Methodology of clinical trials with new molecular-targeted agents: where do we stand?

@article{Morabito2006MethodologyOC,
  title={Methodology of clinical trials with new molecular-targeted agents: where do we stand?},
  author={Alessandro Morabito and Massimo Di Maio and Ermelinda De Maio and Nicola Normanno and Francesco Perrone},
  journal={Annals of oncology : official journal of the European Society for Medical Oncology},
  year={2006},
  volume={17 Suppl 7},
  pages={
          vii128-31
        }
}
In recent years, we have witnessed growing interest in the methodology of clinical trials with molecular-targeted agents. In phase I studies, alternative end points to toxicity have been proposed to define the optimal biological dose: the identification of a 'target effect', the measurement of 'surrogates' for biological activity and the assessment of drug plasma levels. However, these end points are not routinely incorporated into the study design and have rarely formed the primary basis for… CONTINUE READING

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