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lüll What are the reasons for negative phase III trials of molecular-target-based drugs?Saijo NCancer Sci 2004[Oct]; 95 (10): 772-6The results of molecular-biological studies of cancer are changing the way we diagnose and treat cancer. Target-based drug discovery selects agents for development based on their mechanisms of action. The interaction between target-based drugs and their targets can be described by classical drug-receptor theory. Clinical trials have demonstrated that some effective target-based drugs induce apoptosis, even though they are considered to be cytostatic. Numerous phase III trials of target-based drugs have been conducted. Although some have yielded strongly positive results, the majority of the results have been negative. This article seeks to clarify the value of molecular-target-based therapy and to discuss the reasons for negative results in phase III trials. The importance of proof-of-principle studies is stressed throughout preclinical and clinical trials of molecular-target-based drugs.|*Drug Delivery Systems[MESH]|Antineoplastic Agents/classification/pharmacology/*therapeutic use[MESH]|Clinical Trials as Topic[MESH]|Clinical Trials, Phase III as Topic[MESH]|Drug Design[MESH]|Humans[MESH]|Treatment Outcome[MESH] |