A hybrid trial is a type of clinical trial which includes both traditional and pragmatic clinical trial elements.
Randomized controlled trials are generally consider as the standard for evaluating efficacy and safety of drugs, biologics or medical devices regulatory decision-making. US FDA further establish a program to evaluate the potential use of real-world evidence (RWE) for regulatory purposes. In 2018, the FDA published the framework on its RWE program. In RWE program, one of the suggestion is to consider the hybrid trial – integration of a traditional randomized controlled trial with pragmatic design aspects to collect real-world data on patients.
Benefits of the hybrid clinical trial?
There are certainly considerable benefits –
- Hybrid design considers the benefit of the randomization.
- It also provides real-world outcome data while potentially accelerating product development.
- It lowers the cost of data collection and patient follow-up.