BRIDGING STUDIES
Do you need to ‘Bridge’ the gap?
When developing your global strategy, bridging trials play a crucial role in ensuring that data from one population can be effectively applied to another.
The main objective of bridging clinical trials is to determine whether the results from clinical trials conducted in one population (e.g., Caucasian) can be applied to another population (e.g., Asian or African) with different genetic, environmental, and demographic characteristics.
They enable the extrapolation of clinical data from one population to another, thereby facilitating the approval and registration of medical products in different regions or countries.
The E5 (R1) guidelines by the ICH provide a structured framework for designing these trials, ensuring that they account for the differences in demographics, genetics, and disease presentation between populations.
There are several types of bridging studies, including:
- Pharmacokinetic bridging studies: These studies compare the absorption, distribution, metabolism, and excretion of a drug in different populations.
- Pharmacodynamic bridging studies: These studies evaluate the effects of a drug on the body in different populations.
- Efficacy bridging studies: These studies assess the effectiveness of a drug in treating a specific disease or condition in different populations.
The benefits of running Bridging Clinical Trials in Australia
Australia offers a unique combination of factors for running your bridged study. It has a:
- Sophisticated & scalable research environment
- Robust regulatory environment
- Efficient timelines and cost-effectiveness
- Experienced professionals
Get in touch with us to learn how we can support your bridging clinical trials in Australia as part of your clinical development strategy.
Looking to ‘Bridge’ the gap?
If you’re looking to bridge the gap in your clinical trial program, we can help you design and execute these trials in Australia, guiding you through every step of the process.
