Shaping the future of clinical trials through strategic foresight.

Abstract

Background/aims: Global megatrends, including population growth, interconnectedness and artificial intelligence, are already shaping the clinical trials industry, and will do so for decades to come. Innovations from technology companies, greater collaboration with patients and caregivers, and increased diversity in clinical trials could transform clinical trials of the future. However, the industry has typically been slow to adopt new technologies, and certain barriers could stifle innovation and allow health inequalities to persist. Our aim was to explore the trends shaping clinical trials and identify initiatives that can be started now to move toward a future where patients are actively involved in clinical trial design and decision-making, and technologies like artificial intelligence are integrated responsibly and ethically into clinical trials.

Methods: We used strategic foresight methodology to explore the trends that will shape the future of clinical trials and how the trajectory of these trends could lead to different future scenarios We then identified initiatives that could help us move toward our desired scenario.

Results: We identified four possible scenarios for the future of clinical trials based on two key trends: data sharing and adaptation of regulatory frameworks. While the future will see collection of large amounts of data from different sources, such as databases and wearable devices, their usefulness could be limited if data remain in silos, limited by strict regulations and a lack of trust in data privacy. Alternatively, data may be integrated more efficiently into clinical trials if regulators adapt proactively to new technologies and patients are empowered to take control over their data, for example. We identified initiatives that can be started now to achieve our vision. Pharmaceutical companies, academic researchers, non-governmental organizations (including patient organizations), regulatory authorities, policymakers, technology companies and innovative service providers must join forces and work on initiatives to integrate technology into trials, enable data sharing, harmonize regulations across regions, co-design trials with patients and caregivers, strengthen decentralized trial capabilities and promote diversity in trials.

Conclusion: Through a collaborative cross-industry effort that prioritizes proactive patient involvement and responsible use of technology, we can shape a clinical trial ecosystem that is inclusive, ethical and ready for the future. We urge all stakeholders to act now on these initiatives to positively influence the future of clinical trials.