There is an increasing tendency for sponsors to combine the First-in-Human (FIH) single-dose and multiple-dose trials into one design, and even implement cohorts to study the effect of food or age.
Also, other early phase investigations, such as drug interactions (DDI), pharmacogenetics, QT prolongation and proof of concept (POC), can be included at an early stage of clinical development. This leads to complex designs combining different trials under one protocol.
However, even very complex designs can be made acceptable, both from an ethical and regulatory point of view, via an adaptive study protocol, allowing for flexibility to implement gained knowledge. It is paramount that the adaptive features of the trial are sufficiently detailed, clear and systematic.
We offer combined and adaptive clinical trials with a strategic plan, resulting in scientifically solid designs that are ethically compatible and meet regulatory requirements.
Why choose combined and adaptive clinical trials from SGS?
Our complex, adaptive early phase trials support helps you:
- Make a rapid progression from first administration in human to proof of concept
- Develop new medicines safely in a faster and more affordable way
- Get better information in less time and at lower research cost
- Development of complex designs, including adaptive protocols that focus on time saving
- Definition of study progression rules, safety boundaries and decision making
- Trial execution at our qualified clinical site – a Phase I unit in Antwerp, totaling 88 beds – and the experience to perform the appropriate actions after each step
- Data reviews and documentation at each decision-making time-point
- Regulatory support for the adaptive changes during study progression to ensure that most adjustments can be made without additional regulatory and EC submission
In the past years, over 75% of the FIH trials that we have performed have had a complex design and more than 40% had an adaptive design.
Contact us today to discuss how we can optimize your combined and adaptive clinical trials.