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Clinical Drug Development

Clinical drug development has a very long history but is still a very dynamic environment, hence the chapter focuses on clinical trials in pharmaceutical research and their core purpose to acquire data on the safety/tolerability and efficacy of pharmaceutical interventions related to health/disease. Drug development can now take as much 25 thousand patient years, over 15 years, and can have a significant post registration commitment, creating a tremendous amount of data on a therapeutic intervention. This is all driven by changes in demands by patients, physicians, regulators and payors to various extents. Clinical trials can be sorted in various ways; one is by the intentions of the investigator, and can be observational or interventional where for the latter the best controlled trial is the prospective, randomized, placebo controlled double dummy randomized controlled trial. Secondly, the preferred investigation is by newly generating data or a prospective trial but in situations where the forward/prospective generation of a new data set is not needed/possible or warranted, existing data can be used; the type of trials that investigate data that are already generated are called retrospective. A third approach discussed is to categorize trials towards the projected outcome of the trial. We also address the various phases of drug development, from observational phase zero studies via entry into man or phase I, dose finding or phase II, label generating studies or phase III to post marketing studies or phase IV.

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09 Dec 2014
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