Combined and/or adaptative protocols offer the potential for achieving multiple objectives in a single first-in-human (FIH) clinical trial. Single ascending dose (SAD) protocols are combined with multiple ascending dose (MAD) protocols, often with specific protocols for age or food effect, drug-drug interactions or proof of concept (POC). Operating in this way enables cost reductions while maintaining safety and effectiveness.
Why choose combined and adaptive clinical trials from SGS?
We offer a comprehensive range of consultancy services to support the development and execution of complex and adaptive early phase clinical trials. In recent years, 75% of FIH trials at our clinical pharmacology unit (CPU) incorporate complex design protocols, with nearly 50% containing adaptive features. Most FIH studies also contain pharmacodynamic read outs to enable pharmacology assessment and/or POC.
Our expert teams design the combined approach, ensuring compliance with regulatory requirements and ethics committees. They will help define the study’s progression rules and safety boundaries, a vital component of any trial design process.
SGS is recognized as the benchmark for quality and integrity in clinical trials. Our solutions ensure you can optimize relevant data collection while ensuring safety and reducing the time spent conducting the trial.
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Polo Tecnológico de Lisboa,
Rua Cesina Adães Bermudes 5, Lote 11, 1600-604,
Lisbon,
Portugal