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Clinical Trials
Clinical trials (CT) are a key component in the drug development process. Clinical development may last several years and is the final stage in development before the drug is released to market. The various stages in CT are assigned with phase numbers indicating the nature of the study and correlating with the drug’s proximity to the final regulatory submission, after which a product is released into the market.
Clinical studies are usually performed in three main phases:
In Phase I the drug is first presented to human subjects ("First in Human"), after undergoing methodical preclinical and toxicology studies in animals, in order to evaluate its safety and tolerability.
Once this stage is successfully completed, the company can continue to Phase II which is a preliminary evaluation of the new therapy’s efficacy as well as continue to explore the safety profile. This phase is often divided into Phase IIa and Phase IIb which examine dosing and efficacy, respectively.
The last step, Phase III, investigates the efficacy of the new drug in the target population and is usually performed in a large sample size in order to provide a statistically valid definitive efficacy assessment. Once completed, the Clinical Development (presented as "Clinical Reports" of the different trials) is then evaluated by the competent regulatory authority in the country where the company is seeking approval. The regulatory authority’s role is to determine whether all clinical development goals have been achieved.
In some cases Phase IV development is also required. This is a post marketing stage intended to collect additional data on safety and/or efficacy.
Several of Kamada’s products are currently in clinical development stages:
For additional information, please contact:
Pnina Strauss
Clinical Development & IP Manager
pninas@kamada.com
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