Digital Health Trials Hub

CTTI Leads Discussion on Digital Health Trials at ETH Digital Biomarkers Summit

CTTI News | November 27, 2024

Topics Included: Data Collecting and Reporting, Innovative Trials, Site Planning

In November 2024, Lindsay Kehoe, senior project manager at CTTI, presented at the Digital Biomarkers Summit held at ETH Zurich. The event gathered experts from academia, healthcare, and industry to discuss the transformative potential of wearable technologies in healthcare. Among the many topics covered, a key focus was the translation of digital innovations, such as wearable devices for sweat and breath, into clinical implementation to revolutionize healthcare. Digital technologies enable real-time, continuous monitoring of patient data, providing researchers and healthcare providers with deeper insights into patient health, improving trial design, and enhancing data accuracy.

In her workshop, Setting Up Digital Health Trials, Kehoe offered actionable insights on designing successful, fit-for-purpose digital health trials. She outlined key benefits, such as improving trial efficiency, fostering patient-centric research, and ensuring more reliable data. Kehoe also addressed common questions and challenges in implementing digital health trials and shared practical solutions for overcoming them. A central theme of her talk was the importance of communication and collaboration, emphasizing that “collaboration is key to bringing cutting-edge innovation into trials, addressing unmet needs, and improving trial efficiency.”

Dr. Jörg Goldhahn, a CTTI member and Professor at ETH Zurich, echoed Kehoe’s point, noting, “New technology offers great potential for novel biomarkers that can be used remotely, closer to ground truth, and on a continuous basis. However, intensive interprofessional collaboration is required to take these technologies from proof-of-concept into clinical use.”

Kehoe also discussed the importance of equipping researchers with the right tools and resources to successfully implement digital health strategies. She introduced essential resources from CTTI’s Digital Health Trials Hub, designed to guide researchers through key aspects of trial design, including selecting measures and appropriate technologies, managing data securely, developing novel endpoints, and collaborating effectively with clinical sites, patients, and regulators for seamless trial execution.

A notable example of how CTTI’s Digital Health Trials Recommendations are being put into practice is at ETH Zurich, where the institution has integrated these recommendations into its Digital Trial Intervention Platform within the Translational Science Advanced Studies program. This platform enhances the flexibility and scalability of clinical research and aims to optimize digital clinical study designs. These initiatives underscore the real-world impact of CTTI’s resources, demonstrating how we can take digital tools from bench to bedside and drive innovation in clinical research.

For those interested in seeing how CTTI’s resources are being applied in other research settings, the Case Study Exchange offers a range of real-world examples, showcasing how different organizations are integrating innovative tools and approaches into clinical trials.

Recent News Feed

Recent Publication Reviews How CTTI’s Digital Health Trial Hub Can Unlock the Potential of Digitalizing Trials

Posted on by Hannah Faulkner

A new CTTI publication, published in Nature Reviews Bioengineering, reviews opportunities for and challenges to using digital health technologies in clinical trials and highlights CTTI’s Digital Health Trials (DHTs) Hub. Digital health technologies have the potential to transform evidence generation in clinical trials, from trial design and participant screening to data capture and analysis. However, digital health technologies introduce new challenges, including concerns around data protection and data quality. The wide variety of available technologies requires that sponsors carefully identify meaningful measures, select and test appropriate technologies for capturing these measures, and train site staff and participants to properly use the selected technologies.

CTTI’s DHT Hub includes tools and recommendations for developing novel endpoints, planning decentralized trials, selecting and testing digital health technologies, managing data, supporting sites, and interacting with regulators. These resources support the effective implementation of DHTs to bring therapies to patients more quickly and efficiently, aligning with CTTI’s Transforming Trials 2030 vision.

Recording Now Available: CTTI Webinar Introducing New Digital Health Trials Hub

Posted on by Hannah Faulkner

A recording of CTTI’s April 6 public webinar introducing the new Digital Health Trials Hub is now available. The one-hour webinar includes presentations from Megan Doyle, Amgen, and Jörg Goldhahn, ETH Zurich; a stakeholder panel featuring Phil Green, CTTI, Elizabeth Kunkoski, FDA, Jeremy Wyatt, ActiGraph, and Reem Yunis, Medable; and a Q&A session moderated by Lindsay Kehoe, CTTI.

