What is a hybrid clinical trial?
A hybrid clinical trial integrates traditional site-based activities with decentralized and digital elements like telemedicine, eConsent, and remote patient monitoring. In 2024, as the industry evaluated the lessons learned from fully virtual models, hybrid trials became the preferred path forward—balancing innovation with practicality.
From Decentralized to Hybrid: The 2024 Turning Point
The momentum behind decentralized clinical trials (DCTs) accelerated during the COVID-19 pandemic. However, by 2024, biopharma sponsors recognized the limitations of a fully virtual approach—especially for complex therapeutic areas, in-person procedures, and global regulatory compliance.
Enter the hybrid model.
Hybrid clinical trials became the go-to strategy for trials requiring both in-person and remote components, allowing sponsors to extend geographic reach, reduce patient burden, and improve data quality—while maintaining the structure and oversight of site-based research.
Key Drivers in 2024 That Propelled Hybrid Trials
Patient-Centricity Meets Operational Reality
Sponsors wanted to offer more flexibility to patients, but not at the expense of oversight or compliance. Hybrid trials allowed home-based options like ePROs and nurse visits, while still involving investigative sites for complex assessments.
Evolving Regulatory Guidance
Agencies like the EMA, MHRA, and FDA issued clearer guidance in 2024 on hybrid trial conduct—supporting remote consent, telehealth, and real-world evidence collection—giving sponsors more confidence in designing compliant, patient-friendly protocols.
Technology Consolidation
2024 saw CROs and platforms investing heavily in integrating eConsent, EDC, telemedicine, and wearable data into centralized systems. This interoperability was essential for seamless hybrid execution.
Access and Equity Challenges
Hybrid trials helped overcome site-access challenges in underserved or rural regions. This was especially critical in oncology, rare diseases, and aging populations where travel was a burden.
Where Hybrid Trials Excelled in 2024
- Oncology: Site-based infusions paired with virtual follow-ups
- Rare disease: Broader access to global, treatment-naïve populations
- Neurology & psychiatry: Remote assessments using digital biomarkers
- Post-approval studies: Long-term monitoring via apps and wearables
Industry Adoption and Strategic Shift
Biotech sponsors especially embraced hybrid trials to mitigate budget constraints, minimize delays, and accelerate clinical milestones.
Challenges That Still Required Careful Navigation
While hybrid trials offered flexibility and efficiency, they were not without complexity:
- Site burden from managing both digital and physical workflows
- Training gaps in tech adoption among staff and patients
- Data fragmentation, if not well-integrated across platforms
- Varying international regulations for remote data and consent
The most successful trials in 2024 had one thing in common: they were supported by experienced CROs who could balance technology with clinical rigor.
2024 was the year hybrid trials became the new standard.
As the biotech and pharma industry looked to modernize clinical development, hybrid models delivered a proven, pragmatic solution. They addressed the shortcomings of fully decentralized models while meeting sponsor needs for scale, oversight, and speed.
Looking ahead, hybrid trials will remain central to strategies that prioritize patient access, accelerate development timelines, and meet global regulatory demands.