In the rapidly evolving landscape of clinical research, Decentralized Clinical Trials (DCTs) are emerging as a transformative approach, redefining how studies are conducted at ONL Therapeutics. As the industry navigates this shift, the concept of “Bring Your Own Device” (BYOD) is gaining traction, offering potential benefits and challenges in equal measure. Ophthalmology, with its unique requirements, stands at the crossroads of this change, exploring the possibilities that Virtual Reality (VR) devices bring to the table. In this interview, we delve deep into the nuances of DCTs, BYOD strategies, and the role of VR in ophthalmology, shedding light on the future trajectory of clinical trials. Join us as we discuss these groundbreaking trends with David Esposito, CEO of ONL Therapeutics.
Moe Alsumidaie: Given your unique position in a smaller biopharmaceutical company and your deep involvement in Decentralized Clinical Trials (DCTs), I’m curious about your viewpoint. What similarities or differences do you observe in the approaches organizations are taking towards DCTs?
David Esposito: Moe, you’ve zeroed in on a crucial aspect of the evolving clinical trial landscape. Our company stands solidly behind efforts to refine the execution of DCTs. The inclination towards telehealth, wearables, and other innovative tools like Virtual Reality (VR) signifies the industry’s forward-thinking. However, in the niche of ophthalmology, our treatments often involve specific eye injections.
These treatments necessitate standardized vision tests, which can be hard to replicate in a decentralized setup. The move towards Bring Your Own Device (BYOD) methodologies in clinical trials, while promising, presents challenges given our specific assessment needs in ophthalmology. Yet, for other medical conditions, wearables that monitor vital metrics are transformative. Emphasis remains on ensuring the reliability and integrity of these measurements. The upside? Such advancements make trial participation significantly less daunting, especially for vulnerable demographics.
Moe Alsumidaie: With the buzz growing around Bring Your Own Device (BYOD) in the context of DCTs, how do you perceive this trend, especially when data standardization and security come into play?
David Esposito: The BYOD paradigm in DCTs offers both promise and challenges. It can significantly elevate the patient experience, especially if they can utilize devices they’re comfortable with. Yet, this comes with the immense responsibility of data security and consistency. The challenge amplifies when we aim to standardize data sourced from diverse devices while meeting rigorous regulatory standards. But my optimism is anchored in technological progress. With the rise of Virtual Reality (VR) and other advanced tools, I believe BYOD will become a cornerstone in DCTs, fostering a patient-centric ethos without compromising on industry standards.
Moe Alsumidaie: If BYOD were to be integrated into your studies, especially in ophthalmology, how do you envision it? Are there specific VR devices or assessments that you find promising?
David Esposito: Within the confines of ophthalmology, Virtual Reality (VR) devices like Oculus are carving a niche. For instance, Oculus is being used experimentally to evaluate pupil function. I can envision gadgets that offer routine intraocular pressure assessments or VR headsets that gauge contrast sensitivity using state-of-the-art software algorithms. While high-resolution imaging techniques may still require specialized setups, there’s potential for routine tests to be conducted remotely using BYOD strategies. Practical vision tests, resonating with those endorsed for treatments like Luxturna, could be mirrored in a VR domain. Such innovations align with practical needs and also echo regulatory perspectives.
Moe Alsumidaie: What challenges do you expect to see globally in implementing DCTs and BYOD?
David Esposito: While much of our conversation is deeply rooted in the U.S. context, takes on a different hue when viewed globally. The challenge of synchronizing cutting-edge technologies across diverse regulatory landscapes and trial centers can’t be understated. While the U.S. presents its set of intricacies, global perspectives introduce added layers of complexity, especially when considering DCTs that span beyond U.S. borders. Data variability, particularly in a global setting for DCTs, is a critical consideration. While some evaluations can be standardized, intricate ones can pose challenges, especially when harmonizing data across diverse BYOD devices and settings. The path forward is about balancing innovation with unwavering data integrity.
Moe Alsumidaie How do the advantages of Decentralized Clinical Trials (DCTs), the Bring Your Own Device (BYOD) approach, and the integration of Virtual Reality (VR) in ophthalmology measure up against the challenges they present in ensuring precision and data consistency?
Embracing Decentralized Clinical Trials (DCTs) in ophthalmology broadens patient reach and enhances convenience. However, the sector’s precision demands raise standardization concerns. The “Bring Your Own Device” (BYOD) approach, while boosting patient comfort, introduces data security and consistency challenges due to varied device usage. Virtual Reality (VR), especially tools like Oculus, holds promise for innovative vision assessments in ophthalmology. Yet, ensuring their accuracy to match traditional standards remains a hurdle. As we navigate this terrain, balancing innovation with precision is crucial.
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.