At the 2025 SCOPE Summit Conference, industry leaders gathered to discuss the integration of real-world data (RWD) into clinical trials and practice. The panel, featuring Robert DiCicco from TransCelerate Biopharma, Su Chen from MITRE Corp, Jesper Kjaer from Novo Nordisk, Trevan Locke from Duke University, and Chris Decker from CDISC, explored the complexities and opportunities in leveraging RWD for healthcare advancements.
Key discussions focused on data standardization challenges, the role of artificial intelligence (AI), and the necessity of collaborative efforts among diverse stakeholders. The event highlighted the importance of scalable solutions and supportive policies to fully realize the potential of RWD in enhancing clinical trials and improving patient outcomes.
The Complexity of Real-World Data Integration
The panel, led by Robert DiCicco, highlighted the intricate challenges of integrating RWD into clinical trials and practice. The complexity arises from the diverse landscape of data standards and the multitude of electronic health record (EHR) systems globally. DiCicco noted that numerous standard-setting organizations and EHR companies operate with minimal overlap, creating significant hurdles in unifying data integration efforts. Despite these challenges, there is a strong push from government agencies and regulators to leverage RWD for both regulatory and clinical practice purposes. Initiatives like the 21st Century Cures Act and Darwin EU exemplify this growing interest. However, the current approach remains largely bespoke, with each study requiring tailored solutions. The panelists emphasized the need for scalable solutions to streamline the integration process, making it more efficient and effective.
Collaborative Efforts and Technological Advancements
Dr. Su Chen from MITRE provided insights into the progress made through collaborative efforts in standardizing data exchange. She highlighted the work of Codex and HL7 FIHR Accelerator in advancing clinical specialty standards, particularly in cancer genomics. These initiatives have facilitated structured data sharing across 80% of U.S. hospitals, including academic and community sites. This progress has enabled the exchange of cancer and genomics data across life science organizations, labs, and clinics, demonstrating the tangible benefits of standardization. The panelists agreed that multi-stakeholder collaborations are essential in aligning industry drivers and addressing pain points. Organizations like TransCelerate and Vulcan have played a pivotal role in bringing together diverse voices to advance the integration of clinical care and research. These collaborations have led to significant advancements, such as incorporating standardized data exchange in CMS quality care models and public health reporting.
The Role of AI and Digitalization
The integration of AI in clinical research was a focal point of the discussion. Jesper Kjaer from Novo Nordisk shared examples of how AI is used to streamline processes, such as generating clinical study reports and structuring unstructured EHR data. He noted that AI has the potential to transform data processing and analysis, making it more efficient and accurate. However, the panel cautioned against over-reliance on AI, emphasizing the need for a balanced approach that combines AI with robust data standards. Chris Decker from CDISC highlighted the progress made in digitalizing clinical research processes, such as developing a digital protocol. This initiative aims to reduce errors and inefficiencies by digitizing components of trial design, thereby driving innovation and automation. The panelists agreed that while AI offers significant opportunities, investing in areas where it can drive meaningful insights and efficiencies while ensuring that data standards are in place to facilitate interoperability is essential.
Policy and Regulatory Considerations
Trevan Locke from the Duke Margolis Institute for Health Policy addressed the policy landscape, noting the progress of regulatory bodies like the FDA in guiding AI and RWD. He mentioned that the FDA has put out several guidance documents on AI in drug development, outlining a risk-based framework for its use. These efforts are part of a broader initiative to create a supportive regulatory environment for the integration of RWD. However, Locke emphasized that healthcare organizations must be included in these discussions to ensure that new technologies and standards are practical and beneficial for clinical settings. He pointed out that healthcare organizations are overburdened and need to see a clear business case for adopting new data standards and technologies. The panelists stressed the need for policies incentivizing healthcare organizations to participate in these efforts, facilitating broader RWD integration.
Overcoming Technological Challenges
The panel also addressed the technological challenges of handling large volumes of RWD. A participant shared their experience with translating RWD into CDISC standards, highlighting the limitations of current data processing tools. The panel acknowledged these challenges and emphasized the need for continued investment in technological infrastructure to support the growing demands of RWD integration. The discussion emphasized the importance of developing scalable solutions to accommodate the vast data generated in clinical research. The panelists agreed that addressing these technological challenges is crucial in realizing the full potential of RWD to enhance clinical trials and improve patient outcomes. They called for ongoing collaboration between industry stakeholders, technology providers, and regulatory bodies to develop innovative solutions to overcome these hurdles.
Conclusion
The panel emphasized the significant strides in integrating real-world data into clinical research and practice, highlighting the remaining challenges. The discussions stressed the importance of collaboration among industry stakeholders, the strategic use of AI, and the need for supportive policy frameworks. As the industry continues to evolve, these elements will be crucial in realizing the full potential of RWD to enhance clinical trials and improve patient outcomes, ultimately advancing the healthcare industry as a whole.
Moe Alsumidaie is Chief Editor of The Clinical Trial Vanguard. Moe holds decades of experience in the clinical trials industry. Moe also serves as Head of Research at CliniBiz and Chief Data Scientist at Annex Clinical Corporation.
