Season 2 Episode 5: SPECIAL EPISODE The State of Clinical Trials in the U.K. and Europe

This video provides an in-depth exploration of the state of clinical trials in the UK and Europe, featuring Nicole Raleigh of Pharmaphorum interviewing Chris Moore, President of Europe at Veeva. The discussion begins by establishing the global landscape of clinical trials, highlighting key trends such as a growing focus on specialty diseases, the critical need for efficient patient identification and diversity, and the industry's demand for predictability in regulatory conditions. Moore emphasizes that these macro factors significantly influence geographical decisions for trial execution.

The conversation then tunnels into the specifics of UK clinical trials, addressing a concerning 41% decline in new trial initiations between 2017 and 2021. Moore attributes this decline to the uncertainty caused by Brexit, the overstretched NHS, and a lack of supporting capabilities like scanning infrastructure. He notes that while COVID-19 initially impacted trials globally, it also showcased the UK's strength in executing large-scale studies when its structural benefits, such as a unified healthcare system, were leveraged effectively. The discussion transitions to recent positive developments, including the UK government's £650 million investment in life sciences research and the Lord O’Shaughnessy report, which advocates for regulatory reform, speedier study setup, and improved data access. Moore views these as positive first steps, signaling a renewed political consensus on the importance of the life sciences sector.

Shifting focus to Europe, the interview examines the European Commission's proposal for a single market for medicines and the impact of the European Clinical Trials Regulation (EU CTR). Moore acknowledges the positive intent behind harmonizing clinical studies across the EU to rival North America's population access. However, he points out "teething problems," such as discrepancies in national interpretations of rules (e.g., Germany's privacy laws) and the largely manual upload process for approvals. These issues undermine predictability and efficiency, particularly for rare disease treatments and cell and gene therapies, where accessing small, dispersed patient populations is crucial.

Finally, the conversation delves into the pervasive topic of Artificial Intelligence (AI). Moore, drawing on his past experience with IBM Watson, expresses confidence in AI's coming of age. He outlines Veeva's role in providing better data to feed AI and highlights tangible applications within life sciences, such as automated document categorization, CRM chatbots for sales reps, and enhanced safety signal detection. Crucially, Moore stresses the unique challenge in a regulated industry: the imperative for confidence in AI-generated data and answers, distinguishing it from general AI applications where "convincing but wrong" is unacceptable. He suggests a future where AI operates on both a mass data corpus and "within the firewall" data, where quality and harmonization are paramount for reliable decision-making.

Key Takeaways:

• Global Clinical Trial Trends: The industry is increasingly focused on specialty diseases, necessitating efficient and diverse patient recruitment, predictability in regulatory environments, and high-quality data.
• UK Clinical Trial Decline & Recovery: The UK experienced a 41% decline in new trial initiations (2017-2021) due to Brexit uncertainty, NHS strain, and infrastructure deficits. However, recent government investment (£650M) and policy shifts (Lord O’Shaughnessy report) indicate a positive reversal, with a renewed focus on valuing the life sciences industry.
• Impact of Policy Reform: The UK's new national approach to costing and contracting for commercial research has already reduced study setup times by 45% (from 213 to 118 days), demonstrating the immediate positive impact of streamlined processes.
• UK's Structural Advantages: The UK possesses a unified healthcare system and a traditionally positive attitude towards digital solutions, which, if leveraged, could restore its leadership position in digital access, approvals, and overall speed of trial delivery.
• European Harmonization Challenges: While the EU CTR and the push for a single market for medicines are positive steps towards harmonizing clinical trials, national discrepancies in rule interpretation and manual approval processes hinder predictability and efficiency, especially for rare disease treatments.
• Veeva's Role in Friction Reduction: Veeva aims to reduce friction in clinical trials by providing a unified platform connecting pharmaceutical companies, CROs, sites, and patients. They offer free life sciences quality systems to sites and patient-facing tools to reduce site visits and ensure consistent data flow.
• Efficiency and Speed Goals: Through these integrated solutions, Veeva projects a potential for 25% cheaper and 25% faster clinical studies across the industry, alongside improved patient enrollment and engagement.
• AI's Emergence in Life Sciences: AI is "coming of age" with significant potential for applications like automated document categorization, intelligent CRM chatbots for healthcare professionals, and enhanced safety signal detection.
• Data Confidence is Paramount for Regulated AI: Unlike general AI, life sciences cannot tolerate "convincing but wrong" answers. There is a critical need for high confidence in the data feeding AI and the outputs it generates, necessitating robust data quality and governance.
• "Within the Firewall" AI: A distinction is made between AI applied to general public information and AI operating "within the firewall" of a company, where data quality is assured, enabling more reliable decision-making for specific business processes.
• Importance of Data Harmonization for AI: To fully leverage AI, data must be in a harmonized form, accounting for subtleties and context (e.g., conditions under which medical measurements are taken) to ensure accurate and actionable insights.

Tools/Resources Mentioned:

• Veeva platform
• ChatGPT
• IBM Watson

Key Concepts:

• EU CTR (European Clinical Trials Regulation): A regulation aimed at harmonizing the assessment and supervision processes for clinical trials throughout the European Union.
• Lord O’Shaughnessy Report: An independent review advising on making the UK an attractive destination for industry clinical trials, recommending regulatory reform, speedier study setup, and improved data access.
• Clinical Trial Acceleration Networks (CTAENs): Proposed networks to be funded and equipped to deliver "best in world" clinical trial services in the UK.
• Single Contracting: A streamlined approach to contracting for clinical studies, replacing the fragmented system where each care commissioning group required its own contracts.
• Within-the-firewall AI: AI applications that operate on a company's internal, curated, and high-quality data, distinct from AI trained on a general corpus of information, to ensure greater confidence and reliability in regulated environments.