Flowchart: Steps For Novel Endpoint Development
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:
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.
Mobile technology has the potential to revolutionize clinical trials, but putting mobile clinical trials (MCTs) into action requires consideration of issues such as data integrity, legal and regulatory barriers, scientific and technological challenges, and perspectives of potential trial participants, investigators, and site staff. For the past two years, CTTI’s MCT Program has systematically explored barriers to MCTs, gathered evidence, and convened multiple stakeholders to tackle these issues.
By developing best practices on how to effectively integrate mobile technologies into clinical trials for regulatory submissions, CTTI intends to promote quality, efficient, and more cost-effective research. Recent developments include the following:
Mobile technologies, including both medical sensors and consumer products, offer exciting new possibilities for clinical research but present substantial challenges as well. Find out how CTTI’s Mobile Devices team is exploring how these technologies can be used to improve patient engagement, remote monitoring, and the collection of new kinds of high-quality, objective data capable of supporting rigorous analysis and regulatory submission.
In a webinar now available as a recording on the CTTI website, project team leaders Cheryl Grandinetti (FDA), Chris Miller (AstraZeneca), and Barry Peterson (Philips) provide an update on CTTI’s Mobile Devices Project, which focuses on scientific and technological challenges affecting the selection and use of mobile technologies in clinical research. The presenters share preliminary evidence gathered from research sponsors and clinical investigators experienced in using mobile devices in clinical trials. Issues addressed in the webinar include:
After additional evidence and insights from this project are gathered, the team will release recommendations designed to help overcome challenges that are currently hindering the wider use of mobile technologies in clinical trials.
The Mobile Devices Project is one of four distinct efforts taking place through CTTI’s larger Mobile Clinical Trials Program. The MCT Program is developing evidence-based recommendations to guide the widespread adoption and application of mobile technologies in clinical trials. The three other projects within the program are focused on:
CLICK HERE to view recordings of other CTTI-hosted webinars.