In a pivotal webcast hosted by Medable, a panel of distinguished experts, including Pamela Tenaerts (Chief Scientific Officer at Medable), Barbara E. Bierer (Professor of Medicine at Harvard Medical School), and technology virtuosos Jeff Nicol (VP, Global Privacy at Medable), and Carl Franzetti (VP, Technology Operations at Medable), explored the burgeoning realm of DCTs, and strategies on incorporating DCT elements and considerations in clinical trials that would likely yield IRB approval. This engaging discussion traversed the spectrum of ethical considerations, participant engagement, and the transformative role of Principal Investigators (PIs) in the digital evolution of clinical trials, highlighting the profound potential of DCTs to enhance research efficacy and participant inclusivity.

Ethical Considerations During IRB Submissions

The panelists illuminated how DCTs are uniquely positioned to maximize effectiveness and secure IRB approval by proactively addressing key ethical considerations. The focus is on creating pathways for innovation within the ethical framework, ensuring that each study is as effective and participant-centric as possible.

  • Accessibility and Participant Burden: Recognizing the diversity in participants’ access to technology, the experts emphasized the importance of inclusive tech design, acknowledging that while technology may present barriers for some, it offers unparalleled access to trials for many others, especially in diverse communities. Efforts to minimize participant burden are central, ensuring that even those with limited data plans can participate fully, thereby democratizing access to clinical research.
  • Data Security in the Digital Age: Transitioning from paper to digital platforms, the panelists shared innovative strategies to enhance data security, addressing potential risks without deterring participation. Through advanced encryption and secure cloud storage, DCTs can protect participant data more effectively than ever.
  • Advancing Safety with Technology: The use of connected sensors for monitoring participant well-being was discussed not as a challenge but as an opportunity to promptly address clinical and safety issues, showcasing the proactive safeguarding of participant health in DCTs.
  • Balancing Technology and Human Touch: The conversation around technology’s role in DCTs focused on its capacity to both enhance and personalize the trial experience. The panelists shared insights into how thoughtfully integrated technology enriches participant engagement without compromising the human element essential to clinical research. This approach ensures that technology serves as an enabler, facilitating deeper connections and understanding between researchers and participants.

Preserving the Human Touch With Technology: Inclusive Design

Jeff Nicol emphasized the critical role of inclusivity in the design of DCTs, ensuring that technology serves as a bridge, not a barrier, for participants. Jeff Nicol’s insights highlight the diversity of participants’ technological comfort and access, stressing the importance of adaptable design features like adjustable font sizes and straightforward navigation to accommodate various needs. “Who are these folks from an accessibility perspective? Do they need to see a larger font?some people might not know how to do a Bluetooth pairing.” This approach aims to make DCTs accessible to all, recognizing that effective design can significantly enhance participation across diverse communities.

Moreover, the deployment of empathetic support systems, such as responsive help widgets, help desks and patient liaisons, is integral to maintaining the human touch in DCTs. These features ensure personalized support, reflecting an understanding of participants’ unique backgrounds and maintaining the trust, rapport, and cultural sensitivity essential to clinical research. By prioritizing user-friendly interfaces and inclusive communication strategies, DCTs leverage technology to foster community and connectivity, enhancing the participant experience while preserving the essence of human interaction at the heart of clinical trials.

Transforming eConsent – Infusing eConsent With Interactive Educational Elements

Adopting eConsent in decentralized clinical trials significantly advances participant engagement and convenience. However, key considerations were discussed involving regulatory and patient-centric eConsent designs and various ethical and practical elements.

  • Comprehension: Ensuring that participants fully understand what they consent to, which may require the consent language and content to be as clear as possible and, when necessary, supplemented with visual aids or videos – rather than having participants skim over lengthy language, comprehension can be enhanced by adding simple and effective interactive educational methods.
  • Verification of Identity: The process must confirm that the person giving consent is the participant or their legally authorized representative, which is not as straightforward as obtaining consent in person.
  • Platform Security: The security of the electronic platform used for eConsent must protect participants’ personal and health information, especially as it may involve third-party vendors.
  • eSignature Legality: Electronic signatures must comply with local laws and regulations, ensuring they are as legally binding as traditional signatures.

Social Media Recruitment in Decentralized Clinical Trials

The panelists then delved into the increasingly prominent role of social media in recruiting participants for DCTs, representing a paradigm shift in clinical trial enrollment strategies. This approach, thoroughly explored by panelists, provides an innovative avenue for reaching potential participants who might otherwise be unaware of or inaccessible to clinical trials. The key considerations discussed include:

  • Broad Audience Engagement: Social media enables trials to reach a diverse array of potential participants, including underrepresented groups and those in remote locations, expanding beyond traditional clinical settings.
  • Ethical Recruitment Practices: The panelists stressed the need for ethical recruitment on social media. This involves creating unbiased materials, transparently communicating trial details, respecting user privacy, and adhering to platform policies.
  • Remote Processes for Enrollment: A key aspect of DCTs is facilitating initial participant engagement and consent remotely. Social media guides potential participants to online platforms for learning about the trial, providing eConsent, and beginning enrollment, eliminating the need for initial physical visits.
  • Managing Online Participant Interactions: Effective management of social media interactions among participants is vital. This approach helps prevent misinformation, protect participant confidentiality, and uphold the trial’s integrity.

The Changing Role of the PI in DCTs

As the webinar concluded, the evolving responsibilities of PIs in DCTs were thoroughly examined. Reflecting on this shift, Barbara Bierer raised a crucial question that encapsulates the core challenge faced by PIs in DCTs: “how does PI oversight of research personnel, protocol compliance, and participant safety be provided at a distance?” This inquiry emphasizes the transition toward a model where flexibility and technology become pivotal in managing trial operations remotely, aiming to maintain the effectiveness and integrity required for IRB approval.

  • Adapting to Remote Oversight and Management: The discussion highlighted the necessity for PIs to adapt to overseeing trial activities from a distance. The discussion around remote oversight implies a significant reliance on technology to maintain protocol compliance and manage teams effectively. This adaptation showcases the proactive steps PIs can take to ensure trial integrity and participant safety without the benefit of traditional in-person interactions.
  • Maintaining Communication and Compliance: Central to the discussion was the importance of ensuring that all team members, regardless of their location, remain well-informed about their roles, responsibilities, and trial protocols. The shift to DCTs necessitates innovative approaches to communication and delegation, ensuring that despite the physical distance, the collaboration remains strong and the trial’s goals are met with high efficiency.
  • Upholding High Standards Across Decentralized Sites: A vital aspect of the conversation revolved around maintaining regulatory standards and quality assurance in a decentralized trial setting. The emphasis was on the importance of PIs understanding varied regulatory environments and implementing robust mechanisms for quality control, even when direct, on-site supervision is not possible. This part of the discussion reflects the critical role of PIs in navigating the complexities of DCTs to ensure compliance and protect participant welfare.

Conclusion

The insights offered by these experts paint a dynamic and promising future for DCTs. Their discussion highlighted the complexities inherent in integrating technology with clinical research and focused on the potential for DCTs to revolutionize patient involvement and trial management. As we look ahead, these perspectives serve as a roadmap for navigating the evolving landscape of clinical trials, emphasizing the importance of adapting to technological advancements while upholding ethical and participant-centric practices.

This article is sponsored by Medable, Inc.

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Moe Alsumidaie Chief Editor
Moe Alsumidaie is Chief Editor of The Clinical Trial Vanguard. Moe holds decades of experience in the clinical trials industry. Moe also serves as Head of Research at CliniBiz and Chief Data Scientist at Annex Clinical Corporation.