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Hybrid Trials vs Remote Trials: Choosing the Right Trial Model

Shauni Fitzgerald
Published : April 16, 2025

As a result of advances in digital technology, the adoption of telemedicine in clinical trials, and changing participant expectations, decentralized clinical trials (DCTs) are becoming increasingly common clinical research models. Although the first entirely decentralized trials took place in 2011, they’ve been more intensively used since 2022. 

DCT clinical trial models like hybrid trials and remote trials are being embraced by industries ranging from nutraceuticals to medical devices, cosmetics, or pharmaceuticals. The move towards tech-enabled and patient-centric trials is transforming how clinical studies are designed and executed, making the choice of model more important than ever. 

Understanding the differences between hybrid vs remote trials is vital to optimize costs and reliability based on product type and study goals, as well as to ensure participant engagement and retention and to meet regulatory requirements. 

In this blog, we’ll explore what is the difference between hybrid and remote clinical trials, how these types of clinical trial models perform in data integrity, compliance, and participant retention, their respective advantages and limitations, and how to decide which model best suits a specific trial.

Table of Contents

 

Defining the Trial Models

i. What Are Remote (Decentralized) Clinical Trials?

Remote clinical trials, also known as fully decentralized clinical trials (DCTs), have a completely virtual design where all participant activities take place off-site. There are no in-person visits to trial sites, since these studies rely on digital tech to enable participation, data collection, and communication.

 

DCTs are therefore technology-driven, making use of tools like: 

  • eConsent platforms, which allow participants to view and sign consent forms digitally and remotely. These platforms can also feature interactive educational elements to clarify complex concepts and ensure all participants are fully knowledgeable and informed. 
     
  • Telemedicine in clinical trials for real-time communication, eligibility screening, and remote health checks. 
     
  • Mobile apps for real-time symptom tracking, digital diary entries, or to register patient-reported outcomes. These apps can also include push notifications with reminders for better protocol adherence.

  • Wearable devices can collect health data remotely on an ongoing basis, which can improve data richness and accuracy.

 

These tools enable a seamless participant experience while maintaining protocol fidelity, making remote clinical trial models ideal for nutraceutical studies focused on dietary or lifestyle interventions, consumer health products with minimal risk profiles, short-duration studies with minimal site visit requirements, and for trials involving geographically diverse or mobility-limited populations.

 

However, remote clinical research models have limitations. For instance, not all endpoints can be measured remotely, and there might be barriers to participation in populations with low digital literacy or limited Internet access. In addition, regulations concerning eConsent and data privacy issues aren’t standardized across the globe.

 

ii. What Are Hybrid Clinical Trials?

Hybrid clinical trials combine on-site and remote elements. For example, participants may visit a site for baseline assessments or medical device training, but they complete all follow-ups and symptom reporting virtually using telehealth or mobile apps.

 

By blending on and off-site elements, hybrid clinical trials offer exceptional flexibility in protocol design and execution. Due to this, they’re useful across multiple product categories, ranging from medical devices to cosmetics, and including pharmaceuticals and nutraceuticals.

 

Key Differences Between Hybrid & Remote Trials

Understanding the difference between hybrid and remote clinical trials is essential for trial design optimization. Here’s how they compare across several critical dimensions: 

 

i. Patient Engagement & Retention

Remote clinical trials maximize participant convenience by reducing travel requirements. However, this model can introduce challenges around retention, especially when participants feel disengaged from the study process.  

On the other hand, hybrid clinical trials maintain the convenience of remote participation while introducing an element of human interaction, which can improve trust and retention, especially in longer or more complex studies.

 

ii. Site Involvement & Logistics

Remote trials eliminate site visits, reducing barriers to participation linked to location or travel requirements. 

Since hybrid trials require coordination between sites and remote systems, they have an added level of logistical complexity.

 

iii. Technology Requirements

Remote clinical trials are tech-intensive, relying on one or multiple digital tools for data collection, transmission, and analysis. This can include electronic patient-reported outcome (ePRO) platforms, electronic data capture (EDC) systems, telehealth platforms, logistics software, and secure data storage.

