Digital Health Technologies
CTTI Paper Features Recommendations for Incorporating Patient and Site Perspectives in Digital Health Trials
Digital health technologies offer the potential to improve the conduct of clinical trials. If harnessed correctly, they can reduce patient burden, streamline operations, and optimize data collection. The key to unlocking these benefits is to ensure that patient and site perspectives are considered during the planning process. CTTI has released a new manuscript in Contemporary Clinical Trials Communications that features the first evidence-based set of recommendations for incorporating patient and site perspectives in digital health trials.
CTTI’s comprehensive recommendations for planning trials using digital health technologies offer advice across several research study topics, including:
- Engaging patients and sites in planning clinical trials using digital health technology
- Maximizing value and minimizing burden for study participants
- Addressing challenges for investigative sites
This comprehensive set of recommendations was developed by first conducting a survey of 193 potential research participants regarding their willingness to use digital health technology in clinical trials as well as their preferences and concerns. Site experiences and preferences were captured through qualitative interviews with 12 different investigators. CTTI then collated this information and conducted an expert meeting over two days. Attendees, including patients, investigators, regulators, sponsors, and technology experts, presented key findings and discussed strategies and implications.
Because patients and site personnel offer important perspectives on how best to incorporate digital health technology into a trial, CTTI recommends their input be taken into account early and often. Ensuring their engagement helps stakeholders incorporate digital health technologies in the most efficient way possible, which can help to advance clinical trials and accelerate the development of new treatment options.
Read the full manuscript.
New CTTI Project Aims to Increase the Use of Clinical Trial Endpoints Derived from Digital Technologies
While digital health technologies (DHT) offer clinical trial researchers the promise of more efficient and potentially accurate data, there are very few examples of digitally derived primary endpoints that can support regulatory labeling claims.
To address this issue, CTTI is conducting a new project that will build on previous novel endpoint work to create additional resources and recommendations to drive the use of digitally derived, functional outcomes as key endpoints in clinical trials to support regulatory decision-making.
Once the project is complete, stakeholders can look forward to resources such as:
- Best practice recommendations on the “standards of evidence” needed to qualify a DHT-derived novel endpoint
- Glossary of terms for digital health endpoints
- Summary of interview results
- Expert meeting summary
CTTI will conduct glossary term evaluations, literature reviews, and landscape assessments – as well as in-depth interviews and multi-stakeholder expert meetings – to collect data that will inform the new recommendations and resources.
These solutions will serve to increase the use of meaningful DHT-derived novel endpoints in clinical trials for labeling claims and help to advance the benefits of running digital health trials, including the capture of more meaningful and higher quality research data.
CTTI Feasibility Studies Database Adds New Resources
CTTI has added 172 new studies to its Feasibility Studies database, bringing the total number of resources up to more than 440 studies. This free, one-of-a-kind repository of feasibility studies using digital health technologies to capture data in clinical research can help the entire clinical trials community to better match appropriate technologies to their research goals.
For example, sponsors can use the resource to help support trial design, while investigators in the field can use it to make decisions regarding which technology would be most useful for their research. This centralized repository could also help alleviate future development of redundant studies and contribute to the design and implementation of high quality, efficient trials.
The database includes a systematic search of scientific literature indexed in PubMed and published between January 2014 and June 2019.
Do you know about a study we should add to the database? CTTI invites others in the digital health trials community to submit relevant studies on an ongoing basis.
CTTI Mobile Tech Recommendations Featured in New Digital Biomarkers Article
The open access journal Digital Biomarkers published a new article this week featuring CTTI recommendations for the use of Mobile Technologies for Data Capture and Improved Clinical Trials. The article articulates the vision of using mobile technologies in clinical trials and highlights CTTI’s evidence-based solutions for using mobile technologies for more efficient assessment of new therapies for patients.
Mobile technologies such as wearables, ingestibles, implantables, portable sensors, and smartphones are designed to collect measures directly from an individual and could potentially contribute to a more complete picture of a patient’s experience in a clinical trial. This article offers recommendations for technology selection, data collection, analysis and interpretation, data management, protocol design and execution, and FDA submission and inspection.
Special Launch Event Recap: Using Mobile Technologies for Data Collection in Clinical Research
Experts Unveil New CTTI Recommendations and Resources at FDA’s White Oak Campus
During a daylong launch event at the U.S. Food and Drug Administration’s (FDA) White Oak Campus, more than 100 people—along with hundreds of virtual attendees—learned about CTTI’s newly release recommendations and resources for the use of mobile technologies in clinical trials.
The evidence-based recommendations and resources outline best practices for the use of mobile devices and applications to capture objective data—an approach that has the potential to increase the quality and efficiency of clinical trials.
More than 30 technology and clinical trials experts participated in sessions offering practical guidance, from selecting a mobile technology through to preparing for FDA submission and inspection. The event concluded with a lively panel on “The Future of Mobile Technologies in Clinical Trials,” where five leaders shared valuable reflections and predictions:
“A lot of what was discussed today is very much in line with the EMA’s position—the ‘rules’ are the same with data from mobile clinical trials and traditional trials, patient input is critical, and regulators should be engaged from the start of, and throughout a trial.” – Francesca Cerreta, European Medicines Agency
“One of the things I’m most excited about is that mobile technologies bring studies to participants, versus participants having to come to studies. And there’s opportunity to gather more pre- and post-intervention information than ever before.” – Ray Dorsey, University of Rochester
“There is a lot of interest in using mobile technologies in clinical trials and their potential to improve the quality and efficiency of clinical trials. This meeting is another step forward in exploring ways to incorporate mobile technologies into regulated clinical trials. I’m very encouraged by the sense of optimism from the many different sectors represented here today.” – Leonard Sacks, FDA
Pat Furlong, Parent Project Muscular Dystrophy, and John Hubbard, Genstar Capital, also joined Cerreta, Dorsey, and Sacks on the panel. They noted that CTTI’s new recommendations open the door to new opportunies for clinical tirals including improved patient engagement, better quality of data, and lower costs.