A recording of CTTI’s public webinar on “Next Steps for Obtaining Novel Endpoint Reliability & Acceptance” is now available.

During the webinar, presenters Lindsay Kehoe (CTTI) and Alicia Staley (Medidata) discussed CTTI’s current work to obtain reliability and acceptance of meaningful, digitally derived novel endpoints – a project that builds on CTTI’s existing novel endpoint development recommendations and resources from 2017. They also provided:

• Highlights from a recent Expert Meeting of leaders and stakeholders from across the clinical trials ecosystem
• Insights from in-depth interviews with sponsors
• A preview of the forthcoming set of CTTI novel endpoint recommendations and resources

This webinar built on recent webinars by DiMe, which focused on the best resources currently available for using digitally derived endpoints, and TransCelerate, which demonstrated key considerations and challenges for developing novel digital endpoints through a hypothetical case study.

“As the novel endpoints space continues to evolve, CTTI, DiMe, and TransCelerate are committed to working together to help stakeholders across the clinical trials enterprise evolve with it,” said Kehoe. “By encouraging greater collaboration and innovation among technology companies, academic investigators, patients, regulators, and trial sponsors and sites, we can accelerate progress to the benefit of everyone involved.”

For more on CTTI’s work around Novel Endpoints, please visit CTTI’s website.

On Oct. 5 at noon ET, the Clinical Trials Transformation Initiative (CTTI) will host a public webinar on “Next Steps for Obtaining Novel Endpoint Reliability & Acceptance” – the third in a series of webinars on using novel digitally derived endpoints in clinical trials for medical product development from CTTI, Digital Medicine Society (DiMe), and TransCelerate.

Presenters Lindsay Kehoe, CTTI, and Alicia Staley, Medidata, will discuss CTTI’s current work to obtain reliability and acceptance of meaningful, digitally derived novel endpoints – a project that builds on its existing novel endpoint development recommendations and resources from 2017.

Attendees will hear:

• Highlights from a recent Expert Meeting of leaders and stakeholders from across the clinical trials ecosystem
• Insights from in-depth interviews with sponsors
• A preview of the forthcoming set of CTTI novel endpoint recommendations and resources.

This webinar builds on recent webinars by DiMe, which focused on the best resources currently available for using digitally derived endpoints, and TransCelerate, which demonstrate key considerations and challenges for developing novel digital endpoints through a hypothetical case study.

“As the novel endpoints space continues to evolve, CTTI, DiMe and TransCelerate are committed to working together to help stakeholders across the clinical trials enterprise evolve with it,” said Kehoe. “By encouraging greater collaboration and innovation among technology companies, academic investigators, patients, regulators and trial sponsors and sites, we can accelerate progress to the benefit of everyone involved.”

Register to attend “Next Steps for Obtaining Novel Endpoint Reliability & Acceptance” today.

Despite the increased use of digital health technologies (DHTs) in trials over the past several years, few examples of a digitally-derived primary endpoint exist today. Working to fill this gap, CTTI held an “Obtaining Novel Endpoint Reliability & Acceptance” Expert Meeting on July 27-28 to inform its new recommendations and resources for driving novel endpoint acceptance.

Attendees discussed challenges and potential solutions to advancing the practical use of novel, digitally derived endpoints in clinical trials. They also uncovered and agreed on some important common themes:

• The Time is Now. Digitally derived endpoints have the ability to capture information that is more reflective of how patients feel and function in their day-to-day lives – but many factors hinder their acceptance. Collaborative partnerships and solutions that increase the understanding and use of DHT-derived endpoints are needed to make this happen.
• Fit-for-Purpose is a Must. DHT-derived endpoints need to be based on the specific context of use and validly measure a concept of interest in a way that is accurate, interpretable, and not misleading.
• “Meaningful” in More than One Way. To develop a DHT-derived endpoint, have the community – including patients and clinicians – discuss what constitutes “meaningful” change. A meaningful measure should show treatment benefit as well as clinical benefit.
• Engage Early and Often. Engage patients, investigative site personnel, and the FDA early and often when planning; involve biostatisticians and data scientists, as appropriate, in decisions regarding protocol design, data collection, analysis, and interpretation
• Validate, Validate, Validate. It’s important to remember that validating a device is a separate, yet parallel, process from validating the clinical measure. It is also especially important to demonstrate analytical validation of DHT algorithms within the specific patient populations.

This meeting and its findings, part of CTTI’s Novel Endpoint Acceptance project, will help expand CTTI’s 2017 Novel Endpoint work, which produced a set of recommendations, flowchart, detailed steps, and many other resources for developing novel endpoints.

For a preview of CTTI’s expanded set of novel endpoints recommendations and resources, register to attend its Oct. 5 “Next Steps for Obtaining Novel Endpoint Reliability & Acceptance” webinar.