Digital-First Trials: Partnership, Engagement and Patient Data Return

Patient centricity has long been a guiding principle in clinical research, but for years, it remained more of an aspiration than an operational reality. Early initiatives like the James Lind Alliance (2004) and regulatory bodies such as PCORI helped embed patient perspectives into research frameworks, but the industry has struggled to translate these ideals into tangible, measurable improvements.

Now, the tide is turning - not because of industry ambition alone, but because patients themselves are demanding more. They seek active participation in clinical trials, access to their data, and a clear understanding of how their contributions impact medical advancements.

Many participants of modern clinical trials are not passive subjects; they are informed, digitally fluent, data-conscious stakeholders who expect a greater level of education and transparency within their patient experience, including access to their individual patient data.

For sponsors, this shift represents both an opportunity and a challenge. Digital transformation and patient engagement technologies now make it possible to quantify and operationalize patient centricity, bridging the gap between intention and execution.

We know poor patient experiences can lead to waning trust, lower recruitment rates, and higher dropout levels. Sponsors must examine the technological, social and ethical forces driving change, and move beyond patient-first rhetoric to prioritize meaningful patient engagement initiatives.

Patients want to be engaged

The clinical trial model was historically sponsor-driven, site-executed, and patient-included. But that hierarchy has eroded.

Patients now expect - and are increasingly advocating for - a more collaborative role in clinical research. They want input on trial design and conduct and better communication channels for queries and concerns. They also want to see the resulting research data, understand it, and use it to inform their healthcare decisions: CISCRP research shows that 72% of patients voiced a strong interest in seeing their individual study data, and 90% agreed it was important to receive a summary of the research results. This challenges a long-held industry belief that patients might be overwhelmed by receiving their trial data.

Regulatory discussions have evolved in response to growing demands, with a push toward patient data return (PDR) - the practice of giving participants access to their personal trial data. Once seen as a logistical or compliance challenge, PDR is now recognized as both an ethical obligation and a competitive differentiator for sponsors.

Advances in digital technology solutions mean there is little validity in claims of operational, resource, or privacy constraints. A failure to provide meaningful transparency and engagement now risks alienating an increasingly informed and empowered patient base.

The business case for patient data return

Though ethics and people-first thinking rightfully inform key decisions, sponsors recognize that returning data to patients has direct, measurable business benefits far beyond altruism.

When patients feel valued and informed, they are more likely to stay engaged throughout the trial - reducing costly dropout rates and improving overall study efficiency. Giving participants access to their data fosters a stronger research partnership.

A pilot study published in BMJ Open found that returning both individual and aggregate trial data to participants increased patient satisfaction and that 42% shared the information with healthcare providers. This kind of transparency not only meets patient expectations but also builds long-term credibility for sponsors.

Patients who feel engaged and empowered are more likely to become advocates for future participation, improving recruitment efforts in the long term. For sponsors, this is the ROI of patient-centricity: a model where transparency and engagement drive scalable study success.

The role of user-centric technology 

The shift from passive participation to active engagement is made possible by digital transformation. AI-powered tools, mobile-first study platforms, and real-time analytics are removing friction points and turning patient-centric engagement into a measurable strategy.

The patient journey needs to be refined, end-to-end. A Deloitte report found that 92% of patients believe that improving experiences (such as through innovative technologies) should be a top priority.

Perhaps most importantly, these digital tools don’t just benefit patients - they support sites, too. Sites with real-time study visibility and streamlined workflows are better equipped to manage patient interactions efficiently, reducing administrative burden and improving compliance. By addressing site engagement in tandem, sponsors create a foundation for sustained patient involvement - improving trial retention and optimizing recruitment strategies. Our data shows that engaged sites perform better, recruiting >23% more patients than their non-engaged counterparts.

Moving from concept to execution

The industry is at an inflection point. Sponsors who move beyond high-level patient-centricity statements and implement data-driven engagement strategies will be leading the way for impactful stakeholder partnerships in clinical research.

And this isn’t just theory - Transcelerate’s participant data return initiative is actively working to develop standardized best practices for returning clinical trial data to participants. This industry-wide push shows that data return is set to be more than a renewed trend.

Sponsors that fail to adapt risk losing trust, facing recruitment challenges, and falling behind industry leaders already implementing these changes.

Transforming engagement into study success

At Teckro, we believe that patient-centricity is intrinsically tied to study performance, and as such, should be measurable and built around an engaging user experience. We deliver an integrated, real-time engagement ecosystem that benefits patients, sites, and sponsors.

Our digital patient experience enables:

Want to hear more?

Watch our on-demand webinar, "Patient-Centric Trials: The role of individual data return in better patient experiences", where we explore how technology is transforming patient engagement, the ethical and strategic case for returning data to patients, and what sponsors need to do next.