DEVISING PROOF-OF-CONCEPT STRATEGIES IN ONCOLOGY CLINICAL TRIALS

摘要: Publisher Summary This chapter discusses proof-of-concept strategies in oncology clinical trials. A program can offer efficiency the drug development process through pre-phase I planning and identification of important safety, activity, competitive landscape criteria that must be met. Determining degree correlation surrogate end point to benefit is essential assigning a value its inclusion study development. An focus proof-of- concept point, which predictive primary phase III point. The application statistical analysis central element for program. Statistical includes sample size estimates assure an adequate number patients are enrolled purposes assessing safety pharmacodynamics, pharmacokinetics, predictability marker It suggested when based on newly established points, greater understanding mechanism action putative links considered. found reliable method measuring any pharmacokinetic or pharmacodynamic used studies proper interpretation results.