How AstraZeneca and Mass General Brigham are Enhancing Clinical Trial Protocol Design

The SCOPE 2025 Summit showcased a groundbreaking partnership between Mass General Brigham (MGB), AstraZeneca, and Evinova, highlighting how these organizations are revolutionizing clinical research through collaboration and technology. Key discussions focused on enhancing communication, utilizing data effectively, and adopting patient-centric approaches to improve trial efficiency and outcomes. This partnership exemplifies the industry’s shift towards integrated research processes, setting a new standard for clinical trials.

The Power of Collaboration

The collaboration between MGB, AstraZeneca, and Evinova represents a pioneering approach in clinical trials, where diverse expertise and resources drive significant advancements. Chris Herrick from MGB emphasized the transformative impact of this partnership, which has fundamentally altered their approach to clinical research. By combining MGB’s extensive healthcare network, AstraZeneca’s pharmaceutical innovation, and Evinova’s digital health solutions, the partnership is setting a new benchmark for clinical trials. This alliance leverages each organization’s strengths, creating a comprehensive framework that enhances trial efficiency and effectiveness. MGB’s 200-year legacy as a premier academic medical center provides a robust infrastructure and a wealth of real-world data. AstraZeneca contributes its vast experience in drug development and patient-centered science, while Evinova brings innovative digital recruitment strategies. Together, they are creating a comprehensive framework that enhances the efficiency and effectiveness of clinical trials.

Enhancing Communication and Data Utilization

A central theme of the conference was the critical role of communication and data utilization in optimizing clinical trials. MGB’s HERO initiative addressed the communication gap between research sites and sponsors. By establishing a holistic communication strategy, HERO ensures that all stakeholders are informed and aligned throughout the research process. This proactive approach includes regular meetings with sponsors to discuss pipeline developments and potential collaborations, facilitating smoother interactions and more effective study planning. In addition to improving communication, MGB has made significant strides in data utilization. The organization has developed a sophisticated system for structuring and standardizing real-world data, which includes genomics, imaging, clinical notes, and patient-reported outcomes. This comprehensive data infrastructure allows MGB to quickly assess study feasibility and identify eligible patients, thereby streamlining the recruitment process. Integrating diverse data types into research protocols is particularly valuable as the industry moves towards precision medicine, enabling more targeted and effective treatments.

AstraZeneca’s Patient-Centric Approach

AstraZeneca’s commitment to patient-centricity was a focal point of the discussion, with Michele Teufel highlighting the company’s efforts to incorporate patient feedback into study design. Using MGB’s extensive database during the protocol development stage, AstraZeneca can make informed adjustments that enhance study feasibility and patient engagement. This approach improves recruitment outcomes and ensures that studies are designed with the patient’s best interests. The company’s Patient Insight team is crucial in this process, providing valuable input on protocol design and patient engagement strategies. AstraZeneca’s patient partnership program allows patients to interact directly with protocol designers, offering insights on inclusion criteria, study procedures, and technology use. This direct feedback loop ensures that studies are tailored to meet patient needs, ultimately leading to more successful recruitment and retention.

Digital Innovation in Patient Recruitment

Kelly McKee of Evinova addressed the persistent challenge of patient recruitment in large hospital systems and the innovative solutions implemented to overcome these obstacles. Despite MGB’s vast network and patient base, recruitment remains complex. Evinova enhances communication and transparency, leveraging HERO’s resources to identify and engage patients more effectively. One of the key strategies involves utilizing both traditional and digital communication channels to reach patients. While digital tools are essential, McKee noted that sometimes traditional methods, such as direct mail, can be surprisingly effective. This multifaceted approach ensures that communication is tailored to the preferences of different patient populations, thereby improving engagement and recruitment outcomes. Evinova’s collaboration with MGB also involves testing protocols through electronic medical record (EMR) mining, allowing for protocol adjustments before finalization. This proactive approach saves time and resources, reducing site-level frustrations and enhancing overall study efficiency. By focusing on optimizing the experiences of patients, sites, and sponsors, the partnership is setting a new standard for patient recruitment in clinical trials.

Expanding the Model

The potential for expanding this collaborative model to other academic medical centers was a topic of keen interest at the conference. Chris Herrick confirmed that MGB actively engages with other institutions to share best practices and streamline research processes. This expansion could lead to a more unified approach to clinical trials, benefiting sponsors and patients by reducing inefficiencies and improving study outcomes. Other academic medical centers’ interest is driven by the need to optimize research processes in the face of financial pressures and operational challenges. By adopting the HERO model, these institutions can enhance communication, streamline data utilization, and improve patient recruitment. From the sponsor’s perspective, having a single entry point to engage with multiple hospitals and systems simplifies the research process and enhances collaboration.

Overcoming Operational Challenges

Operational challenges, particularly those related to institutional review boards (IRBs) and contracting processes, were also addressed during the conference. MGB has significantly reduced these timelines by fostering strong relationships with IRBs and proactively addressing potential issues. By regularly communicating with IRBs and providing advance notice of upcoming studies, MGB has been able to shorten approval timelines, enhancing study initiation efficiency significantly. This proactive approach also extends to contracting processes, where MGB has implemented standardized templates and protocols to streamline negotiations. By anticipating potential issues and preparing stakeholders in advance, MGB has reduced surprises and improved overall efficiency. These efforts demonstrate the value of collaboration and pre-planning in overcoming operational hurdles, ultimately leading to more successful clinical trials.

Summary

In conclusion, the conference highlighted the transformative potential of collaboration and innovation in clinical trials. By integrating communication, data, and patient-centric approaches, the partnership between MGB, AstraZeneca, and Evinova sets a new standard for the industry, paving the way for more efficient and effective research that ultimately benefits patients worldwide.