ABSTRACT
INTRODUCTION Over the past decade a series of phase III clinical trials in cancer vaccinology has come to an end showing a disappointingly high rate of failure. Irrespective of this lack of success, the promise of cancer vaccine therapy has remained strong and has led various stakeholders ( academia, industry, regulators, and so on) to closely examine the reasons for past trial failures. In this process it has become evident that a major limitation rested in the status quo rules for planning and evaluating clinical trials, which was mainly based on the development paradigm from cytoreductive chemotherapy.