CTTI’s Digital Health Trials Hub features new and enhanced resources to help sponsors, investigators, CROs, and technology providers design and run quality, patient-centered clinical trials. The new Hub resources include significantly updated recommendations, revised reference documents, a Question Bank for Identifying Meaningful Outcome Measures, and a Process Map for the development of digitally derived endpoints. These resources are the culmination of CTTI’s 2021 Digital Health Trials work, which highlighted importance of early stakeholder engagement and flexible, tailored approaches to trial design and conduct.

The materials in the new Hub are broken down into six core areas of Digital Health Trial design and conduct:

  • Developing Novel Endpoints
  • Planning Decentralized Trials
  • Selecting & Testing Digital Health Technology
  • Managing Data
  • Interacting with Regulators
  • Supporting Sites

View the slide deck to read more.

 

 

CTTI to Launch New Online Digital Health Trials Hub

Posted on by Hannah Faulkner

CTTI will host a public webinar on Wed., Apr. 6 to introduce a new online Digital Health Trials Hub featuring enhanced recommendations and additional resources. 

“This updated and expanded resource drives CTTI’s bold Transforming Trials 2030 vision by helping sponsors, investigators, CROs and technology providers design and run clinical trials that are patient-centered, easily accessible, and designed with a quality approach,” said CTTI Executive Director Sally Okun. 

The new Hub combines resources that have been restructured from CTTI’s four existing Digital Health Trials projects, completed from 2017 to 2019, along with improvements and new work from two project teams, Decentralized Clinical Trials Updates and Novel Endpoints Acceptance. By creating the Hub, CTTI’s aim is to make the most relevant information more useful and accessible for those in the clinical trials enterprise who are designing and running patient-centered trials. 

Key enhancements and additions made to the Hub include significantly updated recommendations, revised reference documents, and two new resources – the Question Bank for Identifying Meaningful Outcome Measures and a Process Map for use of a digitally-derived endpoint in an individual drug development pathway. These enhancements are the culmination of CTTI’s 2021 Digital Health Trials work that highlighted the importance of early stakeholder engagement, flexibility and tailored approaches to trial design and conduct, and flexible support of sites. 

The free one-hour webinar, which includes presentations from Megan Doyle of Amgen and Jörg Goldhahn of ETH Zurich, will begin at 11:00am EDT and registration is available online on CTTI’s website. 

CTTI Paper Reveals Investigator Perspectives on Advantages and Challenges of Digital Health Trials

Posted on by Hannah Faulkner

Now more than ever, mobile technology is affecting every aspect of our lives, including the way we conduct clinical research. In a new preprint manuscript, CTTI examines the investigator experience in digital health trials.*

In-depth interviews conducted with 12 investigators representing an array of clinical specialties revealed the benefits and challenges of incorporating mobile technology into clinical trials through the use of smartphones, tablets, notebook computers, and wearable devices.

Some common benefits of digital health trials cited by the investigators include:

  • Streamlined study operations and data collection
  • Simplified and continuous study data capture throughout the trial
  • Improved study and data quality and an increase of “real-world” results

The manuscript also details specific challenges investigators faced when using digital health technologies in trials. These include an increase in the amount of time needed by investigators and study personnel to review data and maintain the technology, additional training, technology adoption barriers for participants and staff, and uncertainty with data validity. These potential obstacles must be proactively addressed in order to harness the full benefits of digital health trials.

Learn more about CTTI’s Digital Health Trials work.

*CTTI’s Digital Health Trials work was previously called “Mobile Clinical Trials”.

CTTI Article Sheds Light on Participants’ Views of Mobile Clinical Trials

Posted on by Lorri Bingham

While adoption of mobile technologies presents many opportunities to enhance the quality and efficiency of clinical research, questions remain on patients’ preferences surrounding the use of mobile technologies in clinical trials. To help trial sponsors and others maximize the potential offered by mobile technologies, CTTI surveyed a group of potential research participants and recently published findings from the survey in Contemporary Clinical Trials Communications.

