What is a ProtoTrial?
A ProtoTrials is an in vitro GCLP translational immunology study performed on samples from human patients and healthy volunteers. ProtoTrials are adaptive and collaborative in nature and typically assesses drugs targeting an immune mechanism.
ProtoTrials can be used to:
- Allow early insight into the efficacy, safety and MOA of a drug.
- Refine target indication.
- Generate serendipitous discoveries of interesting aspects of drug performance.
- Focus the clinical biomarker panel and analytical techniques.
- Benchmark the candidate drug against other drug leads and commercially available competitor products.