Themes on the path to revolutionize clinical trials at SCOPE Summit 2024

The SCOPE Summit 2024 recently brought together heads of R&D, industry experts, and innovators around Super Bowl Sunday to explore the evolving landscape of clinical trials. Amidst the discussions on goals and works-in-progress across several key areas, it’s evident that while the vision for transforming clinical trials is ambitious and shared, we’re developing this playbook as we go.

Key themes surfaced at SCOPE 2024, highlighting the most effective strategies stakeholders are deploying to navigate the challenges and seize opportunities within the industry. These include the adoption of innovative technology, the push for personalized and decentralized clinical trials, and the use of data to make it all happen.

The potential of AI and technology in clinical trials

One of the more commonly discussed topics at SCOPE Summit 2024 was the potential of artificial intelligence (AI) to transform the clinical trial landscape. From expediting timelines and reducing costs to driving more personalized and human engagement of study subjects, there’s a clear recognition that AI could revolutionize the way clinical trials are conducted.

However, despite top-down initiatives at many leading life sciences companies, the reality is that there are many challenges with AI, and teams are still at the beginning stages of adopting this technology. Limited access to data, change management, and uncertainty about how to leverage it effectively are significant barriers that need to be addressed.

Despite the potential, AI still seems somewhat distant from broad and routine use. Companies are early in reaping the benefits of its applications, such as using natural language processing (NLP) for clinical trial design or to enable novel study types.

On the other hand, implementing technology to streamline and strengthen study design and operations, such as automated patient identification and screening at study sites, is providing immediate value.

Diversity and inclusion to drive health equity

One area to remain cognizant of while embarking on this transformative technology journey is bias. Current efforts to build analytical platforms and curate data have largely focused on generating intelligence from data in hand and historical benchmarks.

At the same time, expert speakers and panelists across the SCOPE 2024 conference hallway stressed the lack of diversity, inclusivity, and representation for racial/ethnic, LGBTQA+, disabled, and other communities in clinical research to date. Here, the tone was powerfully personal: humans coming together to affirm the importance of representing each future patient in current clinical research.

Panelists at the LGBTQA+ sessions offered seasoned advice on how to make this happen from the ground up:

• Take a step back and assess. It’s grounding.
• Ensure there are allies involved, including executive sponsors and champions to power peer-to-peer conversations.
• Target cross-practice change, and achieve it step by step. Not all protocol updates need to happen at once, and not all studies need to evolve at once. The smallest changes can make a difference, all the way down to an “All are Welcome” sign in the waiting room and use of more inclusive language such as having an investigator ask a patient about their spouse/partner instead of their husband/wife.
• Use data to make change happen. Having data and evidence to support conversations and fuel change management efforts can be the key to effective transformation, including where to focus efforts and investment in the reality of a limited budget.

Convergence and divergence in real-world data

At the heart of these SCOPE Summit 2024 discussions lies the importance of data in driving meaningful change in clinical trials. Real-world data (RWD) plays an increasingly vital role both at the organizational level and the personal level.

Case studies presented at SCOPE 2024 highlighted an increasing use of RWD in everything from investigator and site identification and selection, patient recruitment, study design and execution to the enablement of novel study types and the effective transition from development-stage to post-market evidence.

RWD is also starting to address diversity and inclusion issues by providing evidence to support the inclusion of diverse patient populations in clinical trials. While some teams are becoming more comfortable with using RWD for study design and evidence generation, there’s still a prevalent siloed thinking that hampers progress for traditional clinical development practices.

Thus, there is still work to be done in driving essential education and collaboration to bridge this gap and fully realize the potential of RWD to improve how clinical studies are conducted.

Whether it’s leveraging AI to optimize trial designs, embracing RWD for evidence generation, or ensuring diversity and inclusion through data-driven strategies, the underlying foundation is access to and responsible use of data.

Tokenization, availability, and access to data are key factors that can enable organizations to run studies more effectively and make informed decisions.

The path forward: Big data, personalized trials

As we navigate the evolving landscape of clinical trials, it’s clear that incorporating data-driven approaches is essential to stay ahead of the trend. SCOPE Summit 2024 underscored the transformative potential of data in revolutionizing clinical trials.

From embracing AI and real-world data to fostering diversity and inclusion, data-driven approaches are crucial for driving meaningful change in the industry.

In the same way that patients increasingly seek personalized treatment options based on data-driven insights, harnessing big data and novel technology to offer patient-centric experiences will lead to more effective and inclusive studies.

Unlike the Super Bowl where one team takes home the trophy, our goal at the end of all of this is that every patient wins. By leveraging data, we can not only deliver novel therapies to patients faster to improve health outcomes, but also empower all patients to make informed decisions about their healthcare.

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