2. Your core strategy
This section is where we construct your core strategy, creating a solid framework that makes your digital endpoints meaningful and feasible.
We’ll explore how to develop endpoints that are deeply informed by patient experiences, establish a precise context of use that ensures everything fits seamlessly, foster strong stakeholder alignment for smooth collaboration, and thoughtfully select the right sDHT while incorporating early validation to keep things on track.
As an adopter, you might begin with a pressing clinical or scientific need, like measuring subtle changes in mobility for a neurology trial, and then seek out technologies that can capture it accurately.
Adopters, you offer invaluable expertise in patient priorities, the nuances of clinical settings, and what regulators expect to see.
As a developer, you produce innovative tools and then may scout for endpoints or studies where they can deliver real value. The most powerful path forward is one of early collaboration.
Developers, you bring clarity on what’s measurable with reliability, how raw signals evolve into actionable endpoints, and the kind of evidence that builds trust.
Early collaboration creates a shared plan that minimizes redundant efforts, reduces validation risks, and sets you up for effective regulatory interactions. The FDA actively encourages this early engagement—sometimes at multiple touchpoints—to sharpen your questions and align on the evidence required.
Success comes from weaving together a clear, patient-relevant context of use; robust alignment among clinical, data, regulatory, and operational stakeholders; and technology that’s matched to measurement goals and trial realities.
SECTION 2 | YOUR CORE STRATEGY
Ready to dive in?
These subsections and resources will give you practical tips, best practices from the field, and point you to relevant sections of FDA guidances.
Define a precise context of use to ensure your measures are fit-for-purpose and clinically meaningful.
