study and supported effective implementation of changes throughout the study lifecycle.
Results and Impact
Rapid Recruitment Recovery Following Interim Analysis
One of the most notable outcomes was the recovery of recruitment momentum following the interim analysis. Restarting enrollment required more than simply reactivating sites. The study team implemented an updated protocol, retrained participating sites on the revised requirements, and reactivated sites to ensure they were prepared to resume screening and enrollment.
Combined with focused site engagement and close performance monitoring, this coordinated approach enabled the study to enroll an additional 23 patients within approximately less than four months.
The experience demonstrates that recruitment recovery in difficult-to-enroll oncology studies can depend on aligning protocol implementation, site retraining, site reactivation, and active performance management. Addressing these elements together helped create the conditions for renewed recruitment momentum.
Proactive Medical Oversight Through ClinSight®
The study also benefited from proactive medical oversight through ClinSight®, an application developed through a collaboration lead by GCP-Service International. Designed to support medical monitoring of patient safety and data integrity throughout clinical trials, ClinSight® provides an interactive overview of patient data, including timelines connecting clinical procedures and treatments with adverse events and visualizations of relevant data patterns over time.
In the IMpress study, ClinSight® supported proactive medical oversight by enabling review of safety, laboratory, and efficacy data trends during study conduct. This increased visibility into patient status and potential issues, demonstrating how centralized monitoring can complement traditional clinical trial monitoring approaches in complex oncology research.
Conclusion
The IMpress study illustrates that complex oncology clinical trials require more than a strong protocol and experienced sites. Recruitment strategy, protocol implementation, site readiness, and proactive oversight need to work together to respond effectively when study conditions change.
For sponsors conducting MDS, AML, or other challenging oncology clinical trials, these experiences highlight the importance of operational flexibility, strong site relationships, and coordinated study management throughout the trial lifecycle.
GCP-Service brings this practical experience to complex oncology research, supporting sponsors with the clinical and operational expertise needed to navigate challenging studies from planning through execution.
