Bringing Trial Activities to the Participant

The move toward more participant-centric clinical research has taken an important step forward.

At the Clinical Pharmacology & Therapeutics journal, the first papers from the RADIAL trial, the flagship study of the Trials@Home project have now been published, offering valuable insights into how clinical research can be effectively brought to participants’ homes.

The project set out to explore the opportunities, benefits, and challenges of moving beyond traditional site-based clinical trials toward decentralised and hybrid approaches, all while maintaining scientific rigor, participant safety, and regulatory compliance.

The Challenge: Rethinking the Traditional Clinical Trial Model

For decades, clinical trials have relied on participants visiting centralised research sites for every step—from screening and consenting to assessments and follow-up.

While this model has proven robust, it presents significant barriers to accessibility, inclusivity, and efficiency. Participants often face long travel times, scheduling constraints, and logistical burdens that can limit enrolment and retention.

As digital health technologies mature, a key question has emerged:
Can clinical trials be conducted safely and effectively from the participant’s home?

Addressing this question requires balancing innovation with regulatory and operational standards—ensuring that new models of research remain reliable, compliant, and participant-friendly.

A Multi-Arm Approach: Traditional, Remote, and Hybrid Designs

To explore this question, the RADIAL trial implemented a unique three-arm design comparing:

• Traditional (site-based) – all study activities conducted at research sites.

• Remote (fully decentralised) – participants completed all study tasks at home.

• Hybrid – a blend of site visits and remote participation.

Each arm was assessed according to key performance indicators related to safety, data quality, participant satisfaction, and operational efficiency.

Our organisation served as the core technology provider for the trial—helping enable remote assessments, data capture, and participant engagement tools across all trial configurations.

Key Findings: Proof of Feasibility and Value

Initial results from the RADIAL trial demonstrate that decentralised and hybrid models can be safe, effective, and participant-friendly, provided that technology and operational workflows are implemented thoughtfully.

Key takeaways include:

• Comparable data quality and safety were achieved across all trial arms, indicating that decentralised models can maintain high standards of integrity and compliance.

• Participant satisfaction was high in the remote and hybrid arms, highlighting the appeal of reduced travel and greater scheduling flexibility.

• Operational efficiency improved in several domains, though logistical and regulatory complexities require continued refinement.

These findings offer concrete evidence that clinical trial activities can indeed be brought to the participant—without compromising scientific or ethical standards.

Collaboration, Curiosity, and Impact

Our involvement in the Trials@Home project was guided by three core principles:

• Collaboration – Working in a consortium of leading pharmaceutical companies, technology providers, and academic partners allowed us to integrate diverse expertise spanning medical, regulatory, and ethical dimensions.

• Curiosity – Challenging traditional models of research delivery was essential to driving innovation and reimagining how clinical trials can operate.

• Impact – Our focus was always on where technology could add the greatest value—supporting, not replacing, the human aspects of clinical research.

Why This Matters

Decentralised and hybrid clinical trial models have the potential to transform how research is conducted globally. By making participation more accessible, inclusive, and flexible, these models can reduce barriers, enhance diversity in clinical research, and speed up the generation of meaningful evidence.

Validated technologies, robust protocols, and strong partnerships are key to scaling these innovations safely and effectively.

Implications and Future Directions

The publication of the RADIAL trial papers marks an important milestone, but the work continues. Future efforts will focus on:

• Optimising remote recruitment and consenting processes to ensure inclusivity and compliance.

• Refining technology solutions to further streamline data capture and monitoring.

• Building regulatory and operational frameworks that support widespread adoption of decentralised approaches.

By learning from the RADIAL experience, sponsors and CROs can design future studies that blend the best of both worlds—maintaining scientific rigor while putting participants at the center.

Conclusion

The RADIAL trial has demonstrated that bringing clinical research to participants’ homes is not only feasible but can enhance the quality, efficiency, and inclusivity of clinical trials.

As we continue to refine these approaches, we move closer to a future where participation in clinical research is more flexible, accessible, and human-centered—no matter where participants live.

We are proud to have contributed to this landmark initiative and look forward to helping our partners apply these learnings to shape the next generation of decentralised clinical trials.