COVER STORY
Harnessing Digital Technology for Future Clinical Trials
By: Vera Kovacevic, PhD
Interviewee: Lindsay Kehoe, Senior Project Manager, Clinical Trials Transformation Initiative (CTTI)
The Clinical Trials Transformation Initiative (CTTI) has been ambitiously working towards its Transforming Trials 2030 Vision, a progressive guidepost for how clinical trials should be conducted in the future.
At the helm of this initiative is Lindsay Kehoe, Senior Project Manager at CTTI, who oversees the development and implementation of some of its various projects.
In this deep-dive interview, Kehoe discusses CTTI's ongoing initiatives and future directions, particularly around the use of digital health technologies (DHTs) to advance novel endpoint acceptance as well as the initiative to embed trials into healthcare settings.
Transforming Trials 2030: Incorporating Digital Approaches
CTTI has recently made significant strides toward its Transforming Trials 2030 goal, specifically in the realm of digital health trials.
"We convened two multi-stakeholder project teams to update two sets of existing recommendations: our decentralized clinical trial (DCT) recommendations and our novel endpoint recommendations," Kehoe explains. She stresses that these teams reviewed past challenges, best practices and lessons learned, to then update the recommendations accordingly.
CTTI’s internal effort to improve user experience led to the restructuring of CTTI's digital health trial resources into the Digital Health Trial Hub. This user-friendly hub offers information on six key areas of digital health trials: planning a DCT, selecting and testing DHTs, managing data, supporting sites, interacting with regulators and developing novel endpoints.
By keeping their recommendations updated and easy to access, CTTI hopes to foster more patient-centered and easily accessible trials.
Overcoming Challenges in Digital Health Trials
The use of DHTs in clinical trials is not without its challenges. Kehoe pointed out a lack of harmonization of laws and regulations for digital approaches as one of the major obstacles. And that cuts across things like telemedicine, data sharing and privacy. Other difficulties include ensuring proper remote monitoring and safety oversight and concerns about the acceptability of DHT-derived endpoints by regulators.
To overcome these challenges, CTTI operates on two levels. First, it serves as a convener of stakeholders to facilitate open dialogue about potential solutions. Second, the initiative transforms these discussions into a set of comprehensive recommendations to provide direction.
Navigating Novel Digital Endpoint Development
The process of novel digital endpoint development also faces significant challenges. These include demonstrating the value of DHT-derived endpoints, limited operational support from technology vendors and concerns about regulator acceptance.
"One noted challenge from sponsors is the difficulty of demonstrating that the use of a DHT-derived endpoint adds value or is better than an existing endpoint," Kehoe points out. “This is then compounded by concerns that operational support from technology vendors is limited because few DHT vendors have clinical trial experience.”
To help mitigate this, Kehoe says CTTI encourages several things in their revised novel endpoint recommendations. For instance, CTTI has reinforced the importance of early and regular engagement with regulators and their project team developed a resource for regulatory engagement that clarifies how and when to engage with the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) when developing digitally derived endpoints. CTTI’s recommendations also stress that the outcome should be identified first and then a suitable DHT should be selected for data capture.
In addition, CTTI developed a process map on how to prepare a DHT-derived endpoint for use in clinical trials. Another valuable resource is CTTI’s question bank for identifying meaningful outcome measures that trial sponsors can use while interacting with stakeholders (particularly patients and caregivers, medical practitioners and insurers).
Kehoe also emphasizes the need to validate the measurement and technology in parallel, yet separate processes, which is laid out in a flow chart of steps for novel endpoint development to clarify the process.
CTTI published these challenges and solutions regarding DHT-derived endpoint acceptance in the journal Digital Biomarkers.
Avoiding Multiple Measurement Solutions
In terms of developing novel digital endpoints using DHTs, Kehoe emphasized the need for coordination to avoid multiple measurement solutions for similar concepts of interest. An example given by Kehoe is that if sleep or improving sleep is a concept of interest, there could be many ways to measure sleep, such as by duration, awakenings or by measuring REM sleep.
Kehoe suggested that patient and caregiver input, along with the right measure for the right context, can help streamline the endpoint development process. She added that sharing knowledge and lessons learned can also help lessen duplicative activities and improve the quality of measures used across different diseases or contexts.
Embedding Clinical Trials into Clinical Practice
The embedding of clinical trials into clinical practice is another area of focus for CTTI. Kehoe shared that CTTI is currently focusing on disseminating its recently released set of recommendations that addressed the design and operational approaches for integrating clinical trials into care delivery.
They're also developing a considerations tool to aid the implementation of these recommendations.
"The tool is for protocol designers, often sponsors and health systems involved in early planning of a clinical trial to consider which trial elements are feasible to embed into clinical practice," says Kehoe. This tool is expected to be available in 2023.
CTTI is also focusing on engagement with initiatives and organizations that are embedding trials at the point of care to understand what is needed to build a data and financial infrastructure that could serve both clinical care and clinical research improvement.
Lastly, CTTI is exploring a measurement initiative to identify progress metrics. "We want to identify metrics that will allow us to appreciate the trials that are indeed becoming more integrated into health processes," Kehoe shares.
Future Aspirations of CTTI’s Digital Health Technologies Team
Finally, when asked about the goals of CTTI’s digital health technologies team, Kehoe explained that the short-term focus is on disseminating the digital health trial work through presentations, workshops and case studies.
"In the long term, CTTI is thinking about our digital body of work more broadly and how it relates to our whole portfolio of clinical trial resources more broadly," adds Kehoe. The goal is to ensure that the digital aspect is integral to their overall vision of transforming clinical trials.
In this era of rapid technological advancements, organizations like CTTI are paving the way for a future where DHTs play a crucial role in making clinical trials more efficient, accessible and patient-centric. Through thoughtful collaboration, continuous improvement and unwavering dedication, they are actively shaping the future of clinical research.
ABOUT Lindsay Kehoe
Lindsay Kehoe oversees the development and implementation of projects at CTTI. She has convened teams around the following initiatives: Embedding Trials into Health Care Settings, Disease Progression Modeling and the use of DHTs to advance Novel Endpoint Acceptance.
With over a decade of clinical research experience, Kehoe brings a rich tapestry of insights to her role. Prior to her time at CTTI, she worked as a rare disease specialist in collaboration with the National Institutes of Health (NIH) and led clinical trials at the Children's National Medical Center in Washington, D.C. She holds a bachelor's degree from the University of Virginia and a master's degree in genetic counseling from Boston University School of Medicine.