The survey results, which include responses from 193 individuals ages 23 to 83, shed light on the respondents’ perceptions of and willingness to participate in mobile clinical trials. In the survey, participants were presented with two similar hypothetical clinical trial scenarios: 1) relying on participants’ use of wearable and other mobile technologies outside of the clinic setting to collect study endpoints, and 2) relying on traditional in-clinic follow-up appointments with study staff to collect study endpoints. About 81 percent of respondents said they were willing to participate in the hypothetical mobile clinical trial, while only about 51 percent were willing to participate in the similar traditional clinical trial.

If given the option of participating in either scenario, the majority of respondents (76 percent) said they would prefer to participate in a mobile trial over a traditional one, citing greater convenience, fewer in-person visits, and perceived greater data collection accuracy offered by the mobile technology. Respondents were willing to use a variety of technologies―including mobile apps, wearable devices, and ingestible sensors―provided they were comfortable, convenient, and easy to use.

The survey also collected data about the aspects of mobile clinical trials that cause participants concern. Those who are less familiar with technology or do not use a smartphone said they are less likely to participate in a mobile clinical trial. Nearly half of respondents reported that they would not participate in a trial if there were no guarantees that their data would remain confidential, while others expressed concern about seeing a doctor less frequently in a mobile clinical trial setting.

CTTI’s findings contributed to the development of recently-announced recommendations and resources that help the research enterprise maximize the opportunities of mobile technologies to advance the development of new medical products. Related work and resources can be found as part of CTTI’s broader Mobile Clinical Trial program.

CTTI Unveils New Database of Feasibility Studies on Mobile Technologies in Clinical Research

Posted on by Lorri Bingham

Mobile technologies present exciting opportunities for researchers to monitor participants outside of the clinical setting. However, with new solutions entering the market daily, it can be challenging to decide which technology option will be most effective for a particular trial.

To help stakeholders address this issue, CTTI has established a searchable online database of pilot studies that assess the feasibility of various mobile technology solutions. The Interactive Database of Feasibility Studies for Mobile Clinical Trials, part of CTTI’s Mobile Clinical Trials Program, is the first publicly available resource that contains a catalogue of published feasibility studies related to the use of mobile technologies in clinical research.

A CTTI manuscript recently published in npj Digital Medicine, describes how this tool will enable sponsors and researchers to capitalize on information gained from 275 previous pilot studies to reduce risk and optimize the effective use of wearables and other devices in clinical trials. The database will allow users to search by therapeutic area, technology type, participant characteristics, and other variables to explore a range of issues surrounding mobile technology, such as sensor performance and algorithm development.

“We are excited about the opportunities presented by this new resource,” said CTTI Executive Director Pamela Tenaerts. “CTTI is continually striving to provide relevant recommendations surrounding the rapidly changing field of mobile technology. The database aligns nicely with CTTI’s comprehensive set of resources that will help stakeholders adopt mobile technologies to make clinical trials more effective.”

Resources from CTTI extend beyond the database—it also has created a set of recommendations and a tool that can be used to select mobile technologies for data capture in clinical trials.

CTTI plans to regularly maintain and update the database to give online users easy access to the most current knowledge on the use of mobile technologies in clinical trials. Viewers can also help grow the resource by submitting a paper to the database.

Webinar Now Available: CTTI’s New Recommendations for Engaging Patients and Sites in Mobile Trials

Posted on by Lorri Bingham

A recording is now available of the public webinar on Thurs., Feb. 21, to launch CTTI’s new recommendations for incorporating patient and site perspectives in mobile clinical trials. The webinar was led by patient advocate Cindy Geoghegan and Virginia Nido of Genentech, a member of the Roche Group.

CTTI conducted qualitative and quantitative research to better understand the perceptions of patients and site personnel, and convened experts and leaders across the clinical trials enterprise to develop actionable recommendations and resources.

“Patients are attracted to the possibilities of greater convenience and greater access to clinical research—fewer visits, less time away from work and family, and less burden on their caregivers,” Geoghegan said. “Our goal was to enhance the experience for both patients and hard-working site staff.”

The resulting recommendations are designed to help research sponsors engage patient and site perspectives in planning mobile trials, maximize value and minimize burden for study participants, and address challenges for investigative sites.

“One of the key messages is the importance of planning,” Nido said. “We are new to this as an industry, and we need to plan for and address these new challenges in order to maximize the benefits of mobile technology in clinical trials.”

