Summit for Clinical Operations Executives (SCOPE) 2023 – Orlando, Florida

CHI’s 14th annual SCOPE summit left many attendees with renewed-energy and excitement around the important work the broader clinical research community is doing and the positive impact it has for patients.

This year, the conference welcomed 3300 leaders in clinical operations and research from large, medium, and small biopharma, med device companies, global contract research organizations (CROs), clinical trial tech vendors, sites, academia and patient advocacy organizations. The exhibit hall featured 205 booths showcasing their capabilities and technologies. Thirty-five companies who were exhibiting at the SCOPE entered 40 new products that had been launched since February 2022, in the Best in Show Awards.

The energy was palpable as people reconnected, learnt and shared. There was a constant buzz around the conference centre, booths, interactive breakout and panel discussions. These were my takeaways from SCOPE 2023.

Key Trends Shared at SCOPE

Out of necessity, the pandemic provided a springboard for innovation and an opportunity to challenge the status quo and many great lessons were shared. But there was also a pause for thought and reflection about what will really make a meaningful difference to accelerating clinical trials and making them more accessible for trial participants. Here are some of the themes:

Patient Recruitment: The opportunity for leveraging technology and AI is clear BUT humanizing engagement is still important as it requires a personalised and tailored patient focused approach.

• Convenience: Providing greater optionality for patients via hybrid trials is important as we must respect the precious time given by participants. However, protocol designs still need to be more patient centric.
• Process harmonization and streamlining: The industry must do better as it’s confusing for both sites and patients. Pan pharma consortia like TransCelerate MCTC, CTTI, DTRA. will continue to play a key role in modernising trial conduct as well as technology providers.
• Trust: Takes years to build and minutes to break. We need to address concerns around mistrust in global healthcare systems and the use of personal data.

Diversity, Equity & Inclusion for All: The challenge for our industry is to go beyond intent and get real about how we can make a meaningful difference to ensure our clinical trials better reflect the populations most likely to use new treatments and biologics if approved.

• The Journey: Over recent years our industry has made some Diversity, Equity & Inclusion progress e.g. more focussed entry criteria and study designs
• Regulators: Robust diversity plans are required for new trial proposals and regulators encourage open dialogue with sponsors.
• Technology and Appropriate Oversight: Will play an important role in ensuring the delivery of diversity plan intent. Sponsors and CROs need to to proactively manage recruitment.
• Patient Engagement, Partnership and Education: Embrace new outreach opportunities and listen deeply.

Analytics & Interoperability

Data velocity, volume, value, variety and veracity: There is an increased need and opportunity for automation, analytics and visualizations. Creating near real-time actionable insights is key to ensuring senior executives, study leaders and functional lines are aware of progress against plan during study start-up, recruitment, execution, close out and reporting. They need to react to emerging trends to implement risk mitigation strategies.

• Quality: This is more important than ever, whether it be quality by design, Risk-based Quality Management (RBQM), operational insights or oversight.
• AI/ML Innovation: This isn’t just a buzz word or future aspiration. Auto-mapping is proving hugely beneficial, ML-driven query review is here and there are broader approaches to data classification.

The Power of Co-creation and Collaboration

The future of clinical research requires greater agility, interoperability, and collaboration. We need to be bold and courageous, but always place the patient at the heart of everything we do. New solutions, the harmonizing of data, an openness to change and trusted partnerships are key ingredients.

As digital technologies evolve and health data becomes more readily available, the expectations of the patients we serve will evolve. We must embrace this challenge, listen deeply to their needs, and learn from each other.

Whether exploring novel methods for recruiting and engaging patients, increasing Diversity & Inclusion (DE & I), integrating multiple data systems and technologies or optimising outsourcing strategies, much more can be achieved through collaboration and partnerships. Gone are the days of working in corporate silos. The competitive advantage now lies with those who are willing to collaborate.

As Aristotle wrote “The whole is greater than the sum of its parts”. The key is to keep collaborating, sharing and learning.

SCOPE summit attendees broke a Guinness World Record for wearing aviator glasses (That’s me on the right!)

Author

Jason Gubb

Clinical Operations Consultant and Co-Founder, ClinOpsClarity

Jason Gubb has more than 25 years of experience in global clinical operations strategy and leadership. He has an applied knowledge of leveraging internal and external data, analytics, digital technology and collaborative partnerships to create actionable insights for study teams. Mr. Gubb works with startups, pharma, vendors and contract research organizations (CROs) to develop innovative approaches to optimize protocol designs, modernize clinical trial conduct and accelerate trial delivery.