 

Hybrid trials don’t require the same level of digital infrastructure, although this depends on protocol design. Typical tech requirements for hybrid decentralized clinical trials may include scheduling software, wearables, and patient portals.

 

iv. Data Collection & Integrity

Remote trials rely heavily on self-reported data, which makes collection and integrity subject to variability due to inconsistencies in participant adherence, device functioning, etc. As for hybrid trials, they may benefit from higher data integrity for certain endpoints that are measured via clinical-grade assessments.

 

v. Regulatory Considerations

Both clinical research models must comply with regulatory frameworks. In the U.S., the latest FDA guidance on Decentralized Clinical Trials (DCTs) highlights the need for validated technologies and compliance with existing electronic system requirements, such as 21 CFR Part 11. Under this guidance, all DCTs must have consent and product administration performed by qualified staff. 

In Europe, the EMA has issued its “Guideline on computerized systems and electronic data in clinical trials”. While also emphasizing data integrity, security, and systems validation, each EU country has its own ethics approvals process for these types of clinical trial models, whereas the FDA process is more centralized.

 

vi. Cost Implications

Remote trials can reduce costs by eliminating site expenses and streamlining recruitment. On the other hand, hybrid trials may involve higher upfront expenses, but their overall costs may be lower if they achieve better retention and higher data quality.

 

Hybrid vs Remote Trials: Choosing the Right Trial Model by Industry

i. For Nutraceutical Trials

The development of nutraceuticals is increasingly leaning towards consumer-centric and remote-first studies. These products are often aimed at healthy or near-healthy populations, and endpoints tend to involve self-reported outcomes or biomarkers, whose tracking doesn’t require invasive procedures done on-site.

 

Fully remote nutraceutical trials typically rely on diet and lifestyle tracking apps, virtual surveys, and online questionnaires for self-reporting.

 

Hybrid models can be useful in nutraceutical trials where blood tests are required, or to conduct initial screenings.

 

ii. For Medical Device Trials

Medical device studies often require hands-on components like training participants in device use, usability testing, or monitoring. Here, hybrid trials may be preferred, as they can support in-person interactions while allowing remote data collection and monitoring. For example, a wearable wellness device may require an on-site setup and tutorial but allow remote tracking via connected sensors for weeks or months.

 

iii. For Cosmetic Product Trials

Cosmetic product trials benefit from remote visual assessments using high-resolution imaging, AI-supported analysis, and digital diaries. These technologies play a crucial role in streamlining these studies, as participants can use apps to upload photos and complete surveys and diary entries from home. In some cases, hybrid trials may be needed to conduct detailed skin assessments by clinicians.

 

iv. For Pharmaceutical Trials

Regulatory agencies require robust pharmacovigilance and safety monitoring, which often translates into in-person interactions like physical exams and sampling or lab tests. While remote tools like ePROs and telehealth sessions can complement the drug development process, they can’t fully replace all in-person touchpoints. 

Hybrid trials meet this need by keeping critical safety assessments on-site while offering remote monitoring for less intensive touchpoints (for example, to collect PROs or using symptom tracking apps to provide continuous feedback in pre and post-market surveillance). 

In addition, pharmaceutical trials are subject to strict regulatory scrutiny regarding data privacy and integrity. In hybrid studies, some data is collected by qualified staff or under medical supervision, which facilitates compliance.

 

Regulatory and Compliance Considerations

The level of oversight needed in remote and hybrid trials is determined on a case-by-case basis depending on the trial’s risks and operational complexity.

 

In remote trials, DSMBs (Data & Safety Monitoring Boards)/DSMCs (Data & Safety Monitoring Committees) could take on a more prominent role with frequent reviews from a variety of decentralized sources, as these must comply with current guidelines on data security and participant verification, like the validation of eConsent with identity verification tools, or data transmission protocols that meet HIPAA or GDPR requirements.

 

In hybrid trials, oversight may still occur on-site, so DSMBs/DSMCs can often rely on more standardized or legacy monitoring procedures and GCP protocols. 

