2.3 Stakeholder alignment
As your endpoints and context of use take shape, the strength of your sDHT strategy depends on the people who bring it to life.
Stakeholder alignment ensures that clinical, patient, technical, operational, and regulatory perspectives are considered together rather than in isolation. When these viewpoints are intentionally aligned early, teams can surface assumptions, identify constraints, and converge on decisions that are both meaningful and feasible. This step builds resilience into your approach, reducing downstream rework and supporting confident progression as evidence expectations evolve.
OVERVIEW
The need for intentional collaboration
sDHT adoption requires coordination across diverse areas of expertise.
Clinical teams define how endpoints should be interpreted and used in decision-making.
Developers understand how technologies perform under real-world conditions and where limitations exist.
Operations teams evaluate whether a strategy can be implemented consistently across sites.
Patients and caregivers articulate what aspects of health matter most in daily life.
Data science and biostatistics teams assess analytic feasibility and support interpretability.
Regulatory stakeholders help clarify evidentiary expectations and identify potential gaps.
Without intentional alignment, these perspectives can diverge, leading to fragmented strategies or late-stage surprises. Creating space for structured dialogue—through workshops, interviews, or written inputs—helps teams integrate these viewpoints into a shared understanding of the endpoint and its role in the trial.
Adopters often carry decision-making authority regarding whether and how an sDHT is used in a study. Developers, however, bring essential contextual knowledge about the technology and must be engaged early to inform feasibility, scope MCID assumptions appropriately, and support coherent validation and implementation planning. Alignment at this stage sets the foundation for productive collaboration throughout development.
IN PRACTICE
Alignment requires deliberate actions
Start by identifying your core stakeholders—clinical leads for endpoint relevance, regulatory for evidentiary standards, data experts for processing, operations for feasibility, and patient partners for lived insights—and outline their contributions.
Organize targeted sessions, perhaps using agendas that focus on shared goals like refining the COU or addressing risks. Tools such as alignment checklists or collaborative platforms can keep discussions focused and actionable, while follow-ups ensure accountability.
Address challenges, like differing priorities, as opportunities to iterate, perhaps by prioritizing patient-centered criteria to guide resolutions. This ongoing process not only minimizes silos but also cultivates a team dynamic that adapts as your strategy evolves.
Who needs to be aligned, and why?
Effective stakeholder alignment begins with identifying the perspectives that materially influence endpoint success and engaging them at the right depth and time.
At a minimum, teams should consider alignment across the following groups:
Clinical leads and investigators, who evaluate clinical relevance, interpretability, and fit within trial workflows.
Patients and caregivers, who define which aspects of health are meaningful and help assess whether proposed endpoints and data collection approaches reflect real-world experience and acceptable burden.
Developers, who provide insight into what the sDHT can reliably measure, how algorithms behave in practice, and what optimization or validation work remains.
Data science, biostatistics, and COA experts, who assess whether concepts of interest can be translated into analyzable endpoints and integrated into the statistical analysis plan.
Clinical operations and quality teams, who determine whether the endpoint can be implemented consistently across sites and participant populations.
Regulatory and ethics stakeholders, who help clarify evidentiary expectations and identify areas of regulatory uncertainty early.
The objective is not to engage all stakeholders simultaneously or equally, but to ensure that each perspective informs decisions at the point where it can meaningfully reduce risk or improve alignment.
Essential partners: patients and caregivers
Patient and caregiver input plays a critical role throughout endpoint refinement, not only during early discovery. As candidate endpoints are translated into measurable concepts, patient perspectives help teams assess whether proposed measures reflect meaningful change, impose acceptable burden, and align with lived experience.
Practically, this may involve validating assumptions about what constitutes meaningful improvement, reviewing the burden associated with wearing or interacting with an sDHT, and pressure-testing clinical interpretations of digital signals. Revisiting patient input as endpoints evolve helps prevent misalignment between technical feasibility and real-world relevance.
Essential partners: regulatory stakeholders
Regulatory stakeholders are another key perspective in stakeholder alignment. Their feedback can shape scientific, operational, and strategic decisions, particularly as endpoints move closer to confirmatory use.
Early engagement can help clarify evidentiary expectations, reduce uncertainty, and avoid costly rework. Involving regulatory input alongside clinical, patient, data, and operational perspectives supports a more complete view of readiness and risk.
What to do now?
Include regulatory leads or liaisons in your stakeholder mapping and engagement plans. As you build alignment, note specific regulatory questions or uncertainties—these can be addressed via targeted, early check-ins with agencies.
Recognize that the “right time” and “right format” for regulatory engagement depends on your team’s maturity and evidence gaps. For many, a brief “sanity check” with FDA or analogous regulators is prudent before locking budgets, protocols, or major investment decisions.
FDA SPOTLIGHT
“In regulatory decision-making, FDA evaluates how well results of a COA-based endpoint correspond to a treatment benefit that is meaningful to patients… FDA strongly recommends that sponsors seek FDA input as early as possible regarding the evaluation of meaningful treatment benefit.”
– Section III (Evaluating the Meaningfulness of Treatment Benefit), p. 18
PRO TIP
Learn more: For detailed guidance on regulatory engagement pathways (including informal and formal options, checklists, and real-world examples), see Section 3: Engage regulators.
EXAMPLE COLLABORATION STRATEGY
The estimand workshop
Rooted in the ICH E9(R1) framework, an estimand workshop is one structured approach to aligning stakeholders on what a digital endpoint is intended to demonstrate and how it will be interpreted.
Effective estimand-focused alignment sessions help teams:
- Align on how the digital endpoint reflects patient benefit
- Surface differing assumptions across clinical, statistical, patient, and technical perspectives
- Support development of the SAP, MCID justification, and validation plans
- Ensure consistency with the defined context of use and traceability documentation
Not every organization will convene a formal workshop. Alternative approaches, such as short stakeholder interviews, written input from function leads, or review by a designated clinical or statistical champion, can still promote shared understanding and reduce siloed decision-making. The goal remains the same: to ensure that endpoints are patient-focused, clinically interpretable, and analytically defensible.
KEY TAKEAWAYS
Effective stakeholder alignment supports a coordinated sDHT strategy by integrating patient relevance, technical feasibility, operational readiness, and regulatory expectations. Bringing the right voices together early helps surface assumptions, reduce downstream rework, and ensure endpoints remain clearly defined and traceable to meaningful treatment benefit.
Identify and document core internal and external stakeholders early, including patients, clinical leads, developers, data experts, operations, and regulatory liaisons.
Establish intentional forums for alignment that focus on shared understanding of the endpoint and context of use.
Engage developers early to assess feasibility, analytic capabilities, and validation expectations.
Incorporate patient and regulatory perspectives into planning and document key questions for early, targeted engagement.
Use structured approaches, such as estimand-focused discussions or stakeholder mapping, to maintain alignment as the strategy evolves.
2.3 Stakeholder alignment
Library resources to guide you
The sDHT roadmap library gathers 200+ external resources to support the adoption of sensor-based digital health technologies. To help you apply the concepts in this section, we’ve curated specific spotlights that provide direct access to critical guidance and real-world examples, helping you move from strategy to implementation.
Features essential guidance, publications, and communications from regulatory bodies relevant to this section. Use these resources to inform your regulatory strategy and ensure compliance.
Gathers real-world examples, case studies, best practices, and lessons learned from peers and leaders in the field relevant to this section. Use these insights to accelerate your work and avoid common pitfalls.