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The development of targeted anti cancer drugs in recent years puts a challenge on classical trial designs. In this chapter we point out that defining a biological relevant dose might become more important than a MTD and establishing the mechanism of action becomes pivotal early in drug development. Furthermore we present examples of trails that show the importance of defining the patient population likely to benefit from targeted drugs. Furthermore, the use of surrogate tissues to evaluate the biological activity of the agents under study is described. Non-invasive techniques like PET, CT or MRI imaging are addressed as well as their present lack of validity in predicting patient outcome. Alternative endpoint in phase II trail designs in relation to the development of targeted anticancer drugs are described. [ABSTRACT FROM AUTHOR]