The clinical trial industry is actively working to address key operational challenges, with patient retention and manufacturing partnerships emerging as critical focus areas, according to experts at the 12th Annual Outsourcing in Clinical Trials (OCT) & Clinical Trial Supply (CTS) Nordics meeting in Copenhagen.
Patient dropout rates reaching 30% continue to plague clinical trials, resulting in higher costs, compromised statistical validity, and delayed market entry. Replior CEO Christer Nilsson emphasized these challenges during a session focused on innovative retention strategies.
Digital Solutions and Patient Engagement
Joachim Lovin, decentralized clinical trial (DCT) specialist at Novo Nordisk, highlighted the complexity of the trial information landscape and its impact on participant engagement. "Trial participants often lack valuable education and easy-to-understand information about their participation in a clinical trial," Lovin noted.
Experts proposed gamification as a promising solution to enhance patient adherence and engagement. These strategies include implementing trial journey maps, progress bars, and compliance ratings, combined with disease information delivery and targeted notifications. The approach aims to create a more interactive and motivating experience for trial participants.
John Zibert, CMO of Coegin Pharma, presented compelling data showing that nearly 49% of participants in traditional studies drop out due to transportation and daily life challenges. He advocated for DCTs with remote monitoring capabilities as a solution to reduce patient turnover while enabling real-time data collection.
Manufacturing Partnerships and Innovation
The landscape for clinical trial material manufacturing is undergoing significant changes, particularly in the AAV vector space. Sebastian Bauer, CMC director of CombiGene, characterized 2024 as a "buyer's market" for clinical trial material manufacturing, with increasing competition among providers.
Bauer outlined key considerations for successful CDMO partnerships, particularly for small biotech companies. He recommended a three-stage approach to the request for proposal (RfP) process:
- Initial feasibility study
- Clinical trial material manufacturing
- Commercial production planning
Innovation in manufacturing processes remains gradual due to cost constraints, though promising developments are emerging. The potential shift from plasmid DNA to synthetic DNA in AAV manufacturing could offer significant cost savings and sustainability benefits.
Future Outlook and Recommendations
Industry experts emphasize the importance of adopting fit-for-purpose DCT elements tailored to specific trial needs. The integration of digital tools, while presenting some challenges, often provides benefits that outweigh the disadvantages, particularly in terms of patient retention and data quality.
For manufacturing partnerships, companies are advised to carefully evaluate CDMO experience with specific AAV serotypes and platform suitability. Early planning for production volume becomes crucial when developing therapies intended for large-scale commercial deployment, particularly for chronic conditions affecting millions of patients.
