The Vanguard of Decentralized Clinical Trials: Bayer’s OCEANIC Study
The Medidata NEXT conference spotlighted the groundbreaking OCEANIC study by Bayer, a pivotal phase three global trial, and brought innovative strides in decentralized clinical trials (DCT). Speakers Amy Bohn, Director of DCT Operations at Bayer, and Holly Robertson, Head of Advisory Services, Patient Cloud Operations at Medidata, delved deep into the intricacies and advancements of the OCEANIC study.
Emphasizing Patient Centricity in Clinical Trials
The discussion underscored the shifting paradigm towards patient-centric approaches in clinical research. The narrative was personalized through the panelists’ experiences, highlighting the urgent need to simplify patient access to trials and minimize the associated stress. This patient-first approach is not just a concept but a driving force in the OCEANIC study, emphasizing the crucial role of patient insights in achieving more efficient and certain outcomes.
The OCEANIC Study: A Trailblazer in DCT Strategy
Originally conceived as a hybrid trial, the OCEANIC study became a fully remote option. This transition was driven by the study’s streamlined protocol and the nature of its compounds, ideally suited for direct patient interaction. This innovative shift aimed to enroll 18,000 patients globally, marking a significant milestone in the scale and execution of decentralized clinical trials.
Navigating Challenges: The Road to a Fully Remote Trial
The transformation of Bayer’s OCEANIC study into a fully remote trial encapsulated intricate challenges, from establishing a robust digital infrastructure to guaranteeing seamless patient and site operations. Ensuring technical and operational feasibility involved integrating various technological platforms to manage aspects such as informed consent and data collection while maintaining security and accessibility for patients with diverse technological skills. Implementing a pre-study database was crucial in gauging patient interest, revealing that 50% of participants were inclined toward remote participation, indicating a significant shift in patient engagement preferences. This approach catered to patient convenience and expanded inclusivity by engaging a wider demographic.
Operational challenges were addressed by developing new processes for remote patient engagement and data integrity, necessitating continuous adaptation and real-time feedback mechanisms to promptly identify and resolve emerging issues. The OCEANIC study’s venture into a fully remote trial illustrated Bayer’s innovative response to patient needs and the dynamic potential of technology in clinical research.
Striving for Patient Engagement and Inclusivity
A critical component of the OCEANIC study, as highlighted by Medidata’s Holly Robertson, was to enhance patient engagement and inclusivity. Medidata’s strategies focused on early patient engagement, diversity in recruitment, and a comprehensive patient journey. The partnership with Circuit Clinical was particularly notable for bridging patient self-identification with clinical interaction, ensuring a personalized and inclusive approach.
Technological Synergy and Multi-Stakeholder Collaboration
The OCEANIC study’s success hinged on the seamless integration of diverse technologies and stakeholder collaboration. Key technological solutions included electronic consent, telehealth, ePRO, and digital biomarkers like AliveCor. This integration facilitated a smooth and comprehensive patient journey. The role of home health nurses and central sites further underscored the importance of a supportive and adaptable trial infrastructure.
Learnings and Future Perspectives
The journey of the OCEANIC study provided valuable insights into the execution of DCTs. The key lessons highlighted the need for commitment, agility, and continuous innovation. Each trial’s unique challenges emphasize the importance of adapting to changing guidelines and environments. The study’s evolution during the global pandemic added another layer of complexity and learning.
A Bold Call to Action: Embracing Change in Clinical Trials
The Medidata Next conference culminated with a strong message for industry professionals: be bold and embrace change. Bayer’s OCEANIC study is more than just a trial; it’s a blueprint for the future of patient-centric, decentralized clinical trials. The detailed insights Amy Bohn and Holly Robertson provided highlight the critical importance of patient engagement, technological integration, and adaptive strategies in clinical research. This study caters to the immediate needs of patients and paves the way for more inclusive, efficient, and patient-friendly clinical trials globally. As the industry continues to navigate the complexities of clinical research, the lessons and strategies from the OCEANIC study is another example influencing future trial designs and implementations, marking a new era in decentralized clinical trials where patient needs and technological advancements go hand in hand.