This is the final of four sets of recommendations CTTI has released as part of its Mobile Clinical Trials (MCT) Program. In 2017, CTTI announced recommendations for developing novel endpoints generated by mobile technologies and, in 2018, it unveiled new solutions for using mobile technologies for data capture in clinical trials, and recommendations for using decentralized clinical trials. Additionally, they build on previous CTTI work—including our Quality by Design and Patient Groups and Clinical Trials recommendations—that emphasizes the involvement of many stakeholders, including patients and sites, in trial design.

CTTI Unveils New Recommendations for Incorporating Patient and Site Perspectives in Mobile Trials

Posted on by Lorri Bingham

CTTI released new recommendations and resources today for engaging patients and sites when planning clinical trials using mobile technologies. These recommendations have the potential to help sponsors, CROs, and other stakeholders gain the full benefits of using mobile technologies in clinical trials, including remote participation, increased protocol adherence, and participation by a more diverse population.

While buy-in from stakeholders is critical to the success of mobile trials, little was known about patient and site perspectives until CTTI conducted surveys and interviews with patients and investigative site personnel to assess perceived benefits and barriers.

Engaging Patients and Sites Recommendations

The resulting recommendations have the potential to help research sponsors:

  • Engage patients and sites in protocol design, technology selection, and pilot testing
  • Maximize value and minimize burden for study participants by setting patient expectations, protecting privacy, returning data, enhancing patient-site interactions, and providing technical support
  • Address challenges for investigative sites, from contracting and budgeting to evaluating site readiness and implementing effective and streamlined training

“CTTI’s recommendations and resources are designed to take our understanding of patient and site needs in mobile clinical trials to the next level,” said Bill Wood, associate professor at the School of Medicine at the University of North Carolina at Chapel Hill. “With these new insights, sponsors and researchers can plan and conduct mobile trials that work better for everyone involved, streamlining the clinical research process and accelerating the development of critical new therapies.”

The recommendations are the fourth set generated through CTTI’s Mobile Clinical Trials (MCT) Program, following recommendations on developing novel endpoints generated by mobile technologies, using mobile technologies for data capture in clinical trials, and planning and conducting decentralized clinical trials. Additionally, they build on previous CTTI work—including our Quality by Design and Patients Groups and Clinical Trials recommendations—that emphasizes the involvement of many stakeholders, including patients and sites, in trial design.

CTTI to Launch Recommendations for Engaging Patient and Site Perspectives in Mobile Clinical Trials

Posted on by Lorri Bingham

CTTI will host a public webinar on Thurs., Feb. 21, to announce new recommendations and resources for incorporating patient and site perspectives when planning and conducting mobile clinical trials.

“Acceptance and adoption by key stakeholders is critical to the widespread use of mobile technologies in clinical trials,” said CTTI Executive Director Pamela Tenaerts. “However, very little was known about patient and sites’ perspectives until our work shed light on what they see as significant benefits and barriers. Our new recommendations account for these perspectives and provide a valuable resource for optimally deploying mobile clinical trials.

“Further, they build on previous CTTI work—including our Quality by Design and Patient Groups and Clinical Trials recommendations—that emphasizes the involvement of many stakeholders, including patients and sites, in trial design. Engaging these groups early and often is the key to running better trials.”

CTTI conducted surveys and in-depth interviews to better understand the perceptions of patients and clinical investigators, and convened experts and leaders across the clinical trials enterprise to develop actionable recommendations and resources.

The resulting recommendations are designed to assist research sponsors in:

  • Engaging patient and site perspectives in planning clinical trials using mobile technologies, including protocol design, technology selection, and pilot testing
  • Maximizing value and minimizing burden for study participants, including setting patient expectations, protecting privacy, returning individual data, enhancing patient-site interactions, and providing technical support
  • Addressing challenges for investigative sites, from contracting and budgeting to evaluating site readiness and implementing effective and streamlined training

This is the final of four sets of recommendations CTTI has released as part of its Mobile Clinical Trials (MCT) Program. In 2017, CTTI announced recommendations for developing novel endpoints generated by mobile technologies and, in 2018, it unveiled new solutions for using mobile technologies for data capture in clinical trials, and recommendations for planning and conducting decentralized clinical trials.

The free webinar will begin at noon ET and will be led by patient advocate Cindy Geoghegan and Virginia Nido of Genentech, a member of the Roche Group.