What is a Hybrid Clinical Trial?

A hybrid clinical trial is a study design that incorporates elements of traditional in-person clinical trials with decentralized clinical trial (DCT) components. In a hybrid trial, participants may still be required to attend physical clinical sites for certain procedures. However, other study activities can be conducted remotely by clinical investigators using digital health technologies, including mobile apps, wearable devices, telehealth visits, and so forth.

There are several formats in which clinical trial designs and protocols may be presented. Three principal designs can be identified: the traditional in-person format, the completely remote format, and the hybrid format. The distinguishing feature of hybrid trials is the degree of decentralization, which sets them apart from the other trial models.

• It is imperative that participants attend all in-person visits at clinical sites for all study activities.
• While the environment is highly controlled, challenges persist in patient recruitment and retention.

• The majority of trial activities are conducted remotely, obviating the necessity for in-person visits.
• This approach offers patients enhanced accessibility and convenience, though it may result in diminished oversight and control.

• It is recommended that both in-person and remote/virtual trial components be combined in the trial design.
• Furthermore, it is essential to ensure that the scientific rigor of RCTs is maintained while incorporating real-world data collection.

The objective of hybrid trials is to achieve a balance between the advantages of randomization and control groups in traditional RCTs and the patient-centric benefits of decentralized approaches.

Improved Patient Engagement and Retention:

• The burden on participants was reduced by limiting the number of site visits.
• The capacity to gather authentic, real-world data on an ongoing basis through remote monitoring.

Accelerated Study Timelines and Reduced Costs:

• The possibility of obtaining additional data points and outcomes.
• The data collection process is more streamlined than that of traditional trials.

Increased Diversity and Representativeness of Study Populations:

The capacity to enroll participants who may experience logistical challenges in traveling to clinical sites is a valuable asset.

Enhanced Flexibility and Adaptability:

Researchers are able to implement data-driven adjustments to study protocols during the course of the trial process. This allows for modifications to be made in order to maintain the relevance and efficiency of the trial.

Although hybrid trials present a multitude of advantages, sponsors must also address a number of challenges when designing such trials. The principal challenges that must be addressed are as follows:

Data Security and Patient Privacy: The objective is to guarantee the secure collection and storage of sensitive patient data from remote sources.

Oversight and Data Quality: The maintenance of appropriate levels of monitoring and control over data collection in a decentralized setting is of paramount importance.

Regulatory Acceptance: Obtaining regulatory approval for the utilization of innovative digital technologies and remote data collection methodologies.

In light of the ongoing evolution of the clinical trial landscape in response to a multitude of societal, environmental, and economic factors, it is inevitable that hybrid trial designs will become a dominant feature. The combination of traditional and decentralized approaches in hybrid trials offers the potential to overcome many of the recognized challenges in clinical research, such as:

• Enhancing the recruitment and retention of patients. Hybrid models have the potential to enhance accessibility and convenience for a diverse range of patient populations in clinical trials.
• Enhancing the quality and completeness of data: The implementation of remote monitoring and digital data collection can facilitate the acquisition of data that is both more comprehensive and more continuous.
• Reducing the time required for drug development: The implementation of hybrid trials has the potential to streamline processes and reduce the costs associated with traditional trials.
• Increasing Regulatory Acceptance: Health authorities are demonstrating an increasing receptivity to the utilization of real-world data and digital technologies in the context of clinical trials.

It is our belief that the hybrid clinical trial model represents a significant advance in the conduct of clinical research, offering the potential to make it more patient-centric, efficient, and representative of the real-world patient population. As the industry continues to embrace this innovative approach, we look forward to seeing more and more independent community pharmacists becoming involved in order to drive clinical research forward even further.

[1] https://www.datacubed.com/what-is-a-hybrid-clinical-trial/

[2] https://www.sciencedirect.com/science/article/pii/S1551714419305713

[3] https://www.clinicalleader.com/doc/embracing-hybrid-trial-design-how-when-why-to-use-it-0001

[4] https://www.archemedx.com/corp-blog/decentralized-virtual-hybrid-clinical-trial-whats-the-difference/