Despite the gains that had been made in increasing overall survival and extending disease-free survival rates, cancer is still one of the leading causes of death in the United States [1]. There remains an urgent need for the rapid development of new cancer therapeutics. Unfortunately, only about 5% of new compounds intended for use in cancer therapy are approved for clinical use [2]. The time and enormous costs involved in conducting clinical trials are special barriers to drug development [3, 4]. Careful thought regarding each phase of investigation is critical for the successful and efficient completion and interpretation of a clinical trial and prior to widespread clinical use of a new drug. This chapter focuses on clinical trials in oncology and translational applications. The global objectives of cancer clinical trials are to evaluate promising, new agents that may alleviate symptoms and/or cure the disease. As newer agents such as molecular targeted therapies are developed, questions remain as to whether current models of clinical trial design are sufficient. Nevertheless, classic design forms the basis of drug development in cancer therapy. Study objectives and endpoints are associated with specific study designs and determine the level of testing and the number of subjects required for each phase (Fig. 1) [5].

Original languageEnglish
Title of host publicationPharmaceutical Perspectives of Cancer Therapeutics
PublisherSpringer US
Number of pages11
ISBN (Print)9781441901309
StatePublished - 2009


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