Goals of Phase II Clinical Trials

hepatitis C virus

 

Having previously functioned as an infectious disease consultant at Danbury and New Milford Hospital in Connecticut while teaching at Yale University and New York Medical College, Robert Hindes, MD, serves as the chief medical officer of Trek Therapeutics. In his leadership role with the pharmaceutical developer, Robert Hindes, MD, oversees Phase II clinical trials for a next-generation treatment for hepatitis C virus, with a plan to develop affordable drugs for patients without access to effective therapies..

The primary objective of Phase II clinical trials is to establish the safety and therapeutic efficacy of a drug. Most importantly, companies must use Phase II trials to demonstrate a measurable benefit to the patient. Drugs in Phase II trials must also produce a primary response in the intended target; for example, an anti-cancer drug must actually display anti-cancer properties. Finally, Phase II trials enable researchers to expand the toxicological and pharmacological data collected in Phase I.

In terms of structure, Phase II clinical trials typically recruit approximately 100 to 200 subjects, but this number varies greatly among studies. Due to the relatively small sample sizes, the success of drugs in Phase II trials is assessed by observed differences between the drug(s) being studied and the placebo or active control arm, and generally not by statistical comparisons. Commonly referred to as “pilot” studies or proof-of-concept studies, Phase II trials determine whether a drug is a good candidate for larger, statistically powered Phase III trials in a larger population.

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