The clinical trials landscape is undergoing a dramatic transformation, driven by artificial intelligence (AI). Shane Senior, Managing Director and Owner of Crosstree Capital Partners, emphasizes the urgency of this shift, stating that companies must “evolve or die.” While decentralized trials haven’t achieved widespread adoption, AI’s potential to revolutionize clinical trials in the next five years is undeniable.
The Rise of Smart Clinical Trials
The initial enthusiasm surrounding decentralized trials following the COVID-19 pandemic hasn’t resulted in the expected disruption. Senior believes the industry is now entering a new era of “smart” clinical trials, powered by data and advanced technologies. He anticipates a seismic shift away from traditional methods and towards AI-driven solutions.
Disruptive Technologies Across the Trial Lifecycle
Senior highlights several companies leveraging AI to reshape various stages of the clinical trial process:
Trial Design and Feasibility
Companies like TriNetX and BEK Health utilize real-world data to optimize trial protocols and identify suitable patient populations within health systems.
Patient Recruitment and Eligibility
Deep6 AI and XCures leverage unstructured data from electronic medical records (EMRs) and other healthcare systems to refine patient recruitment and eligibility criteria. Platforms like OpenClinica and Protocol First enable direct integration of EMR data into electronic data capture (EDC) databases, facilitating the use of objective endpoints.
Digital Biomarkers and Objective Endpoints
Senior predicts a significant shift towards digital biomarkers and objective endpoints. WCG’s voice inflection biomarker for measuring depression and ActiGraph’s wearable devices (following their acquisition of Biofourmis) exemplify this trend. He believes these advancements will enable studies with fewer patients while generating stronger signals.
Data Management and Interoperability
Tools from MaxisIT, Saama, and eClinical Solutions automate data management using AI, enabling truly adaptive trials and risk-based monitoring with greater cost efficiency.
Medical Writing
AI is significantly impacting medical writing. Senior cites a Narrativa pilot where AI-generated submission paperwork surpassed the accuracy of manually prepared documents. He envisions AI assisting clinicians and biostatisticians, potentially allowing the medical writing process to begin before a trial concludes.
Pharmacovigilance and Drug Safety
Vitrana’s work in pharmacovigilance highlights the potential for AI to automate and significantly reduce the cost of adverse event monitoring. Senior predicts a substantial drop in per-record processing costs, from $50 to potentially $20, through automation.
Challenges and Opportunities in AI Adoption
Despite the benefits of AI, transitioning to a technology-centric approach presents challenges. CROs and pharmaceutical companies often hesitate to adopt new technologies due to regulatory concerns and potential disruptions. However, Senior believes early adopters will gain a significant competitive advantage.
He cites a case where an AI-enabled CRO secured a $150 million global pharmacovigilance program, outcompeting rivals relying on traditional methods. Senior asserts that AI adoption is not a future trend but a current reality, and those who embrace it will “eat this market alive.” He emphasizes the rapid pace of technological development, suggesting that successful companies will leverage existing technologies and focus on integrating them with services and application-managed services.
Conclusion
Crosstree Capital Partners recognizes the transformative power of AI in clinical trials. The industry is on the cusp of a revolution, and companies that fail to adapt risk being left behind. The future of clinical trials belongs to those who embrace AI-driven solutions and capitalize on the opportunities they present.
