Ensuring consistency and accuracy in data collection through digital health technology (DHT) is paramount in the rapidly evolving landscape of clinical trials. Under CEO John Gannon’s leadership, Blue Spark Technologies, Inc. has made significant strides with its innovative TempTraq device. Angela DeLuca, VP of Oncology & Cell Therapy Clinical Operations at Takeda, and Dr. MaryAnne Rizk, CEO of Rizk Management AI Advisors, are joining the discussion. Together, they explore how TempTraq, a fever monitoring device, revolutionizes patient monitoring in clinical trials, addresses challenges, and sets new standards for global regulatory compliance and operational efficiency.

How does Blue Spark Technologies ensure the consistency and accuracy of TempTraq in large-scale, multi-center clinical trials?

John Gannon: It all starts with the device’s fundamental design. We engineered TempTraq to address the complexities of decentralized clinical trials. Its lightweight, disposable, and wireless features facilitate easy deployment and use across diverse patient populations and locations. These design choices enhance patient comfort and reduce potential data collection variances. Rigorous digital health technology clinical trials at institutions like the Cleveland Clinic and the University of Michigan Medical Center and  FDA clearance have validated TempTraq’s reliability and precision, confirming its ability to detect significant temperature variations early, crucial for managing patient health and improving outcomes.

Dr. MaryAnne Rizk: AI-powered DHT tools provide predictive intelligence, which is an essential site management tool for improving the standard of care for patients.  This DHT example with TempTraq’s early signal detection improves the standard of care by identifying fevers earlier than the current standard of care. This enhances monitoring convenience and optimizes resources at clinical sites by reducing physician burnout, streamlining administration, and enhancing cost-effectiveness. BlueSpark technologies are trusted by 16 of the largest US hospital oncology collaborators adopting TempTraq given the proven remote patient monitoring capabilities signal to detect infections before they happen. From an ROI perspective, this DHT empowers

Dr MaryAnne Rizk CEO of Rizk Management AI Advisors

sponsors to reduce overall costs by reducing outpatient care to remote settings. Collaborations with organizations like CancerX and DiME support global initiatives to improve safety, compliance, and sustainability. As a trusted partner for many pharmaceutical companies, we help them become the sponsor of choice for clinical sites. The initiative and easy user-friendly design ensure patients often don’t realize they’re wearing the device, further improving adherence engagement and the overall quality of the standard of care. By staying responsive to the Dec 2023 FDA Digital Health Technologies for Remote Data Acquisition in Clinical Investigations Guidance document regulations and evolving continuously, we ensure that every patient receives the care and convenience they deserve.

What were the most significant obstacles during the FDA clearance process for TempTraq, and how did overcoming these shape your approach to future product development?

John Gannon: The FDA clearance process for TempTraq presented several significant challenges, particularly concerning the safety and performance standards we needed to meet to ensure broad usability. One of the primary hurdles was adhering to the ASTM 1112 standard, which sets rigorous benchmarks for the accuracy and reliability of medical devices that monitor human temperature. Achieving this standard required extensive testing and refinement of TempTraq to ensure precise and consistent results under various conditions. Additionally, a significant focus was placed on the bio-compatibility of the adhesive used in TempTraq. This device component needed to be safe and non-irritating for all potential users, including vulnerable populations such as children and the elderly. This necessitated a thorough evaluation and testing phase to select an adhesive that met these criteria without compromising the device’s overall functionality.

The insights gained from navigating the FDA’s stringent safety and performance requirements have instilled a heightened commitment to rigorous testing and quality control in our development process. We now prioritize these aspects from the earliest stages of design to ensure that each new product meets regulatory standards and exceeds them, safeguarding user safety and enhancing device efficacy. This experience has also encouraged a proactive stance in regulatory compliance, leading us to engage more deeply with standards bodies and regulatory agencies during the design phase, which helps streamline the approval process and ensures our products can reach the market faster without compromising quality.

John Gannon CEO of Bluespark Technologies

How does Takeda ensure continuous compliance with global regulatory standards when incorporating technologies like TempTraq into clinical trials?

