How can digital health technologies improve clinical trials?: A strategic framework for innovation

What benefits do digital health technologies bring to clinical trials?

Global regulators, including the FDA, are increasingly supportive of digital health technologies (DHTs) because they can meaningfully enhance how clinical trials are designed and run. These tools reduce patient burden through remote monitoring, make it possible to explore novel endpoints and digital biomarkers and allow sponsors to collect richer real‑world data across more diverse populations. They also offer opportunities to improve trial inclusivity and streamline operational processes.

While the benefits are clear, implementing DHT-enabled clinical trials often raises questions such as:

• Which endpoints should we measure – and how?
• What technologies are validated, scalable and user-friendly?
• How do we balance patient engagement and innovation with regulatory compliance?
• And ultimately, will patients and clinicians actually adopt these tools?

How do you help companies overcome these challenges?

We’ve developed a six-stage framework to guide organisations through clinical trial innovation, from early exploration to actionable strategy.

Stage 1: Direction-Setting

Q: Where do we start?

Every project begins with alignment and exploration of drivers for innovation: Are you aiming to differentiate through a clinical trial? Improve access? Capture new measures?

Understanding the “why” behind innovation is the first step toward doing it well. Involving cross-functional experts in clinical, technical, regulatory and patient engagement is key to clarify your project’s goals, potential constraints and criteria for success.

Stage 2: Clinical Strategy Development

Q: What should we measure and why?

This stage defines meaningful endpoints and explores digital biomarkers. We map the trial phases and patient journey, assess hybrid or decentralised models and combine research with expert interviews and patient insights to ensure strategies are grounded in science and aligned with the context of use.

Stage 3: Technical Assessment

Q: Which technologies are right for us?

DHTs range from wearables and sensors to apps, platforms and digital biomarkers, but not all are fit for use in every clinical trial.

Integrating a DHT into a trial has the potential for increased protocol complexity and trial site burden as well as challenges with managing lost or non-functioning kit, technical integration and delays in implementation if the technology is not already compatible with your chosen electronic data capture/clinical data management system.

Assessing your chosen DHT early, in plenty of time before your trial – and thinking beyond the device or app to consider the end-to-end system will ensure things like trial site interaction, additional support and training requirements, technical integration and data flow and capture have all been considered in plenty of time.

To help our clients find the right technologies for them, we conduct rigorous reviews of existing and emerging solutions, assessing:

• Clinical validation and regulatory status
• Technical performance and data integrity
• Usability and patient experience
• Integration with existing digital platforms and systems
• Interaction with site workflows and operations
• Fit with your specific endpoint strategy

We’ve bench-tested wearables, conducted usability studies and evaluated digital platforms across a wide range of therapeutic areas. Our deep engineering and UX expertise allows us to assess technologies with a critical, experienced eye.

Stage 4: User Engagement

Q: Will patients and clinicians actually use these tools?

Alongside technical assessment it is critical to explore whether technologies and trial designs will be acceptable, usable and engaging for different stakeholders.

A DHT only delivers value if patients and clinicians actually use it – and engagement and adherence are influenced by:

• Ease of use and accessibility
• Relevance to patient needs
• Perceived benefit
• Burden within daily life

Even well-designed tools can experience drop-off in usage, poor adherence or incomplete or biased datasets – and the longer the clinical trial, or higher the user burden – the more challenging it may become to retain engagement with the DHT within the trial.

We analyse patient characteristics, identify barriers to engagement and adherence and explore strategies for digital adoption, all while considering regulatory and operational constraints. This ensures innovation is practical and implementable.

Stage 5: Cost-benefit analysis

Q: Can we justify the investment in these tools?

Implementing any new technology is costly and will require justification.

To secure buy-in from senior stakeholders, it is often required to clearly articulate:

• Clinical value (e.g. better endpoints, improved outcomes)
• Operational value (e.g. efficiency, reduced site burden)
• Strategic value (e.g. differentiation, future capability)

Integration of DHTs in clinical trials is still in its infancy and there is limited real-world evidence of their success. Value is often difficult to quantify upfront, can be spread across multiple functions and is dependent on (often vague) assumptions.

We help you understand and define the value the digital tool will bring to your patients and your clinical trial, including defining assumptions around which to model economic evaluations and help to build the business case. This will help to create justification for the appropriate solution and bring senior management onboard with the investment.

Stage 6: Strategy Definition

Q: How do we turn insights into action?

We deliver a clear, actionable strategy outlining:

• Recommended technologies and configurations
• Trade-offs and risks
• Next steps for validation, piloting, or development
• Opportunities for differentiation and value creation

Whether you’re ready to move forward with a new vendor, adapt an existing tool, or explore custom development, we help you to de-risk and make informed, confident decisions.

What’s your key advice for companies exploring digital innovation?

Start early. Think holistically. Don’t just look for a tool, build a strategy. Leaving digital strategy too late often means trial protocols are locked and options are limited. Early planning unlocks value, reduces risk and delivers better outcomes for patients and sponsors.