 

Depending on jurisdiction, trials must adhere to the following global guidelines:

 

 

Hybrid vs Remote Trials: Benefits and Limitations of Each Model

i. Benefits of Remote Trials

The advantages of remote trials include:

  • Patient-centric trials with a reduced participant burden  
  • Higher geographical reach  
  • Lower upfront costs  
  • Faster enrollment and onboarding 

 

ii. Benefits of Hybrid Trials

Hybrid trials offer multiple benefits, including:

  • Greater flexibility in protocol design and execution
  • Better participant retention through in-person rapport and support  
  • More diverse data, which potentially yields more reliable results
  • Clinical bio sample collection allowing for objective vs subjective data analysis
  • Support complex interventions and physical assessments
     

iii. Limitations & Risks to Consider

The main limitations around remote trials are the risk of digital exclusion for certain cohorts, the time and resources needed to train clinical teams in the use of tech tools, reliance on participant adherence, and ensuring that multiple tools and methods meet regulatory frameworks. 

Hybrid trials have their own limitations, including higher coordination and logistical efforts and potential cost increases after the initial stages.

 

How to Decide: Key Questions for Sponsors

Faced with the benefits and limitations of these clinical trial models, sponsors often wonder when to choose hybrid over fully remote trials. Here are some questions that can help choose between these clinical research models: 

 

  • What type of data do you need to collect?  
  • Is your target population tech-savvy?  
  • How complex is the intervention?  
  • Does the intervention require training or physical examination?  
  • How decentralized-ready is your protocol / existing tech systems? 

 


Real-World Use Cases & Trends

In the nutraceutical industry, fully remote studies have been successfully conducted through a combination of online questionnaires and digital diaries that evaluate the effect of a gut health supplement. 

Hybrid trials have been used in the medical device industry with great success. For example, a study evaluated a wearable device's ability to detect COVID-19 symptoms, combining remote enrollment, ePROs, and direct-to-participant device shipping, managing to enroll nearly 20,000 participants without site visits. 

Looking at current industry trends, we anticipate that clinical trial decentralization and success stories will become more common. In 2022, 89% of sponsors in the pharma industry had in place at least one DCT trial.

 

The prevalence of decentralized trials is likely to increase due to growing remote tech adoption, both by sponsors and by participants. 

In this scenario, CROs play a key role supporting studies that feature clinical trial decentralization. Through their know-how, they help streamline study setup, manage data securely, and ensure a seamless participant experience while guaranteeing compliance.  

According to our Chief Commercial Officer, Barry Skillington - “At Atlantia, we have been advising clients large and small for over 12 years, about best trial design, feasibility and value based on their project needs. Our deep understanding and knowledge of the clinical research space will benefit you and save you precious time and money in the long run.”

 

Final Thoughts

Hybrid and remote clinical trials offer unparalleled flexibility and patient-centricity, which are essential for successful implementation. When choosing between these two models, sponsors are advised to consult with an experienced CRO. 

As a CRO specializing in nutraceuticals, medical devices, cosmetics, and pharmaceuticals, Atlantia Clinical Trials offers the experience and infrastructure sponsors need for successful remote and hybrid trial execution. Our solid expertise in cardiovascular, metabolic health, immune health, chronic pain and other health areas allows us to create clinical research models that are efficient and engaging. 

If you're considering a decentralized or hybrid approach for your next study, get in touch with our Sales Team to explore the best trial design optimization strategies.

 

FAQs

What is the difference between hybrid and decentralized clinical trials?

Hybrid trials are a type of decentralized trial that combines remote and in-person elements, while full decentralized trials are entirely remote.

 

Are hybrid trials more effective than remote trials?

Effectiveness depends on the trial’s goals. Hybrid trials are better for interventions requiring physical assessments, but remote trials are better suited to improve convenience and reach.

 

How do hybrid trials ensure data integrity?

Hybrid trials combine on-site clinical-grade assessments with remote real-world data collection, ensuring high levels of data accuracy and completeness. 

 

How do hybrid trials work in the medical device industry?

Participants are often called for on-site training and setup. Devices can then be mailed to participants, and are subsequently monitored remotely.

 

Are remote clinical trials compliant with FDA regulations?

Yes, as long as they use validated tools, maintain data privacy, and follow FDA guidance.

 

Can nutraceutical trials be conducted remotely?

Yes. Nutraceutical trials can use remote tools for dietary tracking, symptom monitoring, and participant engagement and reporting.