Proof-of-mechanism studies typically relate to the earliest stages of drug development, and for clinical research, this can include evaluating the effect of a new treatment on disease biomarkers, but not the clinical endpoints of the condition. A decision could be made at this point as to whether to progress the drug into later development.
Phase I studies are typically conducted with a small number of healthy volunteers who are given single doses or short courses of treatment and aim to demonstrate that the new drug is safe, can be tolerated, and provides guidance for the optimal dose that may show the desired clinical activity.
Phase II studies are key and very informative as they are typically designed to demonstrate clinical efficacy in the disease of interest. A successful Phase II study will indicate that the new drug provides clinical benefit, and can be tolerated when given to humans in the longer term with minimal side-effects.
Phase III studies involve a large number of subjects treated at doses and durations representative of the marketed use. These studies aim to show convincing, statistically significant evidence of efficacy and provide a detailed assessment of safety for the new drug. Given Phase III studies are successful, and the new drug is effective and safe, applications to the regulatory authorities (such as the US Food and Drug Administration and the European Medicines Agency) follow for getting access into the market.
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Our vision is to drive healthcare forward, and accelerate this progress with our unique insights, and with our ability to reimagine and reinvent. Our team is constantly striving to innovate and find novel solutions to provide state-of-the-art services, in all aspects of clinical research, ranging from clinical activities, to the establishment of research protocols, regulatory and ethics submission, data analysis, using innovative and novel methodological approaches, and preparing materials for publication.