The imperative for patient centricity in clinical research in the Age of AI

As the Age of Artificial Intelligence (AI) and intelligent automation takes hold in the clinical trial industry, the imperative for patient centricity and stronger patient-site relationships is more relevant and critical than ever before. uMotif Chief Patient Officer and Co-Founder Bruce Hellman shares his perspective.

Reflections on 2025 and the year ahead

As I take stock of key developments in the clinical research industry in 2025 and what we might expect this year, I’m reminded of an important milestone our industry will mark in 2026: the 15th anniversary of the first fully decentralised clinical trial, Pfizer’s REMOTE study.

This model has been an important leap forward for clinical trials, expanding access for patients and improving their experience by enabling them to participate in research from their own homes. And it’s uplifting and encouraging that, a decade-and-a-half later, the industry is more focused than ever on easing the patient’s journey and how technology can best support that mission.

This past year, we saw expanded discussion around the importance of a strong patient-site relationship in a successful clinical trial journey. In the age of decentralised trials, which rely on digital technology and remote data capture, site personnel are the “face” and human element of a clinical trial for participants. Sites are heavily responsible for recruitment, consenting, and enrolling patients to get the trials started. It follows that a strong patient-site relationship is often the most critical factor in building trust as participants navigate a new world, and in fostering long-term engagement, compliance, and retention.

We’re seeing increased focus on ways to strengthen bonds and communication between patients and site personnel without adding more complexity for either party. Sites are increasingly burdened by a growing universe of clinical requirements and technology tools, which make their jobs exponentially more difficult. The industry is looking for and embracing tools such as eConsent, that can help to strengthen the patient-site relationship without adding new levels of complexity.

In tandem, there’s growing emphasis by sponsors and regulatory agencies on patient-reported experiences and outcomes, which are now considered in the approval process for most new therapeutics. Cancer drug clinical trials, for example, increasingly measure quality of life (QoL) alongside survival, and patient-reported data is essential to this metric.

To enable effective and efficient capture of experiential data, clinical trial technology developers must endeavour to infuse the patient mindset into design from day one. This means eCOA and ePRO technology must be easy to use and – in a best-case scenario – familiar. Understanding the importance of this connection, the industry is also beginning to increase its use of bring-your-own device (BYOD) for clinical trials.

And it’s impossible to assess 2025 without discussing the rapid ascent of AI and its potential application in clinical trials. There’s both tremendous optimism and a healthy dose of caution and scepticism, given the gravity of the industry’s work. While still in early days, AI initiatives show promise in speeding up documentation and configuration specifications, improving data quality, and enabling new insights.

At uMotif, we’re applying AI to make us more efficient, more consistent, and to deliver the highest quality for our customers and a superior experience for clinical trial participants. Operating in a highly-regulated industry in which patient safety is paramount, we’re ensuring that, when we build and deploy AI assistants, a human has the last say and is responsible for the trial’s integrity.

Hopes for the year(s) ahead

Our industry is highly regulated and cautious for good reason. As such, we typically experience evolutionary versus revolutionary change from one year to the next.

As an optimist, I expect that we’ll see in the year ahead and beyond an even greater focus on placing the humans participating in and orchestrating clinical trials at the forefront.

For participants, this means incorporating the patient perspective into every phase and aspect of the trial – study and assessment design, recruitment and consent, site visit frequency, data collection methodology and the technology used to capture it, and even post-trial communication and follow-up. We’ve observed that sometimes the simplest things – such as coordinating seamless transportation to the site and making sure that parking is as easy as possible – can have a huge impact on the patient experience and retention.

For site personnel, extension of the human-first approach might include greater collaboration in study design, as well as the incorporation of new tools that strengthen relationships with patients, while introducing new efficiencies for clinical professionals.

About the author

Bruce Hellman brings his passion for advancing patient-centricity in clinical trials and technology to his work at uMotif. Bruce co-founded uMotif in 2012, initially inspired to help patients with Parkinson’s Disease track and better manage their condition. As Chief Patient Officer, he applies a patient-centric lens to guide the continued evolution of uMotif’s modern eConsent and COA/ePRO platform and enable unrivaled engagement.

About uMotif

Putting patients first is in uMotif’s DNA. The modern uMotif eCOA platform delivers faster, high-quality clinical trials and real-world studies by putting patients at the core of research. Combined with uMotif’s robust site tools – including consent management, site productivity, and trial awareness – the platform strengthens the patient-site relationship, which is key to improving eCOA compliance and retention. With cloud hosting in the US, Europe, and China, the GCP, 21 CFR Part 11 and GDPR-compliant platform supports all study phases and indications. Visit www.umotif.com