作者: Wendy R. Parulekar , Daniel J. Sargent
DOI: 10.1007/978-1-4419-7358-0_7
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摘要: The primary objective of a phase III clinical trial is to demonstrate or confirm the therapeutic benefit new treatment strategy when compared with an alternate treatment, usually current standard care. Due modest incremental benefits seen most anticancer agents, studies generally require large sample sizes and considerable resource allocation. Thus, decision conduct study must be carefully considered. Comprehensive pharmacokinetic pharmacodynamic supporting data should present, including preclinical information regarding absorption, distribution, metabolism, excretion different dosing schedules as well drug interactions any ethnic/gender specific differences in these parameters. Pharmacodynamic interest includes on toxicity antitumor activity. traditional measure activity has been tumor response measured by standardized criteria such RECIST [1]. While shrinkage was frequently considered adequate for cytotoxic chemotherapy, it may not entirely appropriate solid tumors difficult radiological endpoints prostate ovarian cancer molecularly targeted agents whose main mechanism action described cytostatic rather than cytocidal. Additional signals have proposed changes serum marker levels [2, 3] measures progression rates [4, 5] risk [6] Research validate other ongoing.