This Use Case describes findings from a unique approach to identifying risks and, more importantly, solutions when deploying digital clinical measures Health outcomes or physiological characteristics of an individual’s health, wellness, and/or condition that are collected digitally with a sensor. to support a labeling claim in a pivotal clinical trial.
Are you trying to identify whether your team is ready to rely on a digital endpoint Event or outcome that can be measured objectively to determine whether the intervention being studied is beneficial. in support of a new medical product? This dossier identifies the critical risks that you should be aware of, describes the root causes of these risks, and provides you with solutions to support your success.
The objectives of this Use Case are to:
- Discern between real and perceived risks associated with the inclusion of a digital endpoint to support a label claim
- Report findings from a pre-mortem exercise examining the root causes of hypothetical digital endpoint failure
- Focus your attention on risks that matter and help you and your team decide whether you are ready to successfully include a digital endpoint to support a label claim
Review this briefing document for a summary of critical risks when using a digital endpoint to support a labeling claim and the variety of strategies you can use to mitigate these risks and support your success. View the poster here.
Pro tip: the poster is in Miro, a collaboration software. Take this 2 min tutorial to learn how to navigate through the board an access all the useful information easily.
Dive deeper into the whiteboards developed real time in the workshop for each category:
- Technology and vendor selection from the pre-mortem. View here.
- Data quality and data management selection. View here.
- Study design. View here.
- Ops and maintenance. View here.
Pro tip: the poster is in Miro, a collaboration software. Take this 2 min tutorial to learn how to navigate through the board an access all the useful information easily
View the Pre-Mortem cheat sheet below for all you need to now about our Pre-Mortem process.
Meet all the experts that participated in the Pre-Mortem workshop here.
ICYMI Listen to the panel of experts from this Tour of Duty who collaborated to create the resources in this Dossier as they share their perspectives on the challenges and the opportunities to advance the use of digital clinical measures (excerpted from our launch event on April 30, 2021).