Angela DeLuca: At Takeda, ensuring compliance with global regulatory standards is paramount, particularly when integrating advanced technologies like TempTraq into our clinical trials. The fact that TempTraq is already FDA-cleared significantly streamlines the integration process, as it meets established safety and efficacy benchmarks that regulatory bodies are looking for. This pre-clearance alleviates many potential hurdles related to regulatory compliance, enabling us to focus on applying the technology rather than the validation process. Additionally, the continuous data provided by devices like TempTraq enhances our ability to conduct real-time monitoring and adjustments during trials, which is crucial for meeting the stringent monitoring standards required by global regulatory agencies.

Using devices like TempTraq also aligns with our patient-centric approach by improving the overall trial experience for participants. The device’s non-intrusive and continuous monitoring capabilities ensure high-quality data and improve patient comfort and compliance, which are increasingly important in clinical trial design. This enhancement in patient retention and satisfaction directly contributes to the robustness and reliability of our trial results, making our data more compelling to regulatory authorities.

What operational challenges have you encountered with implementing continuous monitoring of Digital Health Technology in your studies, and how have these impacted timelines, costs, and data quality?

Angela DeLuca: Integrating digital health technologies into our clinical trials has presented various operational challenges, especially in training and adaptation for our internal teams and staff at clinical sites. The learning curve associated with these new technologies can initially slow down processes and require additional resources for effective training and support. However, the extensive prior utilization of TempTraq across multiple institutions has allowed us to refine our training protocols and integration strategies. This prior experience has been instrumental in mitigating potential delays and has facilitated smoother transitions in subsequent trials.

Moreover, adopting digital health technologies has significantly impacted our clinical trial timelines, costs, and data quality. By providing continuous and reliable data, DHTs have enhanced our trial results’ robustness and improved our ability to monitor patient safety in real-time. This has reduced the incidence of adverse events and decreased the need for costly post-trial data corrections and follow-ups. Ultimately, the initial investment in training and technology integration is offset by considerable gains in operational efficiency and data integrity, which are crucial for accelerating the development timelines and reducing the overall costs of clinical trials.

Angela DeLuca VP of Oncology Cell Therapy Clinical Operations at Takeda

How is TempTraq currently used in Takeda’s clinical trials, and how might it be employed in measuring study endpoints in the future?

Angela DeLuca: In our current clinical trials at Takeda, TempTraq is primarily being looked at for safety monitoring. Its advanced capabilities in digital health technology allow for the precise and early detection of fever. This is particularly crucial in therapeutic areas such as oncology, where even slight changes in body temperature can signal important biological reactions to treatments. The data provided by TempTraq is invaluable for ensuring patient safety and making real-time adjustments to trial protocols, thereby enhancing our studies’ overall integrity and responsiveness.

Looking to the future, we see a transformative role for TempTraq in endpoint measurement within clinical trials. The ability of digital health technology like TempTraq to provide continuous, real-time data presents a significant opportunity to move beyond traditional endpoints and to begin incorporating dynamic biomarkers like temperature changes as primary indicators of drug efficacy and patient response. This could revolutionize how outcomes are measured in clinical trials, particularly in areas like oncology, potentially accelerating the development of new therapies and improving patient outcomes through more targeted and timely interventions.

What are your plans for using digital biomarkers like those provided by TempTraq? Will you focus on retrospective data analysis or develop new biomarkers?

Angela DeLuca: At Takeda, we actively explore the potential of digital biomarkers obtained through devices like TempTraq to transform clinical research and patient monitoring. Our current focus is on harnessing real-time data to develop new digital biomarkers to provide more immediate and accurate insights into patient health during trials. We are particularly interested in identifying early indicators of disease progression or treatment response that could significantly improve patient outcomes.

Moreover, we are collaborating with leading technology companies to push the boundaries of what’s possible with digital health technology. These partnerships are crucial as they help us navigate the complex regulatory landscape and set new standards for digital biomarker use in clinical trials. We aim to leverage these advanced technologies for retrospective data analysis and create a robust framework for developing and validating new biomarkers. By staying at the forefront of digital innovation, we aim to ensure that our clinical trials are more adaptable, patient-centered, and precise, leading to faster and more effective patient treatments.

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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.