Accelerated access to novel cancer therapies at Moores Cancer Center

Moores Cancer Center (MCC) is one of 57 National Cancer Institute (NCI) Designated Comprehensive Cancer Centers in the United States. NCI designations are reserved only for cancer centers that demonstrate the most rigorous standards and high performance in cancer research. MCC has a strong focus on clinical trials, including investigator-initiated trials (IITs), NCI cooperative group and commercial clinical trials and is positioned at the forefront of advancing science, expanding treatment options and enhancing clinical care.

MCC encountered significant delays in clinical trial activation timelines caused by a combination of inefficiencies within internal processes and complex interactions with multiple external parties. Moreover, although NCI recommends 90-day clinical trial activation timelines for NCI-Designated Cancer Centers, the average among 61 US cancer centers in 2018 was 167 days.^1,2 In comparison, Moores Cancer Center’s average time to activate a clinical trial in 2023 was well over this standard.

Clinical trial activation processes require extensive, cross-functional collaboration between administrative, clinical and regulatory personnel within a central clinical research office. In turn, the clinical research office works with site-based legal, financial, operational, ancillary and technology teams, as well as the local Institutional Review Board (IRB). Clinical trial activation also requires coordination with external parties, including commercial sponsors, government funding agencies and regulatory bodies, contract research organizations (CROs), central IRBs and third-party vendors (e.g., central laboratories, software vendors). Trial sites experience delays in activation due to an inevitable combination of competing priorities across multiple stakeholders combined with regulatory challenges associated with increasingly complex clinical trials.

MCC sought help from Ernst & Young LLP (EY US) to accelerate activation of high-priority clinical trials through implementation of the EY Clinical Trial Fast Lane solution. The initiative had three major objectives:

1. Differentiate MCC based on its time to activation, particularly for high priority “Fast Lane” trials.
2. Leverage EY Clinical Trial Fast Lane solution to implement process improvements in real-time, reducing overall activation timelines for all clinical trials across MCC.
3. Strengthen MCC’s strategic partnerships and key sponsor relationships through demonstrated success in accelerating the activation of high-priority clinical trials.

Moores Cancer Center (MCC) engaged EY US to accelerate clinical trial activation leveraging the EY Clinical Trial Fast Lane solution. MCC and EY US jointly launched the “MCC Fast Lane” initiative for high-priority clinical trials – 20% to 25% of MCC’s total clinical trial activation portfolio.

The EY Clinical Trial Fast Lane solution is designed to activate clinical trials in 45 to 60 working days through rapid performance of functional services, process excellence, deep understanding of clinical trial operations, real-time transparency across all involved stakeholders and prompt risk mitigation. The EY Clinical Trial Fast Lane solution supports clinical trial sites across all major clinical trial activation milestones, including:

• Regulatory submissions, including Disease Working Groups (DWG), Scientific Review Committees (SRC), Protocol Review and Monitoring Committee (PRMC), IRB and other boards as applicable to each trial (e.g., biosafety, radiation safety)
• Medicare Coverage Analyses (MCA)
• Budget and contract development and negotiation
• System set-up, including development of the study billing calendar and set-up in the site’s Clinical Trial Management System (CTMS), Electronic Health Record (EHR) and other financial systems
• Approvals, system set-up and trainings with applicable ancillary teams, such as pharmacy, laboratory, pathology, imaging, infusion, cell processing, etc.
• Principal Investigator and study team forms, disclosures and trainings, including the Site Initiation Visit with the study sponsor

Initially, MCC Fast Lane was applied to “backlog clinical trials” – trials that were pending activation for an average of ~300 days. After initial successes, additional “net-new clinical trials” were identified for MCC Fast Lane jointly by MCC and EY US based on agreed eligibility criteria.

Three key success factors underpinned the successful implementation of the EY Clinical Trial Fast Lane solution and realization of accelerated activation timelines at Moores Cancer Center:

The EY Clinical Trial Fast Lane solution enabled Moores Cancer Center to accelerate activation of its highest priority clinical trials and implement related process improvements to improve clinical trial activation timelines across all clinical trials. As a result, MCC patients had access to these innovative, investigational treatments and therapies up to 11 times faster than traditional timelines for the institution.

The results highlight the significant impact for the institution’s clinical trial activation processes:

Clinical trial activation timelines are a clear differentiator among cancer centers to become a “site of choice” for trial sponsors. As MCC continues to act on its commitment to activate more clinical trials at a rapid pace, it accelerates patient access to cutting-edge therapies and contributes to the improvement of oncology clinical care for all.