What are hybrid clinical studies?

In the context of clinical studies, hybrid means, for example, that 2 competing technological approaches are united, combined or present together. This can refer to study designs, selection of study participants, use of decentralised elements and on-site elements or - and this is what the following refers to - traditional with newer technological and digital elements.

Hybrid clinical studies are an innovative form of clinical research that combines traditional on-site methods with decentralised or digital elements.

Traditional generally means on-site appointments and documentation on paper (still existing in 2024), while depending on the study design and resulting risk-adapted specifications, almost every element can be conducted digitally. It is up to the creativity, experience and proof of regulatory compliance and safety of all parties involved to decide whether and which study elements can be implemented digitally.

Based on the information provided, the following main characteristics of hybrid studies can be emphasised:

• Combination of methods: Hybrid studies combine conventional on-site examinations in study centres with decentralised or digital components.
• Integration of examination or treatment methods that require human interaction because these are not possible digitally or are too risky.
• Flexibility for study participants: They allow patients to carry out part of the study activities from home or other locations outside traditional study centres or at times outside normal working hours.
• Use of technology: Digital technologies such as telemedicine, mobile apps or wearables are used to collect data and communicate with participants.
• Involvement of specialists: on-site or digital visits are also possible
• Improved accessibility: By reducing the need for frequent site visits, hybrid trials can facilitate participation for a wider range of trial participants.
• Increased efficiency: They can significantly speed up recruitment, recruit study participants over large spaces, improve patient retention and reduce costs compared to purely traditional studies.
• Data quality: Hybrid approaches potentially allow for more frequent and accurate data collection through the use of digital tools.
• Adaptability: Depending on the study design and requirements, the balance between on-site and digital elements may vary.

Legislation, guidelines and ethics committees often demand that people who are unable or unwilling to use digital media satisfactorily, even with support, should also have access to modern digital studies. This must always include the possibility of on-site appointments.

Hybrid clinical studies represent a promising approach to improving the efficiency and accessibility of clinical research while retaining the benefits of traditional methods, and offer the potential to modernise the conduct of clinical studies and make them more patient-friendly.

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