How hybrid models and technology are shaping the future of clinical research

The world of clinical trials is changing rapidly. Today, the rise of decentralized clinical trials (DCTs) and hybrid models has transformed the landscape, offering a more flexible, patient-centered approach that breaks down traditional barriers. With technological advances – particularly in mobile health applications, telemedicine and wearables – clinical research is becoming more efficient, accessible and inclusive.

GlobalData’s clinical trial database currently tracks 16,076 decentralized clinical trials worldwide, in various stages from planning to completion. This includes 9,291 drugs and 9,108 companies.

Increasing adoption of decentralized clinical trials

According to GlobalData’s clinical trial database, the rate of adoption of decentralized clinical trials has been particularly pronounced following the disruption caused by the COVID-19 pandemic, which has accelerated the need for trials to be conducted without traditional site-based constraints. During this period, DCTs provided a crucial means of ensuring continuity, allowing patient recruitment and data collection to continue remotely. As a result, many sponsors have now realized that decentralized approaches can increase efficiency, reduce costs and provide access to more diverse participant groups.

Global coverage: expanding patient access

One of the most significant advantages of DCTs is their ability to expand the geographic and demographic coverage of clinical trials. Traditionally, site studies have been limited to participants living within a reasonable distance of the trial site. This has often resulted in the under-representation of certain populations, particularly those in rural or underserved areas.

The geographic scope of decentralized studies has expanded significantly, with multinational studies becoming more common. GlobalData data shows a clear increase in the number of decentralized studies covering multiple countries, reflecting DCT’s ability to access more diverse participant groups. This is particularly important for studies investigating conditions that disproportionately affect certain populations or that require a large population to generate comprehensive results.

The DCT market has a global reach. North America continues to move toward increased use of DCT trials as large US-based pharmaceutical sponsors look for new ways to streamline clinical trials, and DCTs have proven to be effective in this regard.

By eliminating the need for participants to travel to trial sites, DCTs also facilitate the participation of those with limited mobility or who cannot take time off from work. This not only increases trial inclusivity, but also speeds recruitment time, as participants are more likely to enroll if the process is convenient.

Key Mobile Components in Decentralized Studies

The success of DCT and hybrid models is highly dependent on the use of mobile components such as apps, telemedicine platforms and wearable devices. These tools are essential for collecting real-time data, monitoring patient health, and ensuring ongoing engagement throughout the trial period. The use of mobile components has steadily increased in tests over the past few years, according to the GlobalData database.

Mobile apps are a key element, providing participants with a simple way to record their daily health metrics, complete surveys and report any adverse events. Wearable devices are proving invaluable for studies that require continuous monitoring of vital signs – such as heart rate, blood pressure and glucose levels. These devices enable the remote collection of high-quality data that would otherwise require frequent clinic visits.

Telemedicine also plays an essential role in the decentralized study model. By enabling virtual consultations, telemedicine reduces the need for in-person visits, making studies more convenient for participants. It also allows for more frequent interactions between patients and study coordinators, improving oversight and addressing any concerns participants may have in real time.

Hybrid models: the best of both worlds

While fully decentralized trials are gaining popularity, hybrid clinical trials are emerging as the preferred option for many sponsors. These studies combine decentralized methods such as remote monitoring and virtual patient engagement with in-person visits for procedures that cannot be performed remotely. The flexibility of the hybrid model allows traditional, site-based elements to be included when needed, while taking advantage of the efficiencies offered by decentralized approaches.

Incorporating elements such as mobile apps, telemedicine consultations and wearable devices enables continuous patient monitoring, significantly reducing the need for in-person visits while maintaining data integrity and patient safety. This balance between remote and on-site involvement is especially valuable for complex studies that require specialized procedures that can only be performed in a clinical setting.

The hybrid approach also addresses one of the most significant challenges of DCT: ensuring patient compliance and collecting high-quality data. By integrating decentralized technologies with traditional methods, sponsors can provide attendees with a more personalized and flexible experience. This reduces dropout rates and improves patient retention, leading to more reliable study results.

The role of technology in driving hybrid decentralization

At the heart of the decentralization movement is the widespread adoption of advanced digital technologies. Mobile apps, wearables, telemedicine, and electronic patient reported outcomes (ePROs) have become indispensable tools for conducting DCT and hybrid studies. These technologies not only facilitate the participation of trial participants, but also improve the quality and timeliness of the data collected.

Datacubed is one of the companies leading the charge in this digital transformation. Offering an intuitive platform that seamlessly integrates with mobile technologies, Datacubed helps sponsors design and manage decentralized and hybrid tests more efficiently. Their platform enables real-time data collection, patient monitoring and remote engagement, all of which are crucial to the success of modern clinical trials. By using remote monitoring, Datacubed helps clinical trials collect patient data more frequently and in a timely manner, monitor and track patient progress, and make real-time adjustments.

The Datacubed platform addresses several key challenges facing hybrid clinical trials, such as maintaining data integrity and ensuring patient compliance. Its DCT platform has been proven to deliver 90% compliance and 80% patient retention, incorporating technologies such as eCOA/ePRO, eConsent, geofencing and television.

Through mobile apps, participants can easily record their symptoms, fill out questionnaires and even communicate with study coordinators. Integrating the platform with wearable devices enables continuous monitoring of vital signs, providing researchers with real-time information on a participant’s health status. This real-time data collection is critical to making timely decisions about patient care and process adjustments.

Overcoming regulatory and compliance challenges

As decentralized trials become more widespread, sponsors must navigate a complex regulatory landscape. Each country involved in a multinational trial may have different regulations regarding patient confidentiality, data sharing, and clinical oversight. Moreover, the use of digital platforms introduces new challenges related to data security and compliance with global standards such as the General Data Protection Regulation (GDPR) and the Health Insurance Portability and Accountability Act (HIPAA).

Datacubed has been proactive in addressing these regulatory challenges by building robust compliance features into its platform. The company works closely with regulatory bodies to ensure that its systems meet the strict requirements of various jurisdictions. This not only helps protect patient data, but also ensures that studies remain compliant regardless of where participants are located.

The future of clinical trials is hybrid

The rise of decentralized and hybrid clinical trials represents a fundamental change in the way medical research is conducted. As data from GlobalData illustrates, these models are not just a passing trend, but are becoming a cornerstone of modern clinical research.

According to a GlobalData survey, patient recruitment and participation are the main drivers for the adoption of decentralized clinical trials in the future. While many respondents used DCTs before the pandemic – especially in North America and Europe – 37% now plan to use DCTs specifically after seeing the benefits. Additionally, many others stated that DCTs are already planned, the pandemic has just accelerated their adoption. A total of 74% of respondents believed that DCTs will be most commonly used in the next one to four years.

Looking ahead, the continued growth of decentralized and hybrid models will likely reshape the clinical trial landscape even further. With the adoption of new technologies and the increasing acceptance of remote employment, clinical trials will become more inclusive, efficient and patient-centered. As more sponsors adopt these models, the industry will continue to evolve, bringing lifesaving treatments to market faster and more efficiently than ever before.

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