SCOPE Summit 2024: Modernizing and Personalizing Clinical Trials  

SCOPE 2024 kicked off with 4,000 attendees traveling to Orlando, Florida, for the much-anticipated event. Common themes shared across all sessions include the importance of collaboration, focusing on patients and their caregivers, and avoiding a “one size fits all” approach to designing clinical trials. Read on for the highlights from TransCelerate’s seven sessions.  

The conference commenced with a keynote panel featuring TransCelerate CEO Janice Chang, our Board of Directors members Uli Broedl (Boehringer Ingelheim) and Christoph Koenen (Bayer), and moderator Katherine Taylor (Merck). 

“The Next Horizon of Clinical Research: A Multi-Stakeholder Panel on Integrating Research into the Care Continuum” had a lively discussion on why it’s critical to start converging clinical research into clinical care. 

Panelists explored the steps and rationale for getting to this future state:  

• “It’s about learning how to manage health instead of just managing diseases.” Janice emphasized how important it is to modernize tomorrow’s clinical trials and to shift the model from recruiting patients to clinical trials to integrating clinical research into an accessible healthcare system’s standard of care and bringing clinical research to them.  
• “The best way to predict the future is to create it.” Uli quoted Abraham Lincoln and painted a picture of how the ecosystem can achieve this future state. He described how space travel was only accessible for astronauts until SpaceX came along and changed how the model operated. He shared how clinical research is on the  precipice of such an opportunity.  
• “Don’t just collect data for the sake of collecting data.” Janice advised attendees on the industry’s obligation to optimize collected data for reuse. Not only does she remind the audience to ensure high-quality data, but she also keeps in mind the quality of innovation. Engage Health Authorities, payers, and other stakeholders to craft a more inclusive and efficient system. 
• “Don’t be afraid to be creative, to borrow and learn from other industries.” Christoph shared that historically, the industry has focused on speed and quality. While that hasn’t changed, we need to redefine quality to be more inclusive of the  industry quality to society and patients, beyond drugs to ways to make and keep them healthy. 

Next, Jean Sposaro (BMS) gave a session on “A Paradigm Shift in Personalizing the Clinical Trial Experience for Patients and their Care Partners.” This session was to encourage the ecosystem to enable the return of individual data to patients. Throughout a person’s life, their healthcare data is collected, and they can access  their electronic health records (EHRs). However, clinical research data is omitted from this picture.  

“Let us create a real partnership with patients,” said Jean. “It’s certainly not one size fits all but moving away from that is what personalized medicine is.” Returning individual participant data is an opportunity to bridge the gap between healthcare and clinical research. It can optimize inclusion, diversity, health equity, and access. Specifically, she advises that sponsors become proactive in this new operational process now, as Health Authorities may decide to require it in the future to meet this need. 

Joachim Lovin (Novartis) spoke on behalf of TransCelerate’s Modernizing Clinical Trials Initiative for a session on “Enabling Greater Flexibility in Conducting Clinical Trials—Lessons Learned.” 

Joachim demonstrated the Operational Complexity Assessment Tool and TransCelerate’s Process Frameworks and guided attendees through considerations when implementing Decentralized Clinical Trial (DCT) elements. Echoing our keynote session, Joachim reminded attendees to keep the patient as the focus and have a plan for data collected during a clinical trial.  

He concluded the session by previewing the TransCelerate member survey results on 50 clinical trials using DCT elements. Full findings will be released in an upcoming journal publication.  

Rob DiCicco (TransCelerate) gave an update on our Digital Data Flow Initiative in his talk “Digitalizing Clinical Protocol Information to Accelerate Clinical Research and Pharma to Healthcare Interoperability.”  

“The last thing you want to do is layer new technology on top of old processes that no longer work for us,” said Rob. “We are just at the beginning of digitized protocols and the operations around them, but the industry is picking up.” He echoed others about thinking proactively to design and implement new technologies and understanding that change curves can take years to become everyday practice and realize full benefits. 

He highlighted the progress organizations like TransCelerate, HL7 Vulcan, ICH M11 CeSHarp, ACRO, EU PEARL, Health Authorities, and CDISC have made to advance data utilization and reuse. 

Our ambition with Digital Data Flow is to move beyond a document-based paradigm for protocol creation, interpretation, and transcription into consuming systems. Instead, we want to help create a digital paradigm for protocol creation, with fully automated data flow and interoperability between systems. 

The next day, Rob joined the panel “Implementation Challenges for Decentralized and Hybrid Trials” alongside Craig Lipset (Clinical Innovation Partners), Gretchen Goller (Seagen), Lindsay Kehoe (Clinical Trials Transformation Initiative), James Bechtel (Society for Clinical Research Sites), and Isaac Rodriguez-Chavez (4Biosolutions Consulting). All panelists stressed that decentralized clinical trials can improve access for patients if it makes sense for each trial. Some key takeaways from the panel: 

• Be clear about the purpose of using Decentralized Clinical Trial (DCT) elements. Is it to improve patient experience, access, site burden, or recruitment? Pick one to guide your application of available recommendations. 
• Simplify clinical trial protocols. 
• Collect and share evidence of successes and failures when implementing DCT elements. 

Our Diversity of Participants in Clinical Trials Initiative lead Sandra Amaro (Pfizer) encouraged sponsors to proactively address the FDA’s upcoming diversity plan requirements in her session “Diversity by Design: Accessing Solutions from the Start.” Addressing the FDA’s recent requests for sponsors to submit diversity plans as part of clinical study design, Sandra advised attendees to create robust diversity plans focusing on enrollment goals. 

She provided an overview of TransCelerate’s “FDA Diversity Plan Early Insights and Considerations” resource and highlighted the four significant lessons learned:  

1. The development of FDA Diversity Plans cannot be treated as a “check-the-box” exercise. 

2. Successful development and implementation of comprehensive Diversity Plans require iterative engagement, alignment, and coordination across functions. 

3. Diversity Plans should be viewed as a dynamic, living document that should be updated and refined throughout the lifecycle of a clinical development program. 

4. The FDA Draft Guidance provides a good foundation for sponsors to evolve more integrated approaches to increasing health equity for patient populations globally. 

Sandra echoed other speaker sessions with the advice that sponsors need help to diversify clinical trials further. “We need partners within communities to improve access,” she said. “Sponsors can make decisions, but we cannot do it alone.” 

For TransCelerate’s final presentation, Joachim presented on behalf of our Patient Experience Initiative in the session “Optimizing Patient Choice, Flexibility, and Outcomes by Personalizing the Clinical Trial Experience.” 

This session introduced the audience to TransCelerate’s Personalized Clinical Trial Framework, designed to help the R&D ecosystem improve patient choice and the streamlined implementation of options into the clinical trial process.  

When asked by an audience member how to overcome the “It’s always been done this way” mindset, Joachim counseled that change managers should be incorporated into the process to address the potential return on investment when integrating new modalities. He also advised that organizations try one or two modalities to ensure success.  

In conclusion, it was an inspiring and informative conference for speakers and attendees alike. Attendees left with awareness of new resources to help them develop and conduct clinical trials, shared experiences, and renewed understanding of the barriers and opportunities facing clinical research.