Clinical trials often evolve during the study—protocols may need to be amended, inclusion/exclusion criteria adjusted, or new sites added to achieve enrollment on schedule. However, the biggest changes happen outside of the protocol...
This Precision for Medicine case study focuses on a promising therapy for advanced unresectable solid tumors. Originally initiated in 2015, the study faced significant challenges due to the performance of the initial CRO, which led to a transition to Precision in 2020—but the changes didn’t stop there. The challenges were further compounded when the original sponsor sold the drug to another company, necessitating a second transition—a double rescue.
What is a double rescue study?
In a double rescue study both the CRO and Sponsor change mid-trial.
In this trial, the first transition was between CROs. The previous CRO had issues managing the study effectively. Issues included protocol deviations, mismanagement of clinical trial processes, and inadequate data handling. Precision was brought in to rescue the study, which involved taking over not just the operational aspects but also addressing legacy issues.
The second rescue occurred when the original sponsor divested the drug to a new sponsor. This added another layer of complexity, requiring Precision to manage not only the handover but also the expectations of a new sponsor who inherited an already troubled study.
Overcoming operational challenges in a double rescue study
Precision successfully navigated the compound transitions, ensuring data integrity, patient safety, and operational continuity.
Transition complexity multiplied
The initial transition from the previous CRO was fraught with challenges, including the need to address legacy protocol deviations, inconsistent data handling, and gaps in communication.
The second transition, due to the sponsor change, required recalibrating operational strategies, renegotiating site contracts, and adjusting study timelines to align with the new sponsor’s objectives.
Data management across databases
One of the most significant challenges was the management of dual databases—one from the legacy CRO and a new database set up by Precision. The situation was complicated further by the need to transfer data only for active patients while archiving data for inactive patients.
Protocol adjustments and monitoring
As the study evolved from a phase one dose-finding trial focused on safety to include efficacy, new challenges emerged. This evolution necessitated changes to the Statistical Analysis Plan (SAP) and increased focus on data outputs with efficacy components.
Differing sponsor requirements
The sponsor transition brought its own set of challenges, particularly in managing expectations and ensuring continuity. The new sponsor had different operational standards and priorities, which necessitated realignment across multiple functions.
The operational continuity of the study was threatened by the sponsor change, which impacted various elements such as site contracts, labeling, and patient communications.
Communication and collaboration
Given the multiple transitions and complex data management requirements, communication and collaboration were critical to the success of this double rescue. The frequent changes in team members, both internally and on the sponsor side, added to the challenges.
Precision successfully completed the double rescue study
Having stabilized the study and ensured all critical milestones were met, the project remained on track for a closeout, with all active patients having completed their transitions smoothly.
Precision implemented a phased transition approach
The first phase focused on stabilizing ongoing operations, which involved immediate data reconciliation and rectifying protocol deviations. The second phase targeted aligning the study’s strategic direction with the new sponsor’s goals, which involved re-engaging sites, updating patient communication protocols, and re-initiating patient enrollment under the new guidelines.
Precision’s data management team took a systematic approach to merge the legacy data with the new system. This involved extensive manual processes, including the development of creative programming solutions for data migration. A specialized patient tracker was created to monitor each patient’s status, ensuring no data was lost during the transfer. The team also conducted a thorough data cleaning process to address discrepancies and ensure CDISC compliance.
Precision also worked closely with biostatistics and medical writing teams to revise the SAP and prepare for more complex data analysis. The study also adopted a 100% Source Data Verification (SDV) approach, requiring additional Clinical Site Associates (CSAs) to manage the increased workload. This ensured that data quality remained high despite the operational upheavals.
Managing the relationship with our Sponsor partner
Precision employed a strategic communication plan to manage the sponsor relationship. This included regular update meetings, detailed progress reports, and a transparent approach to discussing the inherited challenges. The team focused on building trust with the new sponsor by demonstrating their capability to manage complex transitions and deliver quality outcomes.
Precision established a cross-functional task force to manage the operational aspects of the sponsor transition. This team was responsible for renegotiating contracts, re-establishing site relationships, and ensuring that patient communication was consistent across the board. Additionally, the team managed the operational impact on labeling and investigational product distribution, ensuring that the transition did not delay patient treatments.
Solution-oriented collaboration
Precision’s project management team implemented a robust communication strategy. Weekly cross-functional meetings ensured alignment, while targeted gap analyses helped identify immediate action items. The emphasis was on solution-oriented discussions rather than assigning blame, fostering a collaborative environment even under challenging circumstances.
Precision's role in the double rescue study
Effectively managing a double rescue study requires precision and teamwork. Both within the CRO and with each Sponsor, data management is critical, but so is communication.
Despite the dual database challenge, Precision maintained data integrity throughout the transitions. The team’s efforts in data reconciliation and CDISC compliance ensured that the data remained robust and reliable, even as the study evolved to include efficacy assessments.
Putting Sponsor satisfaction above all
The new sponsor expressed satisfaction with the way Precision managed the transition, particularly appreciating the transparency and proactive communication. The sponsor’s confidence in Precision led to further collaboration on additional studies.
The team received recognition for their efforts in managing the complex transitions and maintaining the study’s momentum. An extension study initiated in 2023 further highlights the study’s continued relevance, with new patients being successfully enrolled.
Capable teams that move with precision
Precision’s handling of this double rescue underscores the organization’s expertise in managing highly complex clinical trials, even under challenging conditions. Through a combination of strategic planning, robust data management, and strong stakeholder communication, Precision not only salvaged a troubled study but also set it on a path to successful completion.
Precision's commitment is to deliver excellence, regardless of the obstacles.
