Rescue trials
are among the most demanding in clinical research, requiring rapid onboarding, seamless transitions, and immediate impact. Precision was brought in to rescue a global Phase 3 study comparing XRd (study drug + lenalidomide + dexamethasone) versus Rd (lenalidomide + dexamethasone) in patients with relapsed multiple myeloma.
|
Study Type |
Phase 3 |
|
Therapeutic Area |
Oncology |
|
Indication |
Relapsed Multiple Myeloma |
|
Geography |
20 countries |
|
Sites |
>150 sites, >790 patients |
|
Precision’s Role |
Rescue trial management, global coordination, site engagement, and data quality oversight |
The study had already opened but planned to expand to 155 sites across 20 countries and enroll a target of 780. However, operational inconsistencies and site dissatisfaction threatened data quality and timelines.
Strategic Rescue Execution
Precision’s oncology team implemented a cohesive global strategy to stabilize and accelerate the trial. Key actions included:
- Development of comprehensive project plans to drive consistency across regions
- Implementation of Site Quality Metrics (SQMs) to monitor performance
- Alignment with the sponsor on project status, expectations, and communication strategy
- Clarification of roles and responsibilities across teams and systems
- Training on EDC systems and query generation using patient profiles
- Review and integration of essential regulatory documents and site-level data
- Updates to consent forms and contracts where applicable
This structured approach ensured that all stakeholders—from sites to sponsor—were aligned and empowered to execute.
Operational Impact and Outcomes
Following Precision’s intervention, the trial saw immediate improvements:
- High subject eligibility maintained across sites
- Preservation of the primary endpoint, ensuring statistical integrity
- High data quality through enhanced CRA oversight
- Drastic improvement in site satisfaction, attributed to experienced CRAs and streamlined communication
- Enrollment completed one month ahead of the corporate goal, a significant achievement for a rescue trial
These results validated Precision’s ability to not only recover a struggling study but elevate its performance beyond expectations.
Rescue of a Complex Myeloma Trial
Rescue trials require clarity, speed, and precision. Early alignment, transparent communication, and experienced teams are essential to turning around complex global studies.
Precision’s rescue of this multiple myeloma trial exemplifies the power of strategic planning, experienced personnel, and global coordination. The trial was stabilized, accelerated, and completed ahead of schedule—preserving scientific integrity and sponsor confidence.
