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Clinical Design: Clinical studies are the heart of the drug development decision-making process, and careful design of these costly experiments is fundamental to effective testing of critical scientific hypotheses.
The focal points of this process are the key scientific questions that must be explored in order to determine the safety and efficacy of a molecule. For each asset, we break down the most important scientific issues into very specific questions that can be answered with focused clinical experiments.
Once key scientific questions are identified, the clinical experiment is then designed to determine answers in the safest and most effective manner for healthy volunteers and patients. To augment our internal expertise, we network with the most published and experienced academic and industry researchers around the world. A foundation of knowledge is established with input from these individuals and the questions are refined. At this point, the approach to hypothesis resolution is often crafted through the use of new and innovative technologies, unique biological markers that allow for early indicators of pharmacological response (safety and efficacy), novel surrogates/models for disease states, and adaptive clinical trial design. These creatively designed trials, along with the ability to skillfully initiate and execute these plans, are pivotal to Chorus's success.
- Can the molecule be safely administered at levels that will produce a pharmacodynamic response?
- Can the biomarker provide an appropriate pharmacodynamic response in order to facilitate dose selection for Phase 2 studies?
- Will the molecule demonstrate a pharmacodynamic response in healthy volunteers through the disease state surrogate test?
Once key scientific questions are identified, the clinical experiment is then designed to determine answers in the safest and most effective manner for healthy volunteers and patients. To augment our internal expertise, we network with the most published and experienced academic and industry researchers around the world. A foundation of knowledge is established with input from these individuals and the questions are refined. At this point, the approach to hypothesis resolution is often crafted through the use of new and innovative technologies, unique biological markers that allow for early indicators of pharmacological response (safety and efficacy), novel surrogates/models for disease states, and adaptive clinical trial design. These creatively designed trials, along with the ability to skillfully initiate and execute these plans, are pivotal to Chorus's success.
