This whitepaper examines key considerations to take into account when deciding whether to run a standard FIH in HVs or a hybrid FIH clinical trial.
FIH clinical trials have evolved from traditional dose and toxicity-finding studies in HVs, to innovative complex study designs – sometimes requiring patients’ involvement. Hybrid trials offer a potential solution, allowing clinical study teams to enjoy the benefits of using both HV and patients whilst mitigating the potential downsides.
This whitepaper examines the key considerations to take into account when deciding whether to run a standard FIH in HVs or a hybrid FIH clinical